{"id":12545,"date":"2026-03-23T12:39:57","date_gmt":"2026-03-23T11:39:57","guid":{"rendered":"https:\/\/dhc.ima.vc\/gxp-friendly-audit-fuer-saas-plattform\/"},"modified":"2026-05-09T20:18:18","modified_gmt":"2026-05-09T18:18:18","slug":"gxp-friendly-audit-fuer-saas-plattform","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/","title":{"rendered":"GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12545\" class=\"elementor elementor-12545 elementor-5860\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f897850 e-con-full e-flex e-con e-parent\" data-id=\"f897850\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ae80faa e-flex e-con-boxed e-con e-child\" data-id=\"ae80faa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-21d8f3a e-con-full e-flex e-con e-child\" data-id=\"21d8f3a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2f1a1d65 e-flex e-con-boxed e-con e-parent\" data-id=\"2f1a1d65\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-8b07514 e-con-full e-flex e-con e-child\" data-id=\"8b07514\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5e177196 e-con-full e-flex e-con e-child\" data-id=\"5e177196\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2749cd7f elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"2749cd7f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7755013d elementor-widget elementor-widget-text-editor\" data-id=\"7755013d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-testid=\"markdown-response\"><p id=\"message\">Im Rahmen eines unabh\u00e4ngigen <strong>GxP-Friendly Audits<\/strong> wurde die <strong>SaaS-Plattform\u00a0Ledidi\u00a0Trials<\/strong> durch DHC umfassend bewertet. Ziel war die strukturierte, transparente und risikobasierte Beurteilung der regulatorischen Eignung f\u00fcr den Einsatz in GxP-regulierten klinischen Studien.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17a14cbf elementor-author-box--align-left elementor-author-box--layout-image-left elementor-widget elementor-widget-author-box\" data-id=\"17a14cbf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/Thomas-Pauly-300x300.webp\" alt=\"Picture of Thomas Pauly, Practice Manager, DHC GmbH\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\t\t\t\t\t<div >\n\t\t\t\t\t\t<div class=\"elementor-author-box__name\">\n\t\t\t\t\t\t\tThomas Pauly, Practice Manager, DHC GmbH\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6194c5a2 e-con-full e-flex e-con e-child\" data-id=\"6194c5a2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-571a5a01 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"571a5a01\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"350\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp\" class=\"attachment-full size-full wp-image-15564\" alt=\"Zwei Personen in Laborkleidung betrachten ein Tablet \u2013 symbolisch f\u00fcr die Bewertung einer GxP-konformen SaaS-Plattform f\u00fcr klinische Studien.\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp 1200w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit-300x88.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit-1024x299.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit-768x224.webp 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-49e17216 e-flex e-con-boxed e-con e-parent\" data-id=\"49e17216\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7989692a e-con-full e-flex e-con e-child\" data-id=\"7989692a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4ab08e4a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4ab08e4a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Der Beitrag zeigt, wie sich die Audit-Ergebnisse als Supplier Evidence f\u00fcr eine <strong>risikobasierte Lieferantenqualifizierung<\/strong> nutzen lassen \u2013 und dass das Audit die kundeninterne <a href=\"https:\/\/dhc.ima.vc\/softwarevalidierung\/\"><strong>Validierung (CSV\/CSA)<\/strong><\/a>\u00a0nicht ersetzt, sie aber typischerweise deutlich beschleunigt und verschlankt.<\/p><p style=\"text-align: left;\">Die regulatorische Bewertung von SaaS-Plattformen, die f\u00fcr\u00a0GxP-relevante Prozesse eingesetzt werden\u00a0sollen, sind von hoher Bedeutung. Insbesondere bei cloudbasierten L\u00f6sungen stehen Themen wie Datenintegrit\u00e4t, elektronische Signaturen, IT-Sicherheit und Lieferantenqualifizierung im Fokus.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f944eeb e-flex e-con-boxed e-con e-parent\" data-id=\"f944eeb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2871744 e-con-full e-flex e-con e-child\" data-id=\"2871744\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49ea18a elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"49ea18a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Was ist ein GxP\u00a0Friendly Audit?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41fe603 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"41fe603\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Ein GxP\u00a0Friendly Audit ist ein <strong>unabh\u00e4ngiges, vorbereitendes Audit ohne formale Inspektionsfunktion<\/strong>.<\/p><p style=\"text-align: left;\"><strong>Es dient der:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Bewertung der regulatorischen Reife eines Systems oder SaaS-Anbieters<\/li><li>Identifikation m\u00f6glicher Compliance-Risiken und &#8211; optional \u2013 Aufzeigen von Handlungsempfehlungen<\/li><li>Unterst\u00fctzung der risikobasierten Lieferantenqualifizierung (Supplier Qualification)<\/li><li>Vorbereitung auf Kundenaudits oder Beh\u00f6rdeninspektionen<\/li><\/ul><p style=\"text-align: left;\">Im Gegensatz zu klassischen Lieferantenaudits steht hier die\u00a0unterst\u00fctzende, strukturierte Analyse der\u00a0GxP-Readiness\u00a0im Vordergrund.<\/p><p style=\"text-align: left;\">Gerade f\u00fcr SaaS-Anbieter im regulierten Umfeld ist ein Friendly Audit ein strategisches Instrument\u00a0in Hinblick auf die GxP Compliance.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4abd488 e-flex e-con-boxed e-con e-parent\" data-id=\"4abd488\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b97ffdf e-con-full e-flex e-con e-child\" data-id=\"b97ffdf\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-26e241f elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"26e241f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u00dcber Ledidi Trials<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-655cda3 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"655cda3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\"><a href=\"https:\/\/ledidi.com\/platform\/features\/platform-features-trials-module\" target=\"_blank\" rel=\"noopener noreferrer nofollow\"><img decoding=\"async\" class=\"alignright wp-image-11372 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/ledidi.webp\" alt=\"Logo von Ledidi, Anbieter von Software f\u00fcr klinische Daten und Forschung\" width=\"300\" height=\"157\" \/><\/a>Ledidi\u00a0ist ein Technologieunternehmen mit Fokus auf digitale L\u00f6sungen f\u00fcr datengetriebene klinische Forschung. Ziel ist es, Sponsoren, CROs und Studienteams durch moderne Softwareans\u00e4tze eine effizientere Studienplanung, -durchf\u00fchrung und -auswertung zu erm\u00f6glichen.<\/p><p style=\"text-align: left;\">Mit\u00a0Ledidi\u00a0Trials bietet das Unternehmen eine <strong>SaaS-basierte Plattform zur Unterst\u00fctzung klinischer Studienprozesse<\/strong>. Schwerpunkte sind:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>strukturierte Datenverarbeitung<\/li><li>kollaborative Arbeitsprozesse<\/li><li>Transparenz zwischen Studienbeteiligten<\/li><li>digitale Unterst\u00fctzung regulatorischer Anforderungen<\/li><\/ul><p style=\"text-align: left;\">Die L\u00f6sung ist f\u00fcr den Einsatz in regulierten klinischen Forschungsumgebungen konzipiert und wird kontinuierlich weiterentwickelt, um aktuellen regulatorischen und industriellen Anforderungen gerecht zu werden.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3b052d1 e-flex e-con-boxed e-con e-parent\" data-id=\"3b052d1\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-86dc434 e-con-full e-flex e-con e-child\" data-id=\"86dc434\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-07124c9 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"07124c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Auditansatz und regulatorischer Rahmen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fcd44c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"1fcd44c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Das Audit wurde als unabh\u00e4ngiges, risikobasiertes GxP-Friendly Audit durchgef\u00fchrt und orientierte sich an internationalen regulatorischen Anforderungen und Leitlinien, darunter:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>FDA 21 CFR Part 11 (Elektronische Aufzeichnungen und elektronische Signaturen)<\/li><li>ICH GCP E6(R3)<\/li><li>ISPE GAMP 5 (risikobasierter Ansatz f\u00fcr computergest\u00fctzte Systeme)<\/li><\/ul><p style=\"text-align: left;\">Der Fokus lag auf einer lieferantenseitigen Bewertung der:<\/p><ul class=\"check-list\"><li style=\"text-align: left;\">Angemessenheit des Qualit\u00e4tsmanagementsystems<\/li><li style=\"text-align: left;\">Wirksamkeit der Entwicklungs- und Kontrollmechanismen<\/li><li style=\"text-align: left;\">Eignung der Betriebsprozesse<\/li><li style=\"text-align: left;\">Eignung f\u00fcr den Einsatz in GxP-regulierten klinischen Studien<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a186792 e-flex e-con-boxed e-con e-parent\" data-id=\"a186792\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2a6a54a e-con-full e-flex e-con e-child\" data-id=\"2a6a54a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-64385fb elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"64385fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Umfang des GxP-Audits f\u00fcr die SaaS-Plattform<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9de4a88 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"9de4a88\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Das Audit umfasste folgende zentrale Pr\u00fcfbereiche:<\/p><p style=\"text-align: left;\"><strong>Qualit\u00e4tsmanagementsystem (QMS)<\/strong><\/p><ul style=\"text-align: left;\"><li>Struktur und Dokumentation<\/li><li>Rollen- und Verantwortlichkeitsmodelle<\/li><li>CAPA- und \u00c4nderungsmanagement<\/li><\/ul><p style=\"text-align: left;\"><strong>Software Development Lifecycle (SDLC)<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Entwicklungsprozesse<\/li><li>agile Methoden und Dokumentation<\/li><li>Traceability\u00a0und Nachvollziehbarkeit<\/li><\/ul><p style=\"text-align: left;\"><strong>Release- und Change-Management<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>formalisierte Freigabeprozesse<\/li><li>kontrollierte Versionsverwaltung<\/li><li>Impact- und Risikoanalysen<\/li><\/ul><p style=\"text-align: left;\"><strong>SaaS-Betrieb und IT-Sicherheit<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Zugriffskontrollen<\/li><li>rollenbasierte Berechtigungen<\/li><li>elektronische Signaturen<\/li><li>Datensicherheitsmassnahmen<\/li><\/ul><p style=\"text-align: left;\"><strong>Datenintegrit\u00e4t und Business Continuity<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Backup-Strategien<\/li><li>Disaster Recovery<\/li><li>Business Continuity Management<\/li><li>Audit Trails<\/li><li>Sicherstellung\u00a0von ALCOA+-Prinzipien<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4d5792e e-flex e-con-boxed e-con e-parent\" data-id=\"4d5792e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-84118aa e-con-full e-flex e-con e-child\" data-id=\"84118aa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3882fbe elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3882fbe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ergebnis des Audits<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-80391f8 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"80391f8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Das unabh\u00e4ngige\u00a0Friendly\u00a0Audit best\u00e4tigte, dass\u00a0Ledidi\u00a0Trials ein <strong>umfassendes und strukturiertes\u00a0Qualit\u00e4tssystem<\/strong> implementiert hat.<\/p><p style=\"text-align: left;\">Der abschliessende Auditbericht enth\u00e4lt <strong>keine offenen Abweichungen<\/strong> und best\u00e4tigt die grunds\u00e4tzliche Einsatzbereitschaft der Plattform f\u00fcr\u00a0GxP-regulierte klinische Studien.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e86d2a2 e-flex e-con-boxed e-con e-parent\" data-id=\"e86d2a2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ffbb15e e-con-full e-flex e-con e-child\" data-id=\"ffbb15e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-85b56d1 elementor-widget__width-initial elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"85b56d1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-quote-left\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M464 256h-80v-64c0-35.3 28.7-64 64-64h8c13.3 0 24-10.7 24-24V56c0-13.3-10.7-24-24-24h-8c-88.4 0-160 71.6-160 160v240c0 26.5 21.5 48 48 48h128c26.5 0 48-21.5 48-48V304c0-26.5-21.5-48-48-48zm-288 0H96v-64c0-35.3 28.7-64 64-64h8c13.3 0 24-10.7 24-24V56c0-13.3-10.7-24-24-24h-8C71.6 32 0 103.6 0 192v240c0 26.5 21.5 48 48 48h128c26.5 0 48-21.5 48-48V304c0-26.5-21.5-48-48-48z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4611133 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4611133\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><em>\u201eDas Friendly Audit von DHC und der daraus resultierende Bericht lieferten uns inspektionsbereite Nachweise zu elektronischen Aufzeichnungen und Signaturen, Audit Trails sowie R\u00fcckverfolgbarkeit \u2013 ausgerichtet an anerkannten regulatorischen Erwartungen. Dadurch wurden Sponsorengespr\u00e4che und Vendor-Qualification-Pr\u00fcfungen deutlich einfacher und effizienter.\u201c<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b1f80a elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"9b1f80a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Danckert Mellbye<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aee0894 elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-heading\" data-id=\"aee0894\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Chief Operating Officer, Ledidi AS\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-de129ac e-flex e-con-boxed e-con e-parent\" data-id=\"de129ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-9f45285 e-con-full e-flex e-con e-child\" data-id=\"9f45285\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-57c00d5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"57c00d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Nutzung der Audit-Ergebnisse f\u00fcr die Lieferantenqualifizierung<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6b7c04 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d6b7c04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Die Audit-Ergebnisse k\u00f6nnen von Sponsoren und CROs im Rahmen der risikobasierten Supplier Qualification nach ISPE GAMP 5 genutzt werden.<\/p><p style=\"text-align: left;\"><strong>Wichtig:<\/strong><\/p><p style=\"text-align: left;\">Die Verantwortung f\u00fcr die Systemvalidierung und den bestimmungsgem\u00e4ssen Einsatz verbleibt jederzeit bei der regulierten Organisation.<\/p><p style=\"text-align: left;\">Ein GxP-Friendly Audit unterst\u00fctzt jedoch massgeblich bei:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Reduzierung von Qualifizierungsaufwand<\/li><li>Erh\u00f6hung der Transparenz gegen\u00fcber Sponsoren<\/li><li>Beschleunigung von Vertrags- und Auswahlprozessen<\/li><li>St\u00e4rkung der Compliance-Position<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5476352 e-flex e-con-boxed e-con e-parent\" data-id=\"5476352\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-33f016f e-con-full e-flex e-con e-child\" data-id=\"33f016f\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9826057 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"9826057\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warum sind GxP-Friendly Audits f\u00fcr SaaS-Anbieter strategisch wichtig?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c2a810c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"c2a810c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Cloud- und SaaS-L\u00f6sungen im Life-Sciences-Umfeld unterliegen besonderen regulatorischen Anforderungen.<\/p><p style=\"text-align: left;\"><strong>Herausforderungen sind u. a.:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Verantwortungsteilung zwischen Anbieter und regulierter Organisation<\/li><li>Validierung von cloudbasierten Systemen<\/li><li>Sicherstellung von Datenintegrit\u00e4t<\/li><li>Auditierbarkeit agiler Entwicklungsprozesse<\/li><li>regulatorische Erwartungen an elektronische Systeme<\/li><\/ul><p style=\"text-align: left;\"><strong>Ein unabh\u00e4ngiges GxP-Audit schafft hier:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>regulatorische Transparenz<\/li><li>Vertrauen bei Kunden<\/li><li>strukturierte Compliance-Nachweise<\/li><li>Wettbewerbsvorteile im regulierten Markt<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e4a4c11 e-flex e-con-boxed e-con e-parent\" data-id=\"e4a4c11\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-17e9917 e-con-full e-flex e-con e-child\" data-id=\"17e9917\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ad8f3ee elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"ad8f3ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Friendly Audit f\u00fcr SaaS-Anbieter im regulierten Umfeld<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2aca94e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"2aca94e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\">Planen Sie den Einsatz einer SaaS-L\u00f6sung in GxP-regulierten Prozessen? Oder m\u00f6chten Sie als Softwareanbieter Ihre regulatorische Reife strukturiert bewerten lassen?<\/p><p style=\"text-align: left;\"><strong>DHC Dr. Herterich &amp; Consultants unterst\u00fctzt Sie bei:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>GxP-Friendly Audits<\/li><li>Lieferantenqualifizierung (Supplier Qualification)<\/li><li>CSV- und CSA-Strategien<\/li><li>regulatorischen Bewertungen cloudbasierter Systeme<\/li><li>Compliance-Optimierung f\u00fcr digitale Plattformen<\/li><\/ul><div style=\"text-align: left;\">Mehr zu den DHC-Beratungsleistungen zur <a href=\"https:\/\/dhc.ima.vc\/audit-readiness\/\"><strong>Audit Readiness\u00a0<\/strong><span style=\"text-align: center; font-size: 17.3884px;\"><b>\u2192<\/b><\/span><\/a><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1aac793a e-flex e-con-boxed e-con e-child\" data-id=\"1aac793a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41223ab3 e-con-full e-flex e-con e-child\" data-id=\"41223ab3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1117cb89 e-con-full e-flex e-con e-child\" data-id=\"1117cb89\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7571e62 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"7571e62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Friendly Audit f\u00fcr SaaS-Anbieter im GxP-Umfeld<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fc7341d elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1fc7341d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Sie stehen vor einem Lieferanten-\/SaaS-Audit?<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b9cfc72 elementor-mobile-align-center custom-button elementor-widget elementor-widget-button\" data-id=\"4b9cfc72\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dhc.ima.vc\/termin-vereinbaren\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Jetzt unverbindliches 1:1-Expertengespr\u00e4ch vereinbaren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-293cbc43 e-con-full e-flex e-con e-child\" data-id=\"293cbc43\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68de9688 elementor-author-box--image-valign-middle elementor-widget elementor-widget-author-box\" data-id=\"68de9688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/valeria_ratter.jpg\" alt=\"Author picture\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-28880ae3 e-flex e-con-boxed e-con e-parent\" data-id=\"28880ae3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2a20d850 elementor-widget elementor-widget-heading\" data-id=\"2a20d850\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">FAQs<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18ce6bf5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"18ce6bf5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">H\u00e4ufige Fragen zu Friendly Audits f\u00fcr SaaS-Anbieter (FAQ)<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-44e5fd59 e-con-full e-flex e-con e-child\" data-id=\"44e5fd59\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7aa4d553 elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"7aa4d553\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2050\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2050\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Was ist ein \u201eGxP\u2011Friendly Audit\u201c f\u00fcr SaaS\u2011Plattformen \u2013 und wie unterscheidet es sich von einem klassischen Supplier-\/IT\u2011Audit? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2050\" class=\"elementor-element elementor-element-36557191 e-con-full e-flex e-con e-child\" data-id=\"36557191\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2050\" class=\"elementor-element elementor-element-463d48e e-flex e-con-boxed e-con e-child\" data-id=\"463d48e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-46a5d711 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"46a5d711\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ein GxP\u2011Friendly Audit ist ein risikobasiertes, SaaS\u2011taugliches Lieferanten-\/Plattform\u2011Audit, das gezielt die Controls pr\u00fcft, die f\u00fcr GxP\u2011Compliance und Auditierbarkeit entscheidend sind (z. B. Datenintegrit\u00e4t, Zugriffskontrollen, Change\/Release, Incident\/DR). Es ber\u00fccksichtigt dabei die Cloud-Realit\u00e4t (Multi\u2011Tenant, Standardprodukt, h\u00e4ufige Releases, begrenzte individuelle Audit\u2011Zug\u00e4nge).<\/p><p><strong>Unterschiede zum klassischen Audit:<\/strong><\/p><ul><li><strong>Shared Responsibility<\/strong> im Fokus: Klarer Zuschnitt, was der SaaS\u2011Provider verantwortet und was der Kunde organisatorisch\/prozessual sicherstellen muss.<\/li><li><strong>Evidenz pragmatisch<\/strong>: Nutzt realistische SaaS\u2011Nachweise (z. B. SOC\/ISO, Trust\u2011Center\u2011Artefakte) statt \u201eOn\u2011Prem\u201c-Artefakte zu erwarten, die SaaS oft nicht liefern kann.<\/li><li><strong>GxP\u2011Impact<\/strong> statt Vollabdeckung: Pr\u00fcft bevorzugt GxP\u2011kritische Bereiche statt \u201ealles, was theoretisch m\u00f6glich ist\u201c.<\/li><li><strong>Entscheidungsorientiert:<\/strong> Liefert eine Go\/No\u2011Go\u2011f\u00e4hige Bewertung inkl. Auflagen und Massnahmenplan.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2051\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2051\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche Regularien und Leitlinien adressiert ein GxP\u2011Friendly SaaS\u2011Audit typischerweise? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2051\" class=\"elementor-element elementor-element-30dabbe8 e-con-full e-flex e-con e-child\" data-id=\"30dabbe8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2051\" class=\"elementor-element elementor-element-419e22f6 e-flex e-con-boxed e-con e-child\" data-id=\"419e22f6\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5568af38 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"5568af38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ein GxP\u2011Friendly Audit \u201emapped\u201c die SaaS\u2011Controls typischerweise auf die regulatorischen Erwartungen rund um Computerized Systems und Datenintegrit\u00e4t. H\u00e4ufige Referenzen sind:<\/p><ul><li><strong>EU GMP inkl. Annex 11<\/strong>: Erwartungen an Betrieb, Sicherheit, Datenintegrit\u00e4t, Audit Trails, Lieferantensteuerung, Changes.<\/li><li><strong>GAMP 5<\/strong>: Leitlinie f\u00fcr risikobasiertes Vorgehen, Supplier Assessment, angemessene Verifikation\/Validierung.<\/li><li><strong>FDA 21 CFR Part 11<\/strong> (falls relevant): Anforderungen an elektronische Records und elektronische Signaturen.<\/li><li><strong>Data Integrity (ALCOA+)<\/strong> als Leitprinzip: Nachvollziehbarkeit, Vollst\u00e4ndigkeit, Unver\u00e4nderbarkeit, Verf\u00fcgbarkeit.<\/li><\/ul><p>Wichtig f\u00fcr Entscheider:<br \/>Nicht jede SaaS\u2011Nutzung ist automatisch \u201ePart\u201111\u2011kritisch\u201c. Relevanz h\u00e4ngt stark davon ab, ob die Plattform GxP\u2011Records erzeugt\/verwaltet und ob elektronische Signaturen eingesetzt werden.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2052\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2052\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche Pr\u00fcfschwerpunkte sind bei einem GxP\u2011Friendly Audit f\u00fcr SaaS am wichtigsten? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2052\" class=\"elementor-element elementor-element-2b933db4 e-con-full e-flex e-con e-child\" data-id=\"2b933db4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2052\" class=\"elementor-element elementor-element-77fefc68 e-flex e-con-boxed e-con e-child\" data-id=\"77fefc68\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8239be5 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"8239be5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Die wichtigsten Pr\u00fcfschwerpunkte sind die Controls, die direkt die Datenintegrit\u00e4t, Compliance\u2011Nachvollziehbarkeit und Betriebssicherheit beeinflussen:<\/p><p><strong>Audit Trail &amp; Datenintegrit\u00e4t<\/strong><\/p><ul><li>Ist der Audit Trail vollst\u00e4ndig (wer\/was\/wann\/warum), aktivierbar\/konfigurierbar, schutzf\u00e4hig und auswertbar?<\/li><li>K\u00f6nnen Records\/Audit Trails exportiert und f\u00fcr Audits langfristig genutzt werden<\/li><\/ul><p><strong>Identity &amp; Access Management (IAM)<\/strong><\/p><ul class=\"check-list\"><li>Rollen-\/Berechtigungskonzept (RBAC), Least Privilege, Admin\u2011Kontrollen<\/li><li>MFA\/SSO, User Lifecycle (Joiner\/Mover\/Leaver), Rezertifizierungen<\/li><\/ul><p><strong>Change- &amp; Release\u2011Management (SaaS\u2011Updatef\u00e4higkeit)<\/strong><\/p><ul><li>Wie werden Changes getestet, freigegeben und kommuniziert?<\/li><li>Gibt es Impact\u2011Bewertungen, Release Notes, ggf. Feature\u2011Toggles\/konfigurierbare Funktionen?<\/li><\/ul><p><strong>Backup\/Restore &amp; Business Continuity \/ Disaster Recovery<\/strong><\/p><ul><li>Definierte RPO\/RTO, Restore\u2011Tests, Nachweise \u00fcber DR\u2011\u00dcbungen<\/li><li>Verf\u00fcgbarkeit &amp; Wiederherstellbarkeit GxP\u2011kritischer Daten<\/li><\/ul><p><strong>Incident-, Problem- &amp; Vulnerability\u2011Management<\/strong><\/p><ul><li>Meldeprozesse, SLAs, RCA, CAPA\u2011Mechanismen<\/li><li>Patch\u2011\/Vulnerability\u2011Handling, Security Monitoring<\/li><\/ul><p>Erg\u00e4nzend oft entscheidend: Datenlokation\/Subprocessor\u2011Transparenz, Logging\/Monitoring, Schnittstellen &amp; Integrationen, Konfigurationskontrolle.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2053\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2053\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche Evidenzen\/Nachweise werden in einem GxP\u2011Friendly Audit f\u00fcr SaaS akzeptiert? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2053\" class=\"elementor-element elementor-element-6047a741 e-con-full e-flex e-con e-child\" data-id=\"6047a741\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2053\" class=\"elementor-element elementor-element-5b87de1e e-flex e-con-boxed e-con e-child\" data-id=\"5b87de1e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4f29af84 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4f29af84\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Akzeptierte Evidenzen sind typischerweise standardisierte, auditierte Nachweise und prozessuale Artefakte, die die Wirksamkeit der Controls belegen, z. B.:<\/p><ul><li><strong>SOC 2 Type II<\/strong> (inkl. Scope\/Zeitraum und getestete Controls)<\/li><li><strong>ISO 27001 Zertifizierung<\/strong> (plus relevante Anh\u00e4nge\/Scope, ggf. Statement of Applicability)<\/li><li><strong>Trust Center \/ Compliance Portal<\/strong> (Policies, Prozessbeschreibungen, Kontroll\u00fcbersichten)<\/li><li><strong>SDLC-\/Change\u2011Prozessnachweise<\/strong> (Release Notes, Change\u2011Workflows, Testzusammenfassungen)<\/li><li><strong>BCP\/DR\u2011Nachweise<\/strong> (DR\u2011Testberichte, Ergebnisse, Verbesserungsmassnahmen)<\/li><li><strong>Incident-\/Security\u2011Nachweise<\/strong> (Prozess, Ticket-\/RCA\u2011Beispiele in anonymisierter Form)<\/li><li><strong>Subprocessor\u2011Listen &amp; Data Processing Agreements (DPA)<\/strong>, Datenfluss-\/Architektur\u00fcbersichten<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2054\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2054\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Kann ein GxP\u2011Friendly Audit die Validierung (CSV\/CSA) ersetzen? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2054\" class=\"elementor-element elementor-element-4c981568 e-con-full e-flex e-con e-child\" data-id=\"4c981568\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2054\" class=\"elementor-element elementor-element-1e630a21 e-flex e-con-boxed e-con e-child\" data-id=\"1e630a21\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5153330f elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"5153330f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Ein GxP\u2011Friendly Audit ersetzt eine kundeninterne Validierung in der Regel nicht vollst\u00e4ndig, kann sie aber deutlich verschlanken und beschleunigen.<\/p><p>Was das Audit typischerweise leistet:<\/p><ul><li>Verifiziert die <strong>Provider\u2011Controls<\/strong> (z. B. Security, Ops, SDLC) als belastbare Basis f\u00fcr Supplier Qualification<\/li><li>Liefert Input f\u00fcr <strong>CSA\/CSV\u2011Scope<\/strong>: Was kann man als \u201eSupplier Evidence\u201c \u00fcbernehmen, was muss der Kunde selbst testen?<\/li><li>Erstellt eine <strong>Shared Responsibility Matrix<\/strong>, die klare Kundenmassnahmen ableitet (SOPs, Rollenmodell, Periodic Review, Konfigurationskontrolle)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-643854bd e-flex e-con-boxed e-con e-parent\" data-id=\"643854bd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fd289b3 elementor-widget elementor-widget-heading\" data-id=\"4fd289b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Magazin<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52106f4c elementor-widget elementor-widget-heading\" data-id=\"52106f4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Weitere Artikel aus dem Blog<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25940306 elementor-grid-tablet-1 elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"25940306\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:2842,&quot;columns_tablet&quot;:1,&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-loop-container elementor-grid\">\n\t\t<style id=\"loop-2842\">.elementor-2842 .elementor-element.elementor-element-adf3d07{--display:flex;--justify-content:space-between;--gap:20px 20px;--row-gap:20px;--column-gap:20px;border-style:solid;--border-style:solid;border-width:1px 1px 1px 1px;--border-top-width:1px;--border-right-width:1px;--border-bottom-width:1px;--border-left-width:1px;border-color:#44444444;--border-color:#44444444;--border-radius:20px 20px 20px 20px;--margin-top:0px;--margin-bottom:0px;--margin-left:0px;--margin-right:0px;--padding-top:20px;--padding-bottom:30px;--padding-left:20px;--padding-right:20px;--e-con-transform-origin-x:center;--e-con-transform-origin-y:center;}.elementor-2842 .elementor-element.elementor-element-adf3d07:hover{border-style:solid;border-width:1px 1px 1px 1px;--border-top-width:1px;--border-right-width:1px;--border-bottom-width:1px;--border-left-width:1px;border-color:var( --e-global-color-accent );--border-color:var( --e-global-color-accent );}.elementor-2842 .elementor-element.elementor-element-adf3d07, .elementor-2842 .elementor-element.elementor-element-adf3d07::before{--border-transition:0.3s;}.elementor-2842 .elementor-element.elementor-element-adf3d07.e-con:hover{--e-con-transform-scale:1.03;}.elementor-widget-theme-post-title .elementor-heading-title{font-family:var( --e-global-typography-primary-font-family ), Sans-serif;font-size:var( --e-global-typography-primary-font-size );font-weight:var( --e-global-typography-primary-font-weight );color:var( --e-global-color-primary );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-family:var( --e-global-typography-0dec4fd-font-family ), Sans-serif;font-size:var( --e-global-typography-0dec4fd-font-size );font-weight:var( --e-global-typography-0dec4fd-font-weight );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}.elementor-widget-theme-post-excerpt{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );color:var( --e-global-color-text );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-family:var( --e-global-typography-text-font-family ), Sans-serif;font-size:var( --e-global-typography-text-font-size );font-weight:var( --e-global-typography-text-font-weight );line-height:var( --e-global-typography-text-line-height );margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}.elementor-widget-icon.elementor-view-stacked .elementor-icon{background-color:var( --e-global-color-primary );}.elementor-widget-icon.elementor-view-framed .elementor-icon, .elementor-widget-icon.elementor-view-default .elementor-icon{color:var( --e-global-color-primary );border-color:var( --e-global-color-primary );}.elementor-widget-icon.elementor-view-framed .elementor-icon, .elementor-widget-icon.elementor-view-default .elementor-icon svg{fill:var( --e-global-color-primary );}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon-wrapper{text-align:center;}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon{font-size:54px;}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon svg{height:54px;}.elementor-2842 .elementor-element.elementor-element-2511066{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}@media(max-width:1024px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--justify-content:space-evenly;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}@media(min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:1024px) and (min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:767px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--min-height:0px;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}\/* Start custom CSS for container, class: .elementor-element-adf3d07 *\/.elementor-2842 .elementor-element.elementor-element-adf3d07{\n    position: relative;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .icon-more-posts{\n    position: absolute;\n    bottom: 20px;\n    left: 0;\n    right: 0;\n    opacity: 0;\n    transform: translateY(8px);\n    transition: opacity 0.3s ease, transform 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .icon-more-posts{\n    opacity: 1;\n    transform: translateY(0);\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .loop-post-excerpt{\n    padding-bottom: 0;\n    transition: padding-bottom 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .loop-post-excerpt{\n    padding-bottom: 70px;\n}\/* End custom CSS *\/<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-16122 post-16122 post type-post status-publish format-standard has-post-thumbnail hentry category-gxp-compliance-csv tag-cloud-validierung tag-public-cloud-validierung\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/ch\/sap-innovation-trifft-gxp-compliance\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SAP-Innovation trifft auf GxP-Compliance<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tWie ver\u00e4ndern Cloud, SaaS, AI &amp; h\u00e4ufige Releases die Validierung?\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-12543 post-12543 post type-post status-publish format-standard has-post-thumbnail hentry category-sap-qualitaetsmanagement tag-qm-mit-sap tag-sap-qim tag-sap-qm\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/ch\/sap-qim-support-ende-und-abloesung\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SAP QIM Support-Ende 2027: Warum Unternehmen jetzt handeln sollten<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tSAP QIM Support endet 2027: Erfahren Sie, welche Risiken entstehen und warum sich eine fr\u00fchzeitige Migration zu QM in S\/4HANA\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-12545 post-12545 post type-post status-publish format-standard has-post-thumbnail hentry category-gxp-compliance-csv\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tIm Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits wurde die SaaS-Plattform Ledidi Trials durch DHC umfassend bewertet.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits wurde die SaaS-Plattform Ledidi Trials durch DHC umfassend bewertet. <\/p>\n","protected":false},"author":2,"featured_media":15564,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[99],"tags":[],"class_list":["post-12545","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gxp-compliance-csv"],"acf":[],"yoast_title":"GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)","yoast_metadesc":"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat","elementor_data":[{"id":"f897850","elType":"container","settings":{"flex_direction":"column","flex_gap":{"column":"0","row":"0","isLinked":true,"unit":"px","size":0},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"width_tablet":{"unit":"%","size":"","sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"boxed_width":{"unit":"px","size":1336,"sizes":[]},"flex_align_items":"center","_flex_align_self":"center","_flex_size":"grow"},"elements":[{"id":"ae80faa","elType":"container","settings":{"flex_direction":"column","background_background":"classic","background_image":{"url":"","id":"","size":"","alt":"","source":"library"},"margin":{"unit":"px","top":"0","right":"0","bottom":"30","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"width":{"unit":"%","size":98,"sizes":[]},"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"_title":"Keyvisual","margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"background_image_mobile":{"url":"","id":"","size":"","alt":"","source":"library"},"background_position_mobile":"bottom left","background_size_mobile":"cover","boxed_width":{"unit":"px","size":1336,"sizes":[]},"flex_align_items":"center"},"elements":[{"id":"21d8f3a","elType":"container","settings":{"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","background_image":{"id":14180,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/unterseite_keyvisual.webp","alt":"","source":"library","size":""},"background_position":"bottom center","background_repeat":"no-repeat","background_size":"cover","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_title":"Background","boxed_width":{"unit":"px","size":1366,"sizes":[]},"padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"z_index":0,"width":{"unit":"%","size":100,"sizes":[]},"content_width":"full","min_height":{"unit":"px","size":220,"sizes":[]},"border_radius":{"unit":"px","top":"0","right":"0","bottom":"20","left":"20","isLinked":false},"_flex_size":"grow","min_height_tablet":{"unit":"px","size":200,"sizes":[]},"background_position_tablet":"center center","background_image_mobile":{"url":"","id":"","size":"","alt":"","source":"library"},"background_position_mobile":"bottom right","min_height_mobile":{"unit":"px","size":150,"sizes":[]}},"elements":[],"isInner":true}],"isInner":true}],"isInner":false},{"id":"2f1a1d65","elType":"container","settings":{"flex_direction":"row","flex_gap":{"unit":"px","size":20,"column":"20","row":"0"},"flex_align_items":"stretch","margin":{"unit":"px","top":"0","right":"0","bottom":"20","left":"0","isLinked":false},"flex_direction_tablet":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false}},"elements":[{"id":"8b07514","elType":"container","settings":{"flex_direction":"column","content_width":"full","width":{"unit":"%","size":"50"},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"5e177196","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"40","right":"32","bottom":"40","left":"32","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"020","bottom":"30","left":"020","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false},"min_height":{"unit":"custom","size":"100%","sizes":[]},"min_height_tablet":{"unit":"custom","size":"","sizes":[]},"min_height_mobile":{"unit":"custom","size":"","sizes":[]},"flex_justify_content":"space-around"},"elements":[{"id":"2749cd7f","elType":"widget","settings":{"__dynamic__":{"title":"[elementor-tag id=\"\" name=\"post-title\" settings=\"%7B%22before%22%3A%22%22%2C%22after%22%3A%22%22%2C%22fallback%22%3A%22%22%7D\"]"},"title":"Geben Sie hier Ihre \u00dcberschrift ein","typography_typography":"custom","typography_font_family":"Poppins","typography_font_size":{"unit":"px","size":28,"sizes":[]},"typography_font_weight":"500"},"elements":[],"widgetType":"theme-post-title"},{"id":"7755013d","elType":"widget","settings":{"editor":"<div data-testid=\"markdown-response\"><p id=\"message\">Im Rahmen eines unabh\u00e4ngigen <strong>GxP-Friendly Audits<\/strong> wurde die <strong>SaaS-Plattform\u00a0Ledidi\u00a0Trials<\/strong> durch DHC umfassend bewertet. Ziel war die strukturierte, transparente und risikobasierte Beurteilung der regulatorischen Eignung f\u00fcr den Einsatz in GxP-regulierten klinischen Studien.<\/p><\/div>","__globals__":{"typography_typography":"globals\/typography?id=538daf9","text_color":""}},"elements":[],"widgetType":"text-editor"},{"id":"17a14cbf","elType":"widget","settings":{"source":"custom","author_avatar":{"id":5872,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/Thomas-Pauly.webp","alt":"","source":"library","size":""},"show_name":"","author_name":"Thomas Pauly, Practice Manager, DHC GmbH","show_biography":"","author_bio":"","link_text":"All Posts","alignment":"left","image_size":{"unit":"px","size":70,"sizes":[]},"image_gap":{"unit":"px","size":12,"sizes":[]},"image_border_width":{"unit":"px","size":5,"sizes":[]},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_border_border":"none","_border_width":{"unit":"px","top":"5","right":"5","bottom":"5","left":"5","isLinked":true},"__globals__":{"_border_color":"globals\/colors?id=primary","image_border_color":""},"image_size_mobile":{"unit":"px","size":55,"sizes":[]},"author_name_tag":"div","image_border_color":"#FEFEFE","_border_color":"#0C693F","name_typography_typography":"custom","name_typography_font_family":"Poppins","name_typography_font_size":{"unit":"px","size":18,"sizes":[]},"name_typography_font_weight":"600","layout":"left"},"elements":[],"widgetType":"author-box"}],"isInner":true}],"isInner":true},{"id":"6194c5a2","elType":"container","settings":{"flex_direction":"column","content_width":"full","width":{"unit":"%","size":"50"},"min_height":{"unit":"custom","size":"100%","sizes":[]},"min_height_tablet":{"unit":"custom","size":"","sizes":[]},"min_height_mobile":{"unit":"custom","size":"","sizes":[]},"flex_justify_content":"space-between","width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"30","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"571a5a01","elType":"widget","settings":{"__dynamic__":{"image":"[elementor-tag id=\"\" name=\"post-featured-image\" settings=\"%7B%22fallback%22%3A%7B%22url%22%3A%22https%3A%2F%2Fdhc.ima.vc%2Fwp-content%2Fuploads%2F2026%2F03%2Fdiscovery-phase-sap-transformation-systemlandschaft-analyse.webp%22%2C%22id%22%3A5421%2C%22size%22%3A%22%22%2C%22alt%22%3A%22SAP%20Discovery-Phase%20mit%20Analyse%20der%20bestehenden%20Systemlandschaft%20und%20Integrationen%22%2C%22source%22%3A%22library%22%7D%7D\"]"},"image_size":"full","width":{"unit":"%","size":100,"sizes":[]},"space":{"unit":"%","size":100,"sizes":[]},"height":{"unit":"px","size":500,"sizes":[]},"height_tablet":{"unit":"px","size":350,"sizes":[]},"height_mobile":{"unit":"px","size":250,"sizes":[]},"object-fit":"cover","object-fit_tablet":"cover","object-position_tablet":"center center","image_border_radius":{"unit":"px","top":"30","right":"30","bottom":"30","left":"30","isLinked":true},"caption_typography_line_height":{"unit":"em","size":"","sizes":[]},"caption_typography_word_spacing":{"unit":"em","size":"","sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_background_gradient_position_tablet":"center center","_background_gradient_position_mobile":"center center","_background_hover_gradient_position_tablet":"center center","_background_hover_gradient_position_mobile":"center center","image":{"id":2618,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/12\/placeholder-1.png"}},"elements":[],"widgetType":"theme-post-featured-image"}],"isInner":true}],"isInner":false},{"id":"49e17216","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"7989692a","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"4ab08e4a","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Der Beitrag zeigt, wie sich die Audit-Ergebnisse als Supplier Evidence f\u00fcr eine <strong>risikobasierte Lieferantenqualifizierung<\/strong> nutzen lassen \u2013 und dass das Audit die kundeninterne <a href=\"https:\/\/dhc.ima.vc\/softwarevalidierung\/\"><strong>Validierung (CSV\/CSA)<\/strong><\/a>\u00a0nicht ersetzt, sie aber typischerweise deutlich beschleunigt und verschlankt.<\/p><p style=\"text-align: left;\">Die regulatorische Bewertung von SaaS-Plattformen, die f\u00fcr\u00a0GxP-relevante Prozesse eingesetzt werden\u00a0sollen, sind von hoher Bedeutung. Insbesondere bei cloudbasierten L\u00f6sungen stehen Themen wie Datenintegrit\u00e4t, elektronische Signaturen, IT-Sicherheit und Lieferantenqualifizierung im Fokus.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"f944eeb","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"2871744","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"49ea18a","elType":"widget","settings":{"title":"Was ist ein GxP\u00a0Friendly Audit?","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"41fe603","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Ein GxP\u00a0Friendly Audit ist ein <strong>unabh\u00e4ngiges, vorbereitendes Audit ohne formale Inspektionsfunktion<\/strong>.<\/p><p style=\"text-align: left;\"><strong>Es dient der:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Bewertung der regulatorischen Reife eines Systems oder SaaS-Anbieters<\/li><li>Identifikation m\u00f6glicher Compliance-Risiken und - optional \u2013 Aufzeigen von Handlungsempfehlungen<\/li><li>Unterst\u00fctzung der risikobasierten Lieferantenqualifizierung (Supplier Qualification)<\/li><li>Vorbereitung auf Kundenaudits oder Beh\u00f6rdeninspektionen<\/li><\/ul><p style=\"text-align: left;\">Im Gegensatz zu klassischen Lieferantenaudits steht hier die\u00a0unterst\u00fctzende, strukturierte Analyse der\u00a0GxP-Readiness\u00a0im Vordergrund.<\/p><p style=\"text-align: left;\">Gerade f\u00fcr SaaS-Anbieter im regulierten Umfeld ist ein Friendly Audit ein strategisches Instrument\u00a0in Hinblick auf die GxP Compliance.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"start","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"4abd488","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"b97ffdf","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"26e241f","elType":"widget","settings":{"title":"\u00dcber Ledidi Trials","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"655cda3","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\"><a href=\"https:\/\/ledidi.com\/platform\/features\/platform-features-trials-module\" target=\"_blank\" rel=\"noopener\"><img class=\"alignright wp-image-11372 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/ledidi.webp\" alt=\"Logo von Ledidi, Anbieter von Software f\u00fcr klinische Daten und Forschung\" width=\"300\" height=\"157\" \/><\/a>Ledidi\u00a0ist ein Technologieunternehmen mit Fokus auf digitale L\u00f6sungen f\u00fcr datengetriebene klinische Forschung. Ziel ist es, Sponsoren, CROs und Studienteams durch moderne Softwareans\u00e4tze eine effizientere Studienplanung, -durchf\u00fchrung und -auswertung zu erm\u00f6glichen.<\/p><p style=\"text-align: left;\">Mit\u00a0Ledidi\u00a0Trials bietet das Unternehmen eine <strong>SaaS-basierte Plattform zur Unterst\u00fctzung klinischer Studienprozesse<\/strong>. Schwerpunkte sind:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>strukturierte Datenverarbeitung<\/li><li>kollaborative Arbeitsprozesse<\/li><li>Transparenz zwischen Studienbeteiligten<\/li><li>digitale Unterst\u00fctzung regulatorischer Anforderungen<\/li><\/ul><p style=\"text-align: left;\">Die L\u00f6sung ist f\u00fcr den Einsatz in regulierten klinischen Forschungsumgebungen konzipiert und wird kontinuierlich weiterentwickelt, um aktuellen regulatorischen und industriellen Anforderungen gerecht zu werden.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"3b052d1","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"86dc434","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"07124c9","elType":"widget","settings":{"title":"Auditansatz und regulatorischer Rahmen","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"1fcd44c","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Das Audit wurde als unabh\u00e4ngiges, risikobasiertes GxP-Friendly Audit durchgef\u00fchrt und orientierte sich an internationalen regulatorischen Anforderungen und Leitlinien, darunter:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>FDA 21 CFR Part 11 (Elektronische Aufzeichnungen und elektronische Signaturen)<\/li><li>ICH GCP E6(R3)<\/li><li>ISPE GAMP 5 (risikobasierter Ansatz f\u00fcr computergest\u00fctzte Systeme)<\/li><\/ul><p style=\"text-align: left;\">Der Fokus lag auf einer lieferantenseitigen Bewertung der:<\/p><ul class=\"check-list\"><li style=\"text-align: left;\">Angemessenheit des Qualit\u00e4tsmanagementsystems<\/li><li style=\"text-align: left;\">Wirksamkeit der Entwicklungs- und Kontrollmechanismen<\/li><li style=\"text-align: left;\">Eignung der Betriebsprozesse<\/li><li style=\"text-align: left;\">Eignung f\u00fcr den Einsatz in GxP-regulierten klinischen Studien<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"a186792","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"2a6a54a","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"64385fb","elType":"widget","settings":{"title":"Umfang des GxP-Audits f\u00fcr die SaaS-Plattform","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"9de4a88","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Das Audit umfasste folgende zentrale Pr\u00fcfbereiche:<\/p><p style=\"text-align: left;\"><strong>Qualit\u00e4tsmanagementsystem (QMS)<\/strong><\/p><ul style=\"text-align: left;\"><li>Struktur und Dokumentation<\/li><li>Rollen- und Verantwortlichkeitsmodelle<\/li><li>CAPA- und \u00c4nderungsmanagement<\/li><\/ul><p style=\"text-align: left;\"><strong>Software Development Lifecycle (SDLC)<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Entwicklungsprozesse<\/li><li>agile Methoden und Dokumentation<\/li><li>Traceability\u00a0und Nachvollziehbarkeit<\/li><\/ul><p style=\"text-align: left;\"><strong>Release- und Change-Management<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>formalisierte Freigabeprozesse<\/li><li>kontrollierte Versionsverwaltung<\/li><li>Impact- und Risikoanalysen<\/li><\/ul><p style=\"text-align: left;\"><strong>SaaS-Betrieb und IT-Sicherheit<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Zugriffskontrollen<\/li><li>rollenbasierte Berechtigungen<\/li><li>elektronische Signaturen<\/li><li>Datensicherheitsmassnahmen<\/li><\/ul><p style=\"text-align: left;\"><strong>Datenintegrit\u00e4t und Business Continuity<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Backup-Strategien<\/li><li>Disaster Recovery<\/li><li>Business Continuity Management<\/li><li>Audit Trails<\/li><li>Sicherstellung\u00a0von ALCOA+-Prinzipien<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"4d5792e","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"84118aa","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"3882fbe","elType":"widget","settings":{"title":"Ergebnis des Audits","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"80391f8","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Das unabh\u00e4ngige\u00a0Friendly\u00a0Audit best\u00e4tigte, dass\u00a0Ledidi\u00a0Trials ein <strong>umfassendes und strukturiertes\u00a0Qualit\u00e4tssystem<\/strong> implementiert hat.<\/p><p style=\"text-align: left;\">Der abschliessende Auditbericht enth\u00e4lt <strong>keine offenen Abweichungen<\/strong> und best\u00e4tigt die grunds\u00e4tzliche Einsatzbereitschaft der Plattform f\u00fcr\u00a0GxP-regulierte klinische Studien.<\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"e86d2a2","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"ffbb15e","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"85b56d1","elType":"widget","settings":{"selected_icon":{"value":"fas fa-quote-left","library":"fa-solid"},"align":"start","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"_flex_align_self":"center"},"elements":[],"widgetType":"icon"},{"id":"4611133","elType":"widget","settings":{"editor":"<p><em>\u201eDas Friendly Audit von DHC und der daraus resultierende Bericht lieferten uns inspektionsbereite Nachweise zu elektronischen Aufzeichnungen und Signaturen, Audit Trails sowie R\u00fcckverfolgbarkeit \u2013 ausgerichtet an anerkannten regulatorischen Erwartungen. Dadurch wurden Sponsorengespr\u00e4che und Vendor-Qualification-Pr\u00fcfungen deutlich einfacher und effizienter.\u201c<\/em><\/p>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=text","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"_background_color_stop_tablet":{"unit":"%"},"_background_color_stop_mobile":{"unit":"%"},"_background_color_b_stop_tablet":{"unit":"%"},"_background_color_b_stop_mobile":{"unit":"%"},"_background_gradient_angle_tablet":{"unit":"deg"},"_background_gradient_angle_mobile":{"unit":"deg"},"_background_hover_color_stop_tablet":{"unit":"%"},"_background_hover_color_stop_mobile":{"unit":"%"},"_background_hover_color_b_stop_tablet":{"unit":"%"},"_background_hover_color_b_stop_mobile":{"unit":"%"},"_background_hover_gradient_angle_tablet":{"unit":"deg"},"_background_hover_gradient_angle_mobile":{"unit":"deg"},"_flex_size":"none","_flex_align_self":"center"},"elements":[],"widgetType":"text-editor"},{"id":"9b1f80a","elType":"widget","settings":{"title":"Danckert Mellbye","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=538daf9","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":90,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"header_size":"div","_element_width_mobile":"inherit","_background_color_stop_tablet":{"unit":"%"},"_background_color_stop_mobile":{"unit":"%"},"_background_color_b_stop_tablet":{"unit":"%"},"_background_color_b_stop_mobile":{"unit":"%"},"_background_gradient_angle_tablet":{"unit":"deg"},"_background_gradient_angle_mobile":{"unit":"deg"},"_background_hover_color_stop_tablet":{"unit":"%"},"_background_hover_color_stop_mobile":{"unit":"%"},"_background_hover_color_b_stop_tablet":{"unit":"%"},"_background_hover_color_b_stop_mobile":{"unit":"%"},"_background_hover_gradient_angle_tablet":{"unit":"deg"},"_background_hover_gradient_angle_mobile":{"unit":"deg"},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"aee0894","elType":"widget","settings":{"title":"Chief Operating Officer, Ledidi AS\n","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=e6d4d63","title_color":"globals\/colors?id=text"},"_element_custom_width_mobile":{"unit":"%","size":90,"sizes":[]},"title_color":"#444444","header_size":"div","_element_width_mobile":"inherit","_background_color_stop_tablet":{"unit":"%"},"_background_color_stop_mobile":{"unit":"%"},"_background_color_b_stop_tablet":{"unit":"%"},"_background_color_b_stop_mobile":{"unit":"%"},"_background_gradient_angle_tablet":{"unit":"deg"},"_background_gradient_angle_mobile":{"unit":"deg"},"_background_hover_color_stop_tablet":{"unit":"%"},"_background_hover_color_stop_mobile":{"unit":"%"},"_background_hover_color_b_stop_tablet":{"unit":"%"},"_background_hover_color_b_stop_mobile":{"unit":"%"},"_background_hover_gradient_angle_tablet":{"unit":"deg"},"_background_hover_gradient_angle_mobile":{"unit":"deg"},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"}],"isInner":true}],"isInner":false},{"id":"de129ac","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"9f45285","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"57c00d5","elType":"widget","settings":{"title":"Nutzung der Audit-Ergebnisse f\u00fcr die Lieferantenqualifizierung","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"d6b7c04","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Die Audit-Ergebnisse k\u00f6nnen von Sponsoren und CROs im Rahmen der risikobasierten Supplier Qualification nach ISPE GAMP 5 genutzt werden.<\/p><p style=\"text-align: left;\"><strong>Wichtig:<\/strong><\/p><p style=\"text-align: left;\">Die Verantwortung f\u00fcr die Systemvalidierung und den bestimmungsgem\u00e4ssen Einsatz verbleibt jederzeit bei der regulierten Organisation.<\/p><p style=\"text-align: left;\">Ein GxP-Friendly Audit unterst\u00fctzt jedoch massgeblich bei:<\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Reduzierung von Qualifizierungsaufwand<\/li><li>Erh\u00f6hung der Transparenz gegen\u00fcber Sponsoren<\/li><li>Beschleunigung von Vertrags- und Auswahlprozessen<\/li><li>St\u00e4rkung der Compliance-Position<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"5476352","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"33f016f","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"9826057","elType":"widget","settings":{"title":"Warum sind GxP-Friendly Audits f\u00fcr SaaS-Anbieter strategisch wichtig?","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"c2a810c","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Cloud- und SaaS-L\u00f6sungen im Life-Sciences-Umfeld unterliegen besonderen regulatorischen Anforderungen.<\/p><p style=\"text-align: left;\"><strong>Herausforderungen sind u. a.:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>Verantwortungsteilung zwischen Anbieter und regulierter Organisation<\/li><li>Validierung von cloudbasierten Systemen<\/li><li>Sicherstellung von Datenintegrit\u00e4t<\/li><li>Auditierbarkeit agiler Entwicklungsprozesse<\/li><li>regulatorische Erwartungen an elektronische Systeme<\/li><\/ul><p style=\"text-align: left;\"><strong>Ein unabh\u00e4ngiges GxP-Audit schafft hier:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>regulatorische Transparenz<\/li><li>Vertrauen bei Kunden<\/li><li>strukturierte Compliance-Nachweise<\/li><li>Wettbewerbsvorteile im regulierten Markt<\/li><\/ul>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"e4a4c11","elType":"container","settings":{"flex_direction":"column","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"flex_direction_tablet":"column","_title":"Text","margin":{"unit":"px","top":"0","right":"0","bottom":"100","left":"0","isLinked":false},"margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"17e9917","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"80","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"},"flex_gap":{"column":"0","row":"20","isLinked":false,"unit":"px","size":0},"border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"width_tablet":{"unit":"%","size":100,"sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"padding_tablet":{"unit":"px","top":"50","right":"40","bottom":"50","left":"40","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false}},"elements":[{"id":"ad8f3ee","elType":"widget","settings":{"title":"Friendly Audit f\u00fcr SaaS-Anbieter im regulierten Umfeld","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a","title_color":"globals\/colors?id=secondary"},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"align":"center","_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"2aca94e","elType":"widget","settings":{"editor":"<p style=\"text-align: left;\">Planen Sie den Einsatz einer SaaS-L\u00f6sung in GxP-regulierten Prozessen? Oder m\u00f6chten Sie als Softwareanbieter Ihre regulatorische Reife strukturiert bewerten lassen?<\/p><p style=\"text-align: left;\"><strong>DHC Dr. Herterich &amp; Consultants unterst\u00fctzt Sie bei:<\/strong><\/p><ul class=\"check-list\" style=\"text-align: left;\"><li>GxP-Friendly Audits<\/li><li>Lieferantenqualifizierung (Supplier Qualification)<\/li><li>CSV- und CSA-Strategien<\/li><li>regulatorischen Bewertungen cloudbasierter Systeme<\/li><li>Compliance-Optimierung f\u00fcr digitale Plattformen<\/li><\/ul><div style=\"text-align: left;\">Mehr zu den DHC-Beratungsleistungen zur <a href=\"https:\/\/dhc.ima.vc\/audit-readiness\/\"><strong>Audit Readiness\u00a0<\/strong><span style=\"text-align: center; font-size: 17.3884px;\"><b>\u2192<\/b><\/span><\/a><\/div>","_element_width":"initial","_element_custom_width":{"unit":"%","size":85,"sizes":[]},"__globals__":{"link_color":"globals\/colors?id=text","typography_typography":"globals\/typography?id=538daf9","link_hover_color":"globals\/colors?id=accent"},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"link_hover_color_transition_duration":{"unit":"s","size":0.3,"sizes":[]},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"align":"center","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"1aac793a","elType":"container","settings":{"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"__globals__":{"background_overlay_color":"globals\/colors?id=aaddc3b","background_color":"globals\/colors?id=9b310c9"},"margin":{"unit":"px","top":"-60","right":"0","bottom":"0","left":"0","isLinked":false},"_title":"CTA","margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"41223ab3","elType":"container","settings":{"flex_direction":"row","boxed_width":{"unit":"px","size":1280,"sizes":[]},"flex_justify_content":"space-evenly","flex_align_items":"center","background_background":"classic","background_image":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/achivements_background.webp","id":14191,"size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"50","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false},"content_width":"full","width":{"unit":"%","size":100},"padding_tablet":{"unit":"px","top":"40","right":"20","bottom":"40","left":"20","isLinked":false},"_element_width_none":"initial","width_none":{"size":681.6},"_element_width":"initial","flex_gap":{"column":"20","row":"0","isLinked":false,"unit":"px","size":20},"background_position":"center center","background_size":"cover","border_radius":{"unit":"px","top":"20","right":"20","bottom":"20","left":"20","isLinked":true},"__globals__":{"background_color":""},"flex_direction_tablet":"row","background_position_mobile":"center center","margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true}},"elements":[{"id":"1117cb89","elType":"container","settings":{"flex_direction":"column","boxed_width":{"unit":"px","size":1280,"sizes":[]},"background_background":"classic","background_image":{"url":"","id":"","size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"content_width":"full","width":{"unit":"%","size":70},"padding_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":true},"_flex_size":"none","_element_width_none":"initial","width_none":{"size":681.6},"_element_width":"initial","flex_gap":{"column":"10","row":"10","isLinked":false,"unit":"px","size":10},"_flex_align_self":"center","width_mobile":{"unit":"%","size":"","sizes":[]},"flex_gap_mobile":{"column":"15","row":"15","isLinked":true,"unit":"px","size":15},"flex_gap_tablet":{"column":"15","row":"15","isLinked":true,"unit":"px","size":15}},"elements":[{"id":"7571e62","elType":"widget","settings":{"title":"Friendly Audit f\u00fcr SaaS-Anbieter im GxP-Umfeld","align":"start","_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"10","left":"0","isLinked":false},"_element_width":"inherit","_element_custom_width":{"unit":"%","size":91,"sizes":[]},"__globals__":{"typography_typography":""},"_element_custom_width_tablet":{"unit":"%","size":80,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"_padding_mobile":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"_flex_size":"none","_element_width_none":"initial","_element_custom_width_none":{"size":491.025},"align_mobile":"center","typography_typography":"custom","typography_font_family":"Poppins","typography_font_size":{"unit":"custom","size":"clamp(1.125rem, 0.6389rem + 1.5556vw, 2rem)","sizes":[]},"typography_font_weight":"400","typography_line_height":{"unit":"custom","size":"120%","sizes":[]},"typography_line_height_mobile":{"unit":"custom","size":"120%","sizes":[]}},"elements":[],"widgetType":"heading"},{"id":"1fc7341d","elType":"widget","settings":{"editor":"<p>Sie stehen vor einem Lieferanten-\/SaaS-Audit?<\/p>","__globals__":{"typography_typography":"globals\/typography?id=text"},"align":"start","_element_width":"initial","_element_custom_width":{"unit":"%","size":80,"sizes":[]},"align_mobile":"center","_element_width_mobile":"inherit","_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"paragraph_spacing":{"unit":"px","size":0,"sizes":[]}},"elements":[],"widgetType":"text-editor"},{"id":"4b9cfc72","elType":"widget","settings":{"text":"Jetzt unverbindliches 1:1-Expertengespr\u00e4ch vereinbaren","border_border":"solid","border_width":{"unit":"px","top":"1","right":"1","bottom":"1","left":"1","isLinked":true},"__globals__":{"button_background_hover_color":"globals\/colors?id=9b310c9","hover_color":"globals\/colors?id=accent","border_color":"globals\/colors?id=accent"},"link":{"url":"https:\/\/dhc.ima.vc\/termin-vereinbaren\/","is_external":"","nofollow":"","custom_attributes":""},"button_text_color":"#FFFFFF","selected_icon":{"value":"fas fa-arrow-right","library":"fa-solid"},"icon_align":"row-reverse","icon_indent":{"unit":"px","size":19,"sizes":[]},"align_mobile":"center","_flex_align_self":"flex-start","_flex_align_self_mobile":"center","_css_classes":"custom-button"},"elements":[],"widgetType":"button"}],"isInner":true},{"id":"293cbc43","elType":"container","settings":{"flex_direction":"column","boxed_width":{"unit":"px","size":1280,"sizes":[]},"flex_align_items":"center","background_background":"classic","background_image":{"url":"","id":"","size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"content_width":"full","width":{"unit":"custom","size":"fit-content","sizes":[]},"width_tablet":{"unit":"custom","size":"","sizes":[]},"width_mobile":{"unit":"%","size":"","sizes":[]},"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"boxed_width_mobile":{"unit":"px","size":0,"sizes":[]},"flex_direction_mobile":"column-reverse","_flex_order_mobile":"start"},"elements":[{"id":"68de9688","elType":"widget","settings":{"source":"custom","author_avatar":{"id":15188,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/valeria_ratter.jpg","alt":"","source":"library","size":""},"show_name":"","author_name":"","show_biography":"","show_link":"","author_bio":"","link_text":"Alle Beitr\u00e4ge","image_size":{"unit":"px","size":170,"sizes":[]},"image_gap":{"unit":"px","size":0,"sizes":[]},"image_border_color":"#FFFFFF","image_border_width":{"unit":"px","size":15,"sizes":[]},"image_border_radius":{"unit":"px","size":100,"sizes":[]},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_z_index":5,"_offset_x":{"size":55,"unit":"px"},"image_size_mobile":{"unit":"px","size":80,"sizes":[]},"_offset_y":{"size":0,"unit":"px"},"_title":"Autor Box","image_vertical_align":"middle","image_size_tablet":{"unit":"px","size":140,"sizes":[]},"image_gap_mobile":{"unit":"px","size":0,"sizes":[]},"button_text_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[],"widgetType":"author-box"}],"isInner":true}],"isInner":true}],"isInner":true},{"id":"28880ae3","elType":"container","settings":{"flex_direction":"column","margin":{"unit":"px","top":"0","right":"0","bottom":"120","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"_title":"FAQ","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false}},"elements":[{"id":"2a20d850","elType":"widget","settings":{"title":"FAQs","align":"center","_padding":{"unit":"px","top":"10","right":"20","bottom":"10","left":"20","isLinked":false},"_flex_align_self":"center","_background_background":"gradient","_background_color_b":"","_border_radius":{"unit":"px","top":"50","right":"50","bottom":"50","left":"50","isLinked":true},"__globals__":{"typography_typography":"globals\/typography?id=secondary","title_color":"globals\/colors?id=9b310c9","_background_color":"globals\/colors?id=accent"},"header_size":"div","_margin":{"unit":"px","top":"40","right":"0","bottom":"15","left":"0","isLinked":false}},"elements":[],"widgetType":"heading"},{"id":"18ce6bf5","elType":"widget","settings":{"title":"H\u00e4ufige Fragen zu Friendly Audits f\u00fcr SaaS-Anbieter (FAQ)","align":"center","_element_width":"initial","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_flex_align_self":"center","__globals__":{"typography_typography":"globals\/typography?id=42dac7a"},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]}},"elements":[],"widgetType":"heading"},{"id":"44e5fd59","elType":"container","settings":{"content_width":"full","margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"40","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"7aa4d553","elType":"widget","widgetType":"nested-accordion","settings":{"items":[{"item_title":"Was ist ein \u201eGxP\u2011Friendly Audit\u201c f\u00fcr SaaS\u2011Plattformen \u2013 und wie unterscheidet es sich von einem klassischen Supplier-\/IT\u2011Audit?","_id":"a8c5d3b"},{"item_title":"Welche Regularien und Leitlinien adressiert ein GxP\u2011Friendly SaaS\u2011Audit typischerweise?","_id":"4af6865"},{"item_title":"Welche Pr\u00fcfschwerpunkte sind bei einem GxP\u2011Friendly Audit f\u00fcr SaaS am wichtigsten?","_id":"c5d09d8"},{"item_title":"Welche Evidenzen\/Nachweise werden in einem GxP\u2011Friendly Audit f\u00fcr SaaS akzeptiert?","_id":"94b6375"},{"item_title":"Kann ein GxP\u2011Friendly Audit die Validierung (CSV\/CSA) ersetzen?","_id":"970963c"}],"accordion_item_title_position_horizontal":"stretch","accordion_item_title_icon_position":"end","accordion_item_title_icon":{"value":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/12\/plus_icon.svg","id":1859},"library":"svg"},"accordion_item_title_icon_active":{"value":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/12\/minus_icon.svg","id":1858},"library":"svg"},"accordion_item_title_space_between":{"unit":"px","size":20,"sizes":[]},"accordion_background_normal_background":"classic","accordion_border_normal_border":"none","accordion_border_radius":{"unit":"px","top":"30","right":"30","bottom":"30","left":"30","isLinked":false},"accordion_padding":{"unit":"px","top":"20","right":"30","bottom":"20","left":"30","isLinked":false},"icon_size":{"unit":"px","size":32,"sizes":[]},"normal_icon_color":"#80636300","hover_icon_color":"#02010100","active_icon_color":"#02010100","content_border_border":"none","content_border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"content_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_element_width":"initial","_element_custom_width":{"unit":"%","size":80,"sizes":[]},"_flex_align_self":"center","__globals__":{"accordion_background_normal_color":"globals\/colors?id=aaddc3b","title_typography_typography":"globals\/typography?id=538daf9","normal_title_color":"globals\/colors?id=secondary","hover_title_color":"globals\/colors?id=secondary","active_title_color":"globals\/colors?id=secondary"},"_element_custom_width_tablet":{"unit":"%","size":100,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":"","sizes":[]},"title_typography_typography":"custom","title_typography_font_family":"Poppins","title_typography_font_size":{"unit":"custom","size":"clamp(0.875rem, 0.8056rem + 0.2222vw, 1rem)","sizes":[]},"title_typography_font_weight":"400","title_typography_line_height":{"unit":"custom","size":"160%","sizes":[]},"hover_title_color":"#0C693F","active_title_color":"#0C693F","default_state":"all_collapsed"},"elements":[{"id":"36557191","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"463d48e","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"46a5d711","elType":"widget","settings":{"editor":"<p>Ein GxP\u2011Friendly Audit ist ein risikobasiertes, SaaS\u2011taugliches Lieferanten-\/Plattform\u2011Audit, das gezielt die Controls pr\u00fcft, die f\u00fcr GxP\u2011Compliance und Auditierbarkeit entscheidend sind (z. B. Datenintegrit\u00e4t, Zugriffskontrollen, Change\/Release, Incident\/DR). Es ber\u00fccksichtigt dabei die Cloud-Realit\u00e4t (Multi\u2011Tenant, Standardprodukt, h\u00e4ufige Releases, begrenzte individuelle Audit\u2011Zug\u00e4nge).<\/p><p><strong>Unterschiede zum klassischen Audit:<\/strong><\/p><ul><li><strong>Shared Responsibility<\/strong> im Fokus: Klarer Zuschnitt, was der SaaS\u2011Provider verantwortet und was der Kunde organisatorisch\/prozessual sicherstellen muss.<\/li><li><strong>Evidenz pragmatisch<\/strong>: Nutzt realistische SaaS\u2011Nachweise (z. B. SOC\/ISO, Trust\u2011Center\u2011Artefakte) statt \u201eOn\u2011Prem\u201c-Artefakte zu erwarten, die SaaS oft nicht liefern kann.<\/li><li><strong>GxP\u2011Impact<\/strong> statt Vollabdeckung: Pr\u00fcft bevorzugt GxP\u2011kritische Bereiche statt \u201ealles, was theoretisch m\u00f6glich ist\u201c.<\/li><li><strong>Entscheidungsorientiert:<\/strong> Liefert eine Go\/No\u2011Go\u2011f\u00e4hige Bewertung inkl. Auflagen und Massnahmenplan.<\/li><\/ul>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"30dabbe8","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"419e22f6","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"5568af38","elType":"widget","settings":{"editor":"<p>Ein GxP\u2011Friendly Audit \u201emapped\u201c die SaaS\u2011Controls typischerweise auf die regulatorischen Erwartungen rund um Computerized Systems und Datenintegrit\u00e4t. H\u00e4ufige Referenzen sind:<\/p><ul><li><strong>EU GMP inkl. Annex 11<\/strong>: Erwartungen an Betrieb, Sicherheit, Datenintegrit\u00e4t, Audit Trails, Lieferantensteuerung, Changes.<\/li><li><strong>GAMP 5<\/strong>: Leitlinie f\u00fcr risikobasiertes Vorgehen, Supplier Assessment, angemessene Verifikation\/Validierung.<\/li><li><strong>FDA 21 CFR Part 11<\/strong> (falls relevant): Anforderungen an elektronische Records und elektronische Signaturen.<\/li><li><strong>Data Integrity (ALCOA+)<\/strong> als Leitprinzip: Nachvollziehbarkeit, Vollst\u00e4ndigkeit, Unver\u00e4nderbarkeit, Verf\u00fcgbarkeit.<\/li><\/ul><p>Wichtig f\u00fcr Entscheider:<br \/>Nicht jede SaaS\u2011Nutzung ist automatisch \u201ePart\u201111\u2011kritisch\u201c. Relevanz h\u00e4ngt stark davon ab, ob die Plattform GxP\u2011Records erzeugt\/verwaltet und ob elektronische Signaturen eingesetzt werden.<\/p>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"2b933db4","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"77fefc68","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"8239be5","elType":"widget","settings":{"editor":"<p>Die wichtigsten Pr\u00fcfschwerpunkte sind die Controls, die direkt die Datenintegrit\u00e4t, Compliance\u2011Nachvollziehbarkeit und Betriebssicherheit beeinflussen:<\/p><p><strong>Audit Trail &amp; Datenintegrit\u00e4t<\/strong><\/p><ul><li>Ist der Audit Trail vollst\u00e4ndig (wer\/was\/wann\/warum), aktivierbar\/konfigurierbar, schutzf\u00e4hig und auswertbar?<\/li><li>K\u00f6nnen Records\/Audit Trails exportiert und f\u00fcr Audits langfristig genutzt werden<\/li><\/ul><p><strong>Identity &amp; Access Management (IAM)<\/strong><\/p><ul class=\"check-list\"><li>Rollen-\/Berechtigungskonzept (RBAC), Least Privilege, Admin\u2011Kontrollen<\/li><li>MFA\/SSO, User Lifecycle (Joiner\/Mover\/Leaver), Rezertifizierungen<\/li><\/ul><p><strong>Change- &amp; Release\u2011Management (SaaS\u2011Updatef\u00e4higkeit)<\/strong><\/p><ul><li>Wie werden Changes getestet, freigegeben und kommuniziert?<\/li><li>Gibt es Impact\u2011Bewertungen, Release Notes, ggf. Feature\u2011Toggles\/konfigurierbare Funktionen?<\/li><\/ul><p><strong>Backup\/Restore &amp; Business Continuity \/ Disaster Recovery<\/strong><\/p><ul><li>Definierte RPO\/RTO, Restore\u2011Tests, Nachweise \u00fcber DR\u2011\u00dcbungen<\/li><li>Verf\u00fcgbarkeit &amp; Wiederherstellbarkeit GxP\u2011kritischer Daten<\/li><\/ul><p><strong>Incident-, Problem- &amp; Vulnerability\u2011Management<\/strong><\/p><ul><li>Meldeprozesse, SLAs, RCA, CAPA\u2011Mechanismen<\/li><li>Patch\u2011\/Vulnerability\u2011Handling, Security Monitoring<\/li><\/ul><p>Erg\u00e4nzend oft entscheidend: Datenlokation\/Subprocessor\u2011Transparenz, Logging\/Monitoring, Schnittstellen &amp; Integrationen, Konfigurationskontrolle.<\/p>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"6047a741","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"5b87de1e","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"4f29af84","elType":"widget","settings":{"editor":"<p>Akzeptierte Evidenzen sind typischerweise standardisierte, auditierte Nachweise und prozessuale Artefakte, die die Wirksamkeit der Controls belegen, z. B.:<\/p><ul><li><strong>SOC 2 Type II<\/strong> (inkl. Scope\/Zeitraum und getestete Controls)<\/li><li><strong>ISO 27001 Zertifizierung<\/strong> (plus relevante Anh\u00e4nge\/Scope, ggf. Statement of Applicability)<\/li><li><strong>Trust Center \/ Compliance Portal<\/strong> (Policies, Prozessbeschreibungen, Kontroll\u00fcbersichten)<\/li><li><strong>SDLC-\/Change\u2011Prozessnachweise<\/strong> (Release Notes, Change\u2011Workflows, Testzusammenfassungen)<\/li><li><strong>BCP\/DR\u2011Nachweise<\/strong> (DR\u2011Testberichte, Ergebnisse, Verbesserungsmassnahmen)<\/li><li><strong>Incident-\/Security\u2011Nachweise<\/strong> (Prozess, Ticket-\/RCA\u2011Beispiele in anonymisierter Form)<\/li><li><strong>Subprocessor\u2011Listen &amp; Data Processing Agreements (DPA)<\/strong>, Datenfluss-\/Architektur\u00fcbersichten<\/li><\/ul>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true},{"id":"4c981568","elType":"container","settings":{"_title":"","content_width":"full","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"background_color":""}},"elements":[{"id":"1e630a21","elType":"container","settings":{"flex_direction":"column","background_background":"classic","border_border":"none","border_radius":{"unit":"px","top":"0","right":"0","bottom":"30","left":"30","isLinked":false},"margin":{"unit":"px","top":"-21","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"30","bottom":"20","left":"30","isLinked":false},"__globals__":{"background_color":"globals\/colors?id=aaddc3b"}},"elements":[{"id":"5153330f","elType":"widget","settings":{"editor":"<p>Ein GxP\u2011Friendly Audit ersetzt eine kundeninterne Validierung in der Regel nicht vollst\u00e4ndig, kann sie aber deutlich verschlanken und beschleunigen.<\/p><p>Was das Audit typischerweise leistet:<\/p><ul><li>Verifiziert die <strong>Provider\u2011Controls<\/strong> (z. B. Security, Ops, SDLC) als belastbare Basis f\u00fcr Supplier Qualification<\/li><li>Liefert Input f\u00fcr <strong>CSA\/CSV\u2011Scope<\/strong>: Was kann man als \u201eSupplier Evidence\u201c \u00fcbernehmen, was muss der Kunde selbst testen?<\/li><li>Erstellt eine <strong>Shared Responsibility Matrix<\/strong>, die klare Kundenmassnahmen ableitet (SOPs, Rollenmodell, Periodic Review, Konfigurationskontrolle)<\/li><\/ul>","_element_width":"inherit","_element_custom_width":{"unit":"%","size":100,"sizes":[]},"_background_background":"classic","__globals__":{"typography_typography":"globals\/typography?id=text","text_color":"","_background_color":"globals\/colors?id=58e2bdc"},"_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":true,"isLocked":true}]}],"isInner":true}],"isInner":false},{"id":"643854bd","elType":"container","settings":{"flex_direction":"column","flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"margin":{"unit":"px","top":"-50","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"0","right":"20","bottom":"80","left":"20","isLinked":false},"_title":"Weitere Artikel","margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"75","right":"20","bottom":"75","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"50","right":"20","bottom":"50","left":"20","isLinked":false},"flex_justify_content":"center"},"elements":[{"id":"4fd289b3","elType":"widget","settings":{"title":"Magazin","_margin":{"unit":"px","top":"0","right":"0","bottom":"20","left":"0","isLinked":false},"_padding":{"unit":"px","top":"8","right":"13","bottom":"8","left":"13","isLinked":false},"_flex_align_self":"center","_background_background":"gradient","_background_color_b":"","_border_radius":{"unit":"px","top":"100","right":"100","bottom":"100","left":"100","isLinked":true},"__globals__":{"title_color":"globals\/colors?id=9b310c9","_background_color":"globals\/colors?id=accent","typography_typography":"globals\/typography?id=secondary"},"header_size":"div"},"elements":[],"widgetType":"heading"},{"id":"52106f4c","elType":"widget","settings":{"title":"Weitere Artikel aus dem Blog","align":"center","_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a"},"_element_custom_width_tablet":{"unit":"%","size":80,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"_padding_mobile":{"unit":"px","top":"10","right":"0","bottom":"20","left":"0","isLinked":false},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"25940306","elType":"widget","settings":{"template_id":2842,"alternate_templates":[{"template_id":null,"_id":"de51286"}],"pagination_page_limit":"5","pagination_prev_label":"Voriger","pagination_next_label":"N\u00e4chster","text":"Load More","load_more_no_posts_custom_message":"No more posts to show","nothing_found_message_text":"It seems we can\u2019t find what you\u2019re looking for.","columns_tablet":1,"posts_per_page":3,"equal_height":"yes","_padding":{"unit":"px","top":"60","right":"0","bottom":"60","left":"0","isLinked":false}},"elements":[],"widgetType":"loop-grid"}],"isInner":false}],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)<\/title>\n<meta name=\"description\" content=\"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)\" \/>\n<meta property=\"og:description\" content=\"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat\" \/>\n<meta property=\"og:url\" content=\"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/\" \/>\n<meta property=\"og:site_name\" content=\"DHC Consulting\" \/>\n<meta property=\"article:published_time\" content=\"2026-03-23T11:39:57+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-09T18:18:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"350\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"kdemmer\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Geschrieben von\" \/>\n\t<meta name=\"twitter:data1\" content=\"kdemmer\" \/>\n\t<meta name=\"twitter:label2\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data2\" content=\"10\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/\"},\"author\":{\"name\":\"kdemmer\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#\\\/schema\\\/person\\\/baadfb23f56889296f29ae6c48ec5b83\"},\"headline\":\"GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien\",\"datePublished\":\"2026-03-23T11:39:57+00:00\",\"dateModified\":\"2026-05-09T18:18:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/\"},\"wordCount\":1928,\"publisher\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"articleSection\":[\"GxP Compliance \\\/ CSV\"],\"inLanguage\":\"de-CH\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/\",\"name\":\"GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"datePublished\":\"2026-03-23T11:39:57+00:00\",\"dateModified\":\"2026-05-09T18:18:18+00:00\",\"description\":\"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#breadcrumb\"},\"inLanguage\":\"de-CH\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"de-CH\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#primaryimage\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"contentUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/friendly-audit.webp\",\"width\":1200,\"height\":350,\"caption\":\"Zwei Personen in Laborkleidung betrachten ein Tablet \u2013 symbolisch f\u00fcr die Bewertung einer GxP-konformen SaaS-Plattform f\u00fcr klinische Studien.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/gxp-friendly-audit-fuer-saas-plattform\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/beispiel-seite\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#website\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/\",\"name\":\"DHC Consulting\",\"description\":\"Beratungshaus f\u00fcr SAP Life Sciences, Qualit\u00e4tsmanagement und GxP Compliance\",\"publisher\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"de-CH\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#organization\",\"name\":\"DHC Consulting\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"de-CH\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/Logo.svg\",\"contentUrl\":\"https:\\\/\\\/dhc.ima.vc\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/Logo.svg\",\"width\":125,\"height\":31,\"caption\":\"DHC Consulting\"},\"image\":{\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/dhc.ima.vc\\\/ch\\\/#\\\/schema\\\/person\\\/baadfb23f56889296f29ae6c48ec5b83\",\"name\":\"kdemmer\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)","description":"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"de_DE","og_type":"article","og_title":"GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)","og_description":"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat","og_url":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/","og_site_name":"DHC Consulting","article_published_time":"2026-03-23T11:39:57+00:00","article_modified_time":"2026-05-09T18:18:18+00:00","og_image":[{"width":1200,"height":350,"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","type":"image\/webp"}],"author":"kdemmer","twitter_card":"summary_large_image","twitter_misc":{"Geschrieben von":"kdemmer","Gesch\u00e4tzte Lesezeit":"10\u00a0Minuten"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#article","isPartOf":{"@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/"},"author":{"name":"kdemmer","@id":"https:\/\/dhc.ima.vc\/ch\/#\/schema\/person\/baadfb23f56889296f29ae6c48ec5b83"},"headline":"GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien","datePublished":"2026-03-23T11:39:57+00:00","dateModified":"2026-05-09T18:18:18+00:00","mainEntityOfPage":{"@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/"},"wordCount":1928,"publisher":{"@id":"https:\/\/dhc.ima.vc\/ch\/#organization"},"image":{"@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#primaryimage"},"thumbnailUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","articleSection":["GxP Compliance \/ CSV"],"inLanguage":"de-CH"},{"@type":"WebPage","@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/","url":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/","name":"GxP-Friendly Audit f\u00fcr Ledidi Trials (SaaS-Plattform)","isPartOf":{"@id":"https:\/\/dhc.ima.vc\/ch\/#website"},"primaryImageOfPage":{"@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#primaryimage"},"image":{"@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#primaryimage"},"thumbnailUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","datePublished":"2026-03-23T11:39:57+00:00","dateModified":"2026-05-09T18:18:18+00:00","description":"Lesen Sie im Blogbeitrag, wie DHC im Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits die SaaS-Plattform\u00a0Ledidi\u00a0Trials umfassend bewertet hat","breadcrumb":{"@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#breadcrumb"},"inLanguage":"de-CH","potentialAction":[{"@type":"ReadAction","target":["https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/"]}]},{"@type":"ImageObject","inLanguage":"de-CH","@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#primaryimage","url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","contentUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/friendly-audit.webp","width":1200,"height":350,"caption":"Zwei Personen in Laborkleidung betrachten ein Tablet \u2013 symbolisch f\u00fcr die Bewertung einer GxP-konformen SaaS-Plattform f\u00fcr klinische Studien."},{"@type":"BreadcrumbList","@id":"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Start","item":"https:\/\/dhc.ima.vc\/ch\/beispiel-seite\/"},{"@type":"ListItem","position":2,"name":"GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien"}]},{"@type":"WebSite","@id":"https:\/\/dhc.ima.vc\/ch\/#website","url":"https:\/\/dhc.ima.vc\/ch\/","name":"DHC Consulting","description":"Beratungshaus f\u00fcr SAP Life Sciences, Qualit\u00e4tsmanagement und GxP Compliance","publisher":{"@id":"https:\/\/dhc.ima.vc\/ch\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/dhc.ima.vc\/ch\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"de-CH"},{"@type":"Organization","@id":"https:\/\/dhc.ima.vc\/ch\/#organization","name":"DHC Consulting","url":"https:\/\/dhc.ima.vc\/ch\/","logo":{"@type":"ImageObject","inLanguage":"de-CH","@id":"https:\/\/dhc.ima.vc\/ch\/#\/schema\/logo\/image\/","url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/Logo.svg","contentUrl":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/Logo.svg","width":125,"height":31,"caption":"DHC Consulting"},"image":{"@id":"https:\/\/dhc.ima.vc\/ch\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/dhc.ima.vc\/ch\/#\/schema\/person\/baadfb23f56889296f29ae6c48ec5b83","name":"kdemmer"}]}},"_links":{"self":[{"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/posts\/12545","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/comments?post=12545"}],"version-history":[{"count":0,"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/posts\/12545\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/media\/15564"}],"wp:attachment":[{"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/media?parent=12545"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/categories?post=12545"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dhc.ima.vc\/ch\/wp-json\/wp\/v2\/tags?post=12545"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}