{"id":12583,"date":"2025-07-22T16:13:01","date_gmt":"2025-07-22T14:13:01","guid":{"rendered":"https:\/\/dhc.ima.vc\/drafts-veroeffentlicht-annex-11-annex-22\/"},"modified":"2026-05-09T19:22:11","modified_gmt":"2026-05-09T17:22:11","slug":"drafts-veroeffentlicht-annex-11-annex-22","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/ch\/drafts-veroeffentlicht-annex-11-annex-22\/","title":{"rendered":"Drafts ver\u00f6ffentlicht: Annex 11 &#038; neuer Annex 22"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12583\" class=\"elementor elementor-12583 elementor-8744\" 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-11a4c88 e-flex e-con-boxed e-con e-parent\" data-id=\"11a4c88\" 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-768d3d0f e-con-full e-flex e-con e-child\" data-id=\"768d3d0f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-4e87f91d e-con-full e-flex e-con e-child\" data-id=\"4e87f91d\" 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-4fe2c71f elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"4fe2c71f\" 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\">Drafts ver\u00f6ffentlicht: Annex 11 &#038; neuer Annex 22<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-617c4168 elementor-widget elementor-widget-text-editor\" data-id=\"617c4168\" 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\">Am 7. Juli 2025 hat die Europ\u00e4ische Kommission gemeinsam mit der PIC\/S die lange erwarteten Entw\u00fcrfe zur \u00dcberarbeitung des Annex 11 \u201eComputerised Systems\u201c sowie den vollst\u00e4ndig neuen Annex 22 \u201eArtificial Intelligence\u201c ver\u00f6ffentlicht. Parallel wurde auch Kapitel 4 \u201eDokumentation\u201c des EU-GMP-Leitfadens \u00fcberarbeitet.\u00a0<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39f1ce66 elementor-author-box--align-left elementor-author-box--layout-image-left elementor-widget elementor-widget-author-box\" data-id=\"39f1ce66\" 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\/karsten-schulz-dhc-experte-300x300.webp\" alt=\"Picture of  Karsten Schulz, Director Sales, Marketing &amp; Business Development, 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\t Karsten Schulz, Director Sales, Marketing & Business Development, 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-3a5a2caa e-con-full e-flex e-con e-child\" data-id=\"3a5a2caa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b9d90af elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"5b9d90af\" 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\/annex11.webp\" class=\"attachment-full size-full wp-image-15561\" alt=\"\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11.webp 1200w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11-300x88.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11-1024x299.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11-768x224.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-52e93d4 e-flex e-con-boxed e-con e-parent\" data-id=\"52e93d4\" 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-2f87555 e-con-full e-flex e-con e-child\" data-id=\"2f87555\" 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-7d5a3e65 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7d5a3e65\" 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>Diese Richtlinien sind zentrale Bestandteile des GMP-Regelwerks f\u00fcr computergest\u00fctzte Systeme und KI-Anwendungen in der regulierten Industrie wie Pharma, Biotechnologie und Medizintechnik. Sie legen Anforderungen an die Integrit\u00e4t, Validierung und Kontrolle von IT-Systemen fest, die GMP-relevante Prozesse unterst\u00fctzen.\u00a0<\/p><p>Entsprechende Dokumente auf dem GLP und GCP Sektor wurden schon in den vergangenen Jahren publiziert. Die Drafts markieren einen entscheidenden Schritt hin zu einem modernen, risikobasierten Umgang mit digitalen Technologien in der GMP-Umgebung, stellen aber auch hohe Anforderungen an den Betreiber (regulated User).<\/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-bae2567 e-flex e-con-boxed e-con e-parent\" data-id=\"bae2567\" 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-cf45cfc e-con-full e-flex e-con e-child\" data-id=\"cf45cfc\" 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-3856547 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3856547\" 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 neu in Annex 11 und Annex 22?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb14fa7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"bb14fa7\" 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><strong>Die \u00fcberarbeiteten Inhalte des Annex 11 bringen Klarheit, Pr\u00e4zisierung und Aktualisierung in vielen Bereichen, insbesondere im Hinblick auf:<\/strong><\/p><ul class=\"check-list\"><li>Lifecycle-Management computergest\u00fctzter Systeme<img decoding=\"async\" class=\"alignright wp-image-11900\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik.jpg\" alt=\"\" width=\"400\" height=\"400\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik.jpg 1254w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-300x300.jpg 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-1024x1024.jpg 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-150x150.jpg 150w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-768x768.jpg 768w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/><\/li><li>Data Integrity und Audit Trails<\/li><li>Cloud- und SaaS-Nutzung<\/li><li>Lieferantenmanagement und Rollenverteilung<\/li><li>IT Sicherheit<\/li><\/ul><p>Gleichzeitig vermisst man allerdings auch einige Festlegungen, die in der fr\u00fcheren Version (von 2011) enthalten waren.<\/p><p><strong>Der neue Annex 22 nimmt erstmals K\u00fcnstliche Intelligenz (KI) und maschinelles Lernen (ML) explizit in den regulatorischen Fokus. Er adressiert u.a.:<\/strong><\/p><ul class=\"check-list\"><li>Validierungsanforderungen f\u00fcr KI\/ML-Modelle<\/li><li>Transparenz, Erkl\u00e4rbarkeit und Bias-Kontrolle<\/li><li>Verantwortlichkeiten bei Training, Einsatz und Monitoring<\/li><li>Risikobasierte Bewertung algorithmischer Entscheidungen<\/li><\/ul><p>Das Dokument ist ein guter erster Ansatz einer Regelung, die sicher noch des \u00f6fteren angepasst werden muss, um mit den schnellen \u00c4nderungen der Technologie Schritt halten zu k\u00f6nnen. Damit wird deutlich: Die Beh\u00f6rden schaffen einen klaren Rahmen, um Innovation und Regulierung in Einklang zu bringen \u2013 bei gleichzeitig wachsender Komplexit\u00e4t und Verantwortung f\u00fcr GxP-Verantwortliche.<\/p><p>Im \u00fcberarbeiteten Kapitel 4 (Documentation) des EU GMP Leitfadens werden einige f\u00fcr IT Systeme in Herstellung und Kontrolle wichtige Elemente neu betrachtet (z.B. Hybrid-gef\u00fchrte Dokumentation, Rohdaten, elektronische Signaturen). Damit m\u00fcssen auch einige Regelungen im Unternehmen angepasst 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-df2e4a2 e-flex e-con-boxed e-con e-parent\" data-id=\"df2e4a2\" 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-da8fa93 e-con-full e-flex e-con e-child\" data-id=\"da8fa93\" 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-9a4e66b elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"9a4e66b\" 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 bedeutet das f\u00fcr Compliance-Verantwortliche?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0358518 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"0358518\" 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 Entw\u00fcrfe erfordern konkrete Massnahmen in Unternehmen, die GxP-relevante IT-Systeme oder KI-basierte Funktionen einsetzen \u2013 sei es in der Qualit\u00e4tssicherung, Herstellung oder Logistik. Verantwortliche f\u00fcr Compliance, IT, Qualit\u00e4t und Validierung sollten jetzt:<\/p><ul class=\"check-list\"><li>Die Drafts analysieren und bewerten, welche Systeme, Technologien und Prozesse betroffen sind<\/li><li>Risikobasierte GAP-Analysen gegen\u00fcber den neuen Anforderungen durchf\u00fchren<\/li><li>Validierungs- und QM-Dokumentationen \u00fcberarbeiten, z.\u202fB. im Hinblick auf Rollen, Systemverantwortung, Cloud-Nutzung oder Sicherheit im IT Bereich.<\/li><li>KI-Projekte mit GxP-Relevanz neu bewerten: Wurde das verwendete Modell entsprechend den Anforderungen gepr\u00fcft? Ist das Modell erkl\u00e4rbar? Ist ein \u201eAI Lifecycle Management\u201c vorhanden?<\/li><\/ul><p style=\"text-align: left;\"><strong>Wichtig: Auch bestehende Systeme, die bereits validiert sind, m\u00fcssen im Kontext der neuen Anforderungen \u00fcberpr\u00fcft werden \u2013 insbesondere, wenn neue Technologien, Automatisierung oder externe Dienste (Service Provider) involviert sind.<\/strong><\/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-2f8c86d e-flex e-con-boxed e-con e-parent\" data-id=\"2f8c86d\" 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-bca14a4 e-con-full e-flex e-con e-child\" data-id=\"bca14a4\" 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-f4bd872 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f4bd872\" 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\">Wie kann Sie die DHC bei der Einhaltung der regulatorischen Anforderungen aus Annex 11 und 22 unterst\u00fctzen?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a5ff9e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4a5ff9e\" 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>Als Spezialist f\u00fcr SAP-L\u00f6sungen im Life-Sciences-Umfeld und mit fast 30 Jahren Erfahrung in der GxP-Compliance und Validierung unterst\u00fctzen wir Unternehmen gezielt in folgenden Bereichen:<\/p><ul class=\"check-list\"><li>GAP-Analyse &amp; Impact Assessment<\/li><li>Strukturierte Bewertung der neuen Annex-11- und Annex-22 und Kapitel 4-Anforderungen auf Ihre IT- und QM-Landschaft<\/li><li>Priorisierung der Handlungsfelder basierend auf Risiko und Relevanz<\/li><li>Validierungsstrategie &amp; Dokumentation<\/li><li>\u00dcberarbeitung von Validierungskonzepten, SOPs, RACI-Matrizen und Teststrategien<\/li><li>Etablierung eines nachvollziehbaren Life Cycle Managements f\u00fcr KI-gest\u00fctzte Systeme<\/li><li>KI-Compliance &amp; AI Readiness<\/li><li>Unterst\u00fctzung bei der regulatorischen Bewertung von KI\/ML-Systemen<\/li><li>Definition und Umsetzung von Kontrollmechanismen (z.\u202fB. Model Monitoring, Bias Detection, Explainability)<\/li><li>Tool-gest\u00fctzte Umsetzung mit SAP<\/li><li>Beratung zur Integration von Validierung in SAP-Prozesse (z.\u202fB. \u00fcber SAP Cloud ALM)<\/li><li>Einsatz des DHC Smart Validation Accelerator zur kosteng\u00fcnstigen Automatisierung und Dokumentation von Validierungsprozessen im SAP-Umfeld<\/li><li>Begleitung im Rahmen der SAP End-to-End Digital Validation Platform (E2E DVP)<\/li><\/ul><p style=\"text-align: left;\">\u00a0<\/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-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\">Drafts f\u00fcr KI &amp; ML ver\u00f6ffentlicht: Annex 11 &amp; neuer Annex 22 <\/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<div data-testid=\"markdown-response\"><p id=\"message\">Erhalten Sie eine erste Einsch\u00e4tzung der Auswirkungen und konkrete Ansatzpunkte f\u00fcr GAP-Analyse, Validierungsstrategie und KI-Compliance.<\/p><\/div>\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-1fad4f e-flex e-con-boxed e-con e-parent\" data-id=\"1fad4f\" 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-167b141b elementor-widget elementor-widget-heading\" data-id=\"167b141b\" 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-54620b9a elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"54620b9a\" 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 Annex 11, Annex 22 und Kapitel 4<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-64c6b135 e-con-full e-flex e-con e-child\" data-id=\"64c6b135\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-41b8f707 elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"41b8f707\" 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-1100\" 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-1100\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Was sind die wichtigsten Neuerungen in Annex 11? <\/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-1100\" class=\"elementor-element elementor-element-4efe986f e-con-full e-flex e-con e-child\" data-id=\"4efe986f\" 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-1100\" class=\"elementor-element elementor-element-761b047 e-flex e-con-boxed e-con e-child\" data-id=\"761b047\" 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-30470e26 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"30470e26\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tDer \u00fcberarbeitete Annex 11 sch\u00e4rft Anforderungen u. a. zu Lifecycle-Management computergest\u00fctzter Systeme, Data Integrity und Audit Trails, Cloud-\/SaaS-Nutzung, Lieferantenmanagement (Rollen, Vertr\u00e4ge, Verantwortung) sowie IT-Sicherheit. Dadurch steigen Transparenz, Nachvollziehbarkeit und Governance-Anforderungen f\u00fcr GxP-relevante IT-Landschaften.\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-1101\" 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-1101\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Was regelt der neue Annex 22 zur K\u00fcnstlichen Intelligenz? <\/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-1101\" class=\"elementor-element elementor-element-34b4a30c e-con-full e-flex e-con e-child\" data-id=\"34b4a30c\" 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-1101\" class=\"elementor-element elementor-element-35a216b1 e-flex e-con-boxed e-con e-child\" data-id=\"35a216b1\" 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-24e5a157 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"24e5a157\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\nAnnex 22 adressiert erstmals KI- und ML-Modelle im GMP-Umfeld. Im Fokus stehen Validierungsanforderungen, Transparenz und Erkl\u00e4rbarkeit, Bias-Kontrolle, Rollen und Verantwortlichkeiten im gesamten AI-Lifecycle sowie eine risikobasierte Bewertung algorithmischer Entscheidungen. Ziel ist ein Rahmen, der Innovation erm\u00f6glicht, ohne Patientensicherheit, Produktqualit\u00e4t und Datenintegrit\u00e4t zu gef\u00e4hrden.\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-1102\" 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-1102\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche Bedeutung hat das \u00fcberarbeitete Kapitel 4 \u201eDocumentation\u201c? <\/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-1102\" class=\"elementor-element elementor-element-18c17338 e-con-full e-flex e-con e-child\" data-id=\"18c17338\" 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-1102\" class=\"elementor-element elementor-element-14930ba5 e-flex e-con-boxed e-con e-child\" data-id=\"14930ba5\" 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-1026dfd6 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1026dfd6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\nKapitel 4 konkretisiert u. a. hybride Dokumentationsformen, Umgang mit Rohdaten und elektronische Signaturen. Damit m\u00fcssen Unternehmen ihre Dokumentations- und Freigabekonzepte, Rollenmodelle und IT-bezogenen QM-Regelungen anpassen \u2013 insbesondere dort, wo papierbasierte und elektronische Nachweise kombiniert werden.\n\n\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-1103\" 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-1103\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Was bedeutet das konkret f\u00fcr Compliance- und IT-Verantwortliche? <\/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-1103\" class=\"elementor-element elementor-element-4dfb8769 e-con-full e-flex e-con e-child\" data-id=\"4dfb8769\" 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-1103\" class=\"elementor-element elementor-element-57083963 e-flex e-con-boxed e-con e-child\" data-id=\"57083963\" 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-4346cb57 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4346cb57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tUnternehmen sollten die Drafts systematisch analysieren, risikobasierte GAP-Analysen durchf\u00fchren, Validierungs- und QM-Dokumentation (SOPs, Rollen, RACI, Sicherheitskonzepte) \u00fcberarbeiten und KI-Projekte mit GxP-Relevanz neu bewerten. Auch bereits validierte Systeme m\u00fcssen im Lichte der neuen Anforderungen \u00fcberpr\u00fcft werden, vor allem bei Cloud-\/SaaS-Nutzung, Automatisierung und ausgelagerten Services.\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-1104\" 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-1104\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Wie unterst\u00fctzt DHC bei der Umsetzung von Annex 11 und 22? <\/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-1104\" class=\"elementor-element elementor-element-60d9dece e-con-full e-flex e-con e-child\" data-id=\"60d9dece\" 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-1104\" class=\"elementor-element elementor-element-1f7c6420 e-flex e-con-boxed e-con e-child\" data-id=\"1f7c6420\" 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-42b6f095 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"42b6f095\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tDHC begleitet mit GAP-Analysen und Impact Assessments, der Weiterentwicklung von Validierungsstrategien, SOPs und Lifecycle-Konzepten \u2013 einschliesslich KI-Lifecycle-Management und AI-Compliance. Zus\u00e4tzlich werden toolgest\u00fctzte Ans\u00e4tze mit SAP (z. B. SAP Cloud ALM, DHC Smart Validation Accelerator, SAP End-to-End DVP) genutzt, um Validierungs- und Compliance-Anforderungen effizient und auditfest umzusetzen.\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\" 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.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: 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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\" 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