{"id":16122,"date":"2026-05-05T10:27:49","date_gmt":"2026-05-05T08:27:49","guid":{"rendered":"https:\/\/dhc.ima.vc\/?p=16122"},"modified":"2026-05-09T23:51:48","modified_gmt":"2026-05-09T21:51:48","slug":"sap-innovation-trifft-gxp-compliance","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/ch\/sap-innovation-trifft-gxp-compliance\/","title":{"rendered":"SAP-Innovation trifft auf GxP-Compliance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"16122\" class=\"elementor elementor-16122 elementor-14642\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-60056a86 e-con-full e-flex e-con e-parent\" data-id=\"60056a86\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-733bf54b e-flex e-con-boxed e-con e-child\" data-id=\"733bf54b\" 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-83bd165 e-con-full e-flex e-con e-child\" data-id=\"83bd165\" 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-25a86202 e-flex e-con-boxed e-con e-parent\" data-id=\"25a86202\" 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-73355a8a e-con-full e-flex e-con e-child\" data-id=\"73355a8a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-1cb9d5f1 e-con-full e-flex e-con e-child\" data-id=\"1cb9d5f1\" 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-639a9390 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"639a9390\" 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\">SAP-Innovation trifft auf GxP-Compliance<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-77ed5247 elementor-widget elementor-widget-text-editor\" data-id=\"77ed5247\" 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>Wie m\u00fcssen sich Validierungsans\u00e4tze vor dem Hintergrund aktueller SAP-Innovationen. ver\u00e4ndern? Diese Herausforderungen waren Thema des Vortrag von Stefan Staub beim SAP Executive Exchange Forum for Life Sciences 2026 in Z\u00fcrich.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33627b86 elementor-author-box--align-left elementor-widget elementor-widget-author-box\" data-id=\"33627b86\" 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\/stefan_staub.webp\" alt=\"Picture of Stefan Staub, Partner &amp; Principal Consultant, DHC AG (CH)\" 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\tStefan Staub, Partner & Principal Consultant, DHC AG (CH)\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-6c348001 e-con-full e-flex e-con e-child\" data-id=\"6c348001\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7f14f18 elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"7f14f18\" 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\/05\/sap-innivation-gxp-compliance.webp\" class=\"attachment-full size-full wp-image-16121\" alt=\"Erfahren Sie, wie SAP Innovation und GxP Compliance vereint: Digitale Validierung, Cloud-L\u00f6sungen und automatisierte Prozesse f\u00fcr die Life Sciences Branche.\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/sap-innivation-gxp-compliance.webp 1200w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/sap-innivation-gxp-compliance-300x88.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/sap-innivation-gxp-compliance-1024x299.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/sap-innivation-gxp-compliance-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-6bdd04a0 e-flex e-con-boxed e-con e-parent\" data-id=\"6bdd04a0\" 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-3b12fced e-con-full e-flex e-con e-child\" data-id=\"3b12fced\" 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-4a0bc1d elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4a0bc1d\" 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>Cloud Computing<\/strong>, vor allem der Trend hin zu Public Cloud \/ SaaS L\u00f6sungen, zwingt die regulierten Unternehmen sich mit k<strong>\u00fcrzeren Release-Zyklen<\/strong> auseinanderzusetzen. Trendthema Nummer 1, die <strong>K\u00fcnstliche Intelligenz (KI bzw. AI)<\/strong> wird mit innovativen Anwendungen die Prozesse in der Life Science Industrie in den kommenden Jahren stark ver\u00e4ndern. SAP spielt hier an vorderster Front und die neuen technologischen M\u00f6glichkeiten werden den Unternehmen laufend in den SAP-Produkten zur Verf\u00fcgung gestellt. <br \/>W\u00e4hrend die regulatorische Erwartung (Sicherstellung von Produktqualit\u00e4t, Patientensicherheit und Datenintegrit\u00e4t) gleichbleibt, ver\u00e4ndern sich die Anforderungen an die Validierungsans\u00e4tze rasch. Der Vortrag zeigte, wie Unternehmen diese neuen Herausforderungen erfolgreich meistern k\u00f6nnen: <strong>Risikobasierte Lieferantenbewertung und -auswahl mit Unterst\u00fctzung durch Audits und der GxP Cloud Control Matrix, kontinuierliche und automatisierte Validierung mit Hilfe einer End-to-End Digital Validation Platform.<\/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-36a8978a e-flex e-con-boxed e-con e-parent\" data-id=\"36a8978a\" 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-476ae73c e-con-full e-flex e-con e-child\" data-id=\"476ae73c\" 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-77c8b949 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"77c8b949\" 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\">\u201cExciting times\u201c \u2013 aber mit neuen Compliance-Herausforderungen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-19c47d6e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"19c47d6e\" 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>Beim SAP Executive Exchange Forum for Life Sciences 2026 in Z\u00fcrich hielt Stefan Staub, Partner &amp; Principal Consultant der DHC Schweiz, den Vortrag <strong>\u201eSAP Innovation meets GxP Compliance \u2013 An Overview\u201c<\/strong>. Im Mittelpunkt stand eine Frage, die aktuell viele QA-, CSV- und IT-Teams besch\u00e4ftigt:<br \/><strong>Wie k\u00f6nnen Life-Sciences-Unternehmen SAP-Innovation (Private und Public Cloud SaaS L\u00f6sungen, KI-Anwendungen, \u2026) nutzen \u2013 ohne GxP-Compliance zu riskieren?<\/strong><\/p><h3>Aktuell zeigt sich dabei folgendes Spannungsfeld:<\/h3><p>Technologieanbieter treiben Innovation kontinuierlich voran, Unternehmen wollen und werden sie zeitnah nutzen \u2013 aber Gesetzgeber, Regulatoren ben\u00f6tigen Zeit, um Wissen zu generieren, dazugeh\u00f6rende Risiken zu identifizieren und entsprechende Gesetze und Leitlinien zu definieren. <br \/><br \/>QA\/CSV-Teams stehen dadurch h\u00e4ufig zwischen \u201etechnologisch m\u00f6glich\u201c und \u201eregulatorisch eindeutig geregelt\u201c.<\/p><ul><li>Die gute Nachricht: Die Ziele der Regulierung bleiben stabil: Sicherstellung von Produktqualit\u00e4t, Patientensicherheit und Datenintegrit\u00e4t.<\/li><li>Die herausfordernde Nachricht: Die technologischen Rahmenbedingungen ver\u00e4ndern sich schneller als je zuvor \u2013 und zwingen Unternehmen dazu, die Validierungsans\u00e4tze der neuen Realit\u00e4t, trotz noch fehlender Gesetze und Leitlinien und der damit verbunden Unsicherheit, anzupassen.<\/li><\/ul><p>Klassische, stark dokumentenzentrierte Validierungsans\u00e4tze aus \u201eWaterfallmodell-Zeiten\u201c geraten zunehmend an Grenzen, wenn sich die neuen IT-Systeme wie ein \u201eOrganismus\u201c permanent ver\u00e4ndern. <\/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-2d114c7a e-flex e-con-boxed e-con e-parent\" data-id=\"2d114c7a\" 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-2d945539 e-con-full e-flex e-con e-child\" data-id=\"2d945539\" 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-7d3a6643 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"7d3a6643\" 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\">Von \u201elinear &amp; dokumentenzentriert\u201c zu \u201econtinuous &amp; risikozentriert &amp; automatisiert\"<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-443d6ec9 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"443d6ec9\" 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>Viele Validierungsans\u00e4tze stammen aus einer Zeit, in der Software vergleichsweise <strong>statisch<\/strong> war. Entsprechend waren Ans\u00e4tze zur Computersystemvalidierung (CSV) stark <strong>dokumentationsgetrieben<\/strong>, teils sogar papierbasiert, linear entlang eines klassischen Wasserfallmodells. Das gilt in Teilen bis heute \u2013 wird aber zunehmend als zu langsam, b\u00fcrokratisch und teuer erlebt.<\/p><p>Das zentrale Bild: IT-Systeme verhalten sich heute eher wie ein <strong>\u201eOrganismus\u201c<\/strong>, der sich kontinuierlich ver\u00e4ndert: Cloud-Services, vor allem SaaS-Anwendungen und die damit verbundenen schnellen Release-Zyklen beschleunigen die \u00c4nderungsdynamik. Mit den aufkommenden KI-Anwendungen werden sich die Anforderungen weiter erh\u00f6hen.<\/p><p>Folglich muss sich die Validierung in Richtung einer kontinuierlichen Validierung <strong>(Continuous Validation)<\/strong> entwickeln. Rein manuell l\u00e4sst sich das Tempo, vor allem beim Change Impact Assessment und dem notwendigen Testen, nicht halten; Testautomatisierung wird zur Notwendigkeit (und perspektivisch k\u00f6nnen auch KI-Ans\u00e4tze Validierungsaktivit\u00e4ten unterst\u00fctzen).<\/p><p>In einer SAP-Landschaft, die von Cloud-Services, h\u00e4ufigen Releases und neuen KI-Anwendungen gepr\u00e4gt ist, m\u00fcssen Validierungsans\u00e4tze und Validierungswerkzeuge k\u00fcnftig daher folgende Eigenschaften erf\u00fcllen:<\/p><ul><li><strong>Schnell &amp; agil<\/strong>: Validierung muss mit neuen und schnellen Software-Entwicklungsmethoden und den damit verbundenen Release-Zyklen \u201emitlaufen\u201c \u2013 nicht nachgelagert bremsend und Innovations- und Effizienzpotenziale verhindernd.<\/li><li><strong>Automatisiert<\/strong>: Wiederkehrende Pr\u00fcf- und Dokumentationsschritte<br \/>m\u00fcssen industrialisiert werden (z. B. Change-Impact-Assessment auf Basis Release Notes, Regressionstests, Traceability,).<\/li><li><strong>Supplier-supported<\/strong>: In Cloud Computing, z.B. SaaS sind die Lieferanten aufgrund ihrer Verantwortlichkeiten und Kontrolle der Infrastruktur-, Plattform- und Softwareebene aktiv in die Qualifizierungs- und Validierungsaktivit\u00e4ten einzubinden.<\/li><li><strong>Kontinuierlich validierend<\/strong>: \u201eStay validated\u201c wird zum Betriebsmodell \u2013<br \/>mit klarer Governance, Change Impact Analysis und laufender<br \/>\u00dcberwachung statt punktueller Validierung mit periodischer \u00dcberpr\u00fcfung.<\/li><li><strong>Vollst\u00e4ndig digitalisiert<\/strong>: CSV-Aktivit\u00e4ten werden k\u00fcnftig vollst\u00e4ndig elektronisch in integrierten, workflowgesteuerten CSV-Tools (Tool-Chain) als strukturierte Daten statt in isolierten Dokumenten gesteuert. Dadurch wird die audit-sichere Dokumentation automatisiert erzeugt, Compliance und Transparenz steigen, w\u00e4hrend Aufwand und Durchlaufzeiten f\u00fcr Validierung und Freigabe GxP-relevanter Systeme sinken.<\/li><li><b>KI-unterst\u00fctzt<\/b>: KI kann unterst\u00fctzen, Informationen zu strukturieren, \u00c4nderungen vorzubereiten oder Reviews zu beschleunigen \u2013 ohne die regulatorische Verantwortung zu \u201edelegieren\u201c.<\/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-4c1b62db e-flex e-con-boxed e-con e-parent\" data-id=\"4c1b62db\" 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-40807610 e-con-full e-flex e-con e-child\" data-id=\"40807610\" 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-1d803162 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"1d803162\" 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\">Cloud: \u201eShared responsibility\u201c \u2013  aber einseitige Accountability \/ Rechenschaftspflicht<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-213ab388 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"213ab388\" 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 Kernpunkt im Cloud-Kontext l\u00e4sst sich in einem Satz zusammenfassen:<\/p><p>Viele Aufgaben liegen nicht mehr unter direkter Kontrolle des regulierten Unternehmens \u2013 <strong>die Rechenschaftspflicht bleibt aber bei ihm<\/strong>.<\/p><p>Dieses Spannungsfeld von geteilter Verantwortung bei gleichzeitig einseitiger Rechenschaftspflicht (\u201eshared responsibility but one-sided accountability\u201c) erkl\u00e4rt, warum <strong>Lieferantenauswahl und Lieferantenqualifizierung <\/strong>im Cloud-Kontext nicht \u201eNice to have\u201c, sondern ein Muss sind: Niemand m\u00f6chte erst nach Vertragsabschluss feststellen, dass ein Anbieter GxP-F\u00e4higkeiten oder Qualifizierungsunterst\u00fctzung nicht liefern kann \u2013 und dann in Audits\/Inspektionen ohne Nachweise dastehen. Daher gibt es regulatorische Anforderungen, die verlangen, dass man diesen Auswahl- und Assessment-Prozess durchf\u00fchrt, bevor man die Zusammenarbeit startet.<\/p><p>Die folgende Abbildung konkretisiert das entlang der Cloud-Service-Modelle (IaaS\/PaaS\/SaaS): Provider verantworten u. a. sicheren Betrieb, Change Management und Datenintegrit\u00e4t die regulierte Organisation muss nachweisen, dass der Provider die Anforderungen erf\u00fcllt (Qualification) und muss Anwendungen \u201efit for intended use\u201c validieren.<\/p><p><img decoding=\"async\" class=\"aligncenter wp-image-15010 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions.webp\" alt=\"Vergleich der Verantwortlichkeiten in Cloud-Modellen (On-Premises, IaaS, PaaS, SaaS) mit Verschiebung zum Anbieter, w\u00e4hrend die Gesamtverantwortung beim Unternehmen bleibt.\" width=\"1734\" height=\"907\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions.webp 1734w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions-300x157.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions-1024x536.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions-768x402.webp 768w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions-1536x803.webp 1536w\" sizes=\"(max-width: 1734px) 100vw, 1734px\" \/><\/p><p>Zum Assessment eignen sich folgende zwei Methoden mit ihren<br \/>Varianten:<\/p><h3><strong>Risikobasierte Cloud Service Provider Bewertung<\/strong><\/h3><p>Es gibt verschiedene\u00a0Wege um Cloud Service Provider (CSP) zu bewerten. Je nach Kritikalit\u00e4t der Applikation\/des\u00a0Lieferanten, sind unterschiedliche durchzuf\u00fchren.<\/p><p><img decoding=\"async\" class=\"alignnone wp-image-15009 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/Risikobasierte-Cloud-Service-Provider-Bewertung.webp\" alt=\"\u00dcbersicht verschiedener Audit- und Bewertungsmethoden f\u00fcr Lieferanten (Assessment, Fragebogen, Audit) mit Vergleich von Aufwand, Einsatzbereich sowie Vor- und Nachteilen.\" width=\"1469\" height=\"851\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/Risikobasierte-Cloud-Service-Provider-Bewertung.webp 1469w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/Risikobasierte-Cloud-Service-Provider-Bewertung-300x174.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/Risikobasierte-Cloud-Service-Provider-Bewertung-1024x593.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/Risikobasierte-Cloud-Service-Provider-Bewertung-768x445.webp 768w\" sizes=\"(max-width: 1469px) 100vw, 1469px\" \/><\/p><h3><strong>GxP Cloud Control Matrix als strukturierter Nachweis<\/strong><\/h3><p>Basierend auf dem internationalen Standard der <strong>Cloud Controls Matrix<\/strong> der Cloud Security Alliance hat die DHC die GxP Cloud Control Matrix entwickelt, welche f\u00fcr Life Sciences Unternehmen um GxP-Anforderungen erweitert wurde (\u201eGxP-enhanced cloud control matrix\u201c). Die GxP CCM eignet sich ideal zur Bewertung von CSPs und als dokumentierter Nachweis, dass das geforderte Assessment durchgef\u00fchrt wurde.<\/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-4bfe8fc e-flex e-con-boxed e-con e-parent\" data-id=\"4bfe8fc\" 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-6b289de0 e-con-full e-flex e-con e-child\" data-id=\"6b289de0\" 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-3afa1fcd elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3afa1fcd\" 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\">Use Case:  Vertrauensaufbau zwischen  Cloud Service Provider (CSP) und reguliertem Unternehmen am Beispiel SAP Digital Manufacturing (SAP DM)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1653ea96 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"1653ea96\" 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 Voraussetzung f\u00fcr eine erfolgreiche langfristige Zusammenarbeit zwischen reguliertem Unternehmen und Cloud Service Provider (CSP) m\u00fcssen beide Seiten ihre Hausaufgaben erledigen:<\/p><p><span style=\"text-decoration: underline;\"><strong>Reguliertes Unternehmen:<\/strong><\/span><\/p><ul><li>CSP Auswahl und Bewertung (siehe vorg\u00e4ngiger Abschnitt)<\/li><li>Vertragliche Regelung der Zusammenarbeit, dazu geh\u00f6ren:<ul><li>Master Service Agreement (MSA) und Service Level Agreement (SLA)s<\/li><li>Quality Assurance Agreement (QAA)<\/li><li>Data Processing Agreement (DPA)<\/li><li>\u2026<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">Hierbei sollte das Unternehmen darauf achten, dass es die M\u00f6glichkeit hat, beim CSP Audits durchzuf\u00fchren.<\/p><ul><li>\u00dcberwachung der Compliance und der Service Qualit\u00e4t des CSP \u00fcber die Dauer der Zusammenarbeit.<\/li><\/ul><p><span style=\"text-decoration: underline;\"><strong>SAP als Cloud Service Provider (CSP) f\u00fcr die SAP DM<\/strong><\/span><\/p><p>SAP muss sicherstellen, dass regulatorische und funktionale Anforderungen in der Life Science Industry sichergestellt werden. Der Kunde, das regulierte Unternehmen, braucht die Unterst\u00fctzung bei der Qualifizierung und Validierung durch die SAP. \u00a0Folgendes bietet die SAP im Falle der DM mit dem Quality Requirement Schedule f\u00fcr ihre GxP relevanten Kunden:<\/p><ul><li>Qualit\u00e4tssicherungsmassnahmen im Bereich Softwareentwicklung und -operations inkl.<ul><li>Qualit\u00e4tsmanagementsystem (QMS)<\/li><li>SOP f\u00fcr den SDLC (Softwareentwicklungszyklus)<\/li><li>Zertifizierungen und Bescheinigungen<\/li><li>GxP-Whitepapers (SAP DM &amp; SAP BTP)<\/li><li>Rahmenwerk f\u00fcr interne Audits und Kontrollen<\/li><\/ul><\/li><li>Qualifizierte SaaS-L\u00f6sung inkl.<ul><li>SAP-DM-Produktzertifizierung<\/li><li>SAP-BTP-Plattformzertifizierung<\/li><li>Zertifizierung f\u00fcr Continuous Platform Services<\/li><li>Matrix zur R\u00fcckverfolgbarkeit regulatorischer Anforderungen<\/li><li>Audit vor Ort auf Anfrage<\/li><\/ul><\/li><li>Konzept f\u00fcr den Betrieb inkl.<ul><li>Standardarbeitsanweisungen (SOP) f\u00fcr IT-Betrieb und Servicemanagement<\/li><li>Service Level Agreements (SLAs)<\/li><li>Release-Management<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6074539 e-con-full e-flex e-con e-child\" data-id=\"6074539\" 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-03f27d5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"03f27d5\" 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\">Use Case: SaaS-Validierung am Beispiel SAP Digital Manufacturing (SAP DM)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2fbf431 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"2fbf431\" 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>Erkenntnisse und Lehren aus der SAP DM Validierung:<\/p><ol><li><strong> SAP DM Systemarchitektur, -grenze und -funktionalit\u00e4t<\/strong><\/li><\/ol><p>SAP DM ist eine SaaS-L\u00f6sung auf der SAP Business Technology Platform (BTP als PaaS), welche auf einer Hyperscaler IaaS l\u00e4uft. F\u00fcr regulierte Organisationen bedeutet das: keine direkte Kontrolle \u00fcber das System (Stichwort: geteilte Verantwortlichkeiten), aber vollumf\u00e4ngliche Rechenschaftspflicht (siehe hierzu die vorg\u00e4ngigen Kapitel).<\/p><ol start=\"2\"><li><strong> Ein (noch) konventioneller Ansatz kann funktionieren \u2013 aber\u2026<\/strong><\/li><\/ol><p>Eine klassische, sich am GAMP5 orientierende und Dokumenten-basierte Validierung auf einem DMS kann durchaus gut funktionieren. Der eigentliche Engpass bei einem solchen Vorgehen zeigt sich beim Change Management, insbesondere beim Change Impact Assessment sowie beim Regressionstesten und da konkret im Binden der Business-Ressourcen.<\/p><p>Quartalsweise werden von SAP neue Releases eingespielt, welche in einem 2-w\u00f6chigen Testfenster getestet werden m\u00fcssen. Eine Woche bevor das Testfenster ge\u00f6ffnet wird, werden die Release Notes\u00a0 (What\u2019s New) publiziert. Es ergeben sich zwei Herausforderungen:<\/p><ul><li>Change Impact Assessment<br \/>Eine der grossen Herausforderungen im SaaS Umfeld ist die Interpretation der Release Notes und damit auch das Change Impact Assessment. Typischerweise werden die SAP DM What\u2019s New eine Woche vor dem Testfenster publiziert. Den regulierten Unternehmen bleibt eine Woche die Release Notes auszuwerten und den Impact auf die genutzten Funktionalit\u00e4ten und Prozesse zu bewerten.<\/li><\/ul><ul><li>Testen<br \/>Test- bzw. Regressionstestplanung, Ressourcenbereitstellung und das Ausf\u00fchren der Tests, ist f\u00fcr viele Organisationen ein grosser Aufwand. Gr\u00f6ssere Organisationen k\u00f6nnen hier teilweise auf Test Factories ausweichen, welche das Testen f\u00fcrs Business \u00fcbernehmen. Kleinere Organisation haben diese M\u00f6glichkeiten nicht, und \u00fcberstrapazieren das Business mit den Testaktivit\u00e4ten. Auf Dauer ist hier das manuelle Testen keine L\u00f6sung.<\/li><\/ul><p>Das praktische Fazit: Mit einem konventionellen Ansatz kann man validiert bleiben \u2013 <strong>aber<\/strong> man kann nicht alle paar Wochen dauerhaft die Fachbereiche mit manuellen Tests blockieren. Langfristig f\u00fchrt kein Weg vorbei an einer <strong>Testautomatisierung<\/strong> sowie einer Digitalisierung\/Automatisierung von Change Impact Analyse, Dokumentationspflege und Testing.<\/p><p>Damit wird Tool-Unterst\u00fctzung in der Validierung vom \u201enice-to-have\u201c zum Muss. Wenn Release Notes in kurzen Abst\u00e4nden bewertet, Changes sauber zugeordnet, Dokumente gepflegt, Tests geplant\/ausgef\u00fchrt und Nachweise auditf\u00e4hig abgelegt werden m\u00fcssen, l\u00e4sst sich das weder dauerhaft manuell noch rein dokumentenzentriert skalieren.<br \/>Entscheidend ist eine durchg\u00e4ngige Kette aus Change-Impact-Bewertung, Dokumentenpflege, (automatisiertem) Testen und automatischer Traceability \u2013 sonst wird die Continuous Validation zur Dauerbelastung f\u00fcr IT, Fachbereich und QA\/CSV-Organisation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-10118c5 e-con-full e-flex e-con e-child\" data-id=\"10118c5\" 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-f27e77d elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f27e77d\" 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\">SAP\u2019s Initiative zur End-2-End Digital Validation Platform<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a75c708 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a75c708\" 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>Viele Organisationen haben in den letzten Jahren den <strong>SAP Solution Manager<\/strong> (SolDoc, ChaRM, ITSM, Testmanagement, ggf. Focused Build mit Test Step Designer usw.) oder auch andere Werkzeuge als zentrales\u00a0<strong>Valdierungswerkzeug<\/strong> genutzt. Aber: Der SAP Solution Manager l\u00e4uft Richtung Supportende, man muss sich mit \u201eWhat\u2019s next\u201c besch\u00e4ftigen.<\/p><p>SAP positioniert <strong>Cloud ALM<\/strong> als Solution Manager Nachfolger, aber es kann und will nicht die eierlegende Wollmilchsau der Validierungswerkzeuge werden.<\/p><p>Daher setzt SAP zusammen mit mehreren SAP-Partnern in einer aktuellen Initiative zur End-2-End Digital Validation Platform auf eine <strong>integrierte Toolchain <\/strong>bestehend aus:<\/p><ul><li><strong>SAP LeanIX: <\/strong>f\u00fcrs Enterprise Architecture Management (EAM)<\/li><li><strong>Signavio<\/strong>: f\u00fcrs Business Process Managmenet (BPM). Aus Validierungssicht ist Signavio ein guter Einstieg f\u00fcr die Prozessdefinition und -modellierung<\/li><li><strong>SAP Cloud ALM:<\/strong> als Zentrum f\u00fcr Application Lifecycle Management (ALM) inkl. Transport Management, Test Management, Requirements Management usw.<\/li><li><strong>Tricentis Tosca:<\/strong> f\u00fcr automatisiertes Testen<\/li><li><strong>p36<\/strong><strong>: <\/strong>f\u00fcr die Continuous Service Qualification, besonders f\u00fcr BTP Services<\/li><li><strong>DHC Smart Validation Accelerator<\/strong> (SVA): f\u00fcr das Management von Validierungsobjekten, Changes- und Dokumenten. Als wichtiger erg\u00e4nzender Baustein f\u00fcr die <b>Validierungsdokumentation, Versionierung, elektronische Workflows, Sign-offs und Traceability.<br \/><\/b>Der Smart Validation Accelerator erm\u00f6glicht elektronisch und integriert die Erstellung und Ablage von z.B.:<ul><li>Validierungspl\u00e4nen<\/li><li>Validierungsobjekten und URS, FS, Risikoanalysen usw.<\/li><li>technische Dokumentationen<\/li><li>Testreports, Sign-offs, Validierungsreports<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">und steuert die integrierte Zusammenarbeit innerhalb der Toolchain.<\/p><p>Aktuell arbeitet DHC an der Fertigstellung des Change Impact Analyzers, um \u201eWhat\u2019s New\u201c \/ Release Notes zu interpretieren und risikobasierte Change Impact Assessments zu unterst\u00fctzen, um zu entscheiden, welche Validierungsobjekte\/Dokumente betroffen sind und was zu regressionstesten ist. Damit m\u00f6chte man dem engen Zeitfenster im SaaS-Release-Management begegnen.<\/p><p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-15011 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva.webp\" alt=\"\" width=\"1672\" height=\"941\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva.webp 1672w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva-300x169.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva-1024x576.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva-768x432.webp 768w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva-1536x864.webp 1536w\" sizes=\"(max-width: 1672px) 100vw, 1672px\" \/><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c21caaa e-con-full e-flex e-con e-child\" data-id=\"c21caaa\" 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-f343b9b elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f343b9b\" 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\">Fazit<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9908613 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"9908613\" 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>Innovation ist m\u00f6glich <\/strong>und muss m\u00f6glich sein \u2013 Voraussetzung und auch Enabler dazu muss eine Validierungsvorgehensweise mit entsprechenden Tools bzw. einer Toolchain sein, die integriert, vollst\u00e4ndig <strong>digitalisiert<\/strong>, und <strong>automatisiert<\/strong> ist.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e784f20 e-con-full e-flex e-con e-child\" data-id=\"e784f20\" 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-882fb42 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"882fb42\" 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\">Sie m\u00f6chten mehr erfahren \u2013 jetzt unverbindliches 1:1-Expertengespr\u00e4ch vereinbaren<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f934576 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"f934576\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li>Planen Sie Cloud-\/SaaS-Einsatz in GxP-relevanten Prozessen oder stehen vor der Frage, wie Ihre Validierung mit Release-Zyklen Schritt h\u00e4lt?<br \/>Wir unterst\u00fctzen u. a. bei<\/li><li><strong>Supplier Qualification<\/strong> &amp; auditfester Nachweisf\u00fchrung<\/li><li><strong>Cloud\/SaaS GxP Assessments<\/strong><\/li><li><strong>Validierungsstrategie f\u00fcr IaaS, PaaS, SaaS<\/strong> \u00a0mit schnelleren Releasezyklen (inkl. Continuous Validation)<\/li><li><strong>Toolchain-Integration<\/strong> (SAP Cloud ALM \u00d7 Testautomation \u00d7 digitale Validierungsinhalte)<\/li><li><strong>Digital Validation Platform <\/strong>und <strong>DHC Smart Validation Accelerator<\/strong><strong><br \/><\/strong><\/li><\/ul><p>\u2192 Mehr zu unseren Beratungsleistungen zur <a href=\"https:\/\/dhc.ima.vc\/cloud-validierung\/\"><strong>Cloud- \/ SaaS-Validierung<\/strong>\u00a0<\/a><br \/>\u2192 Mehr zum <a href=\"https:\/\/dhc.ima.vc\/dhc-smart-validation-accelerator\/\"><strong>DHC Smart Validation Accelerator<\/strong><\/a><\/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-1dad2bbc e-flex e-con-boxed e-con e-child\" data-id=\"1dad2bbc\" 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-4afdf2a7 e-con-full e-flex e-con e-child\" data-id=\"4afdf2a7\" 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-6d85914f e-con-full e-flex e-con e-child\" data-id=\"6d85914f\" 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-489849a1 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"489849a1\" 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\">SAP Innovationen und GxP Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b2cfc0c elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"5b2cfc0c\" 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 m\u00f6chten mehr erfahren zu Validierungsans\u00e4tzen und -Tools f\u00fcr den Cloud-\/SaaS-Einsatz in GxP-relevanten Prozessen?\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53107c0b elementor-mobile-align-center custom-button elementor-widget elementor-widget-button\" data-id=\"53107c0b\" 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-435a7258 e-con-full e-flex e-con e-child\" data-id=\"435a7258\" 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-2fe18a1f elementor-author-box--image-valign-middle elementor-widget elementor-widget-author-box\" data-id=\"2fe18a1f\" 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.webp\" 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-574b70f7 e-flex e-con-boxed e-con e-parent\" data-id=\"574b70f7\" 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-24cde2ff elementor-widget elementor-widget-heading\" data-id=\"24cde2ff\" 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-5f618fec elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"5f618fec\" 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 Cloud- \/ SaaS<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-496e65e7 e-con-full e-flex e-con e-child\" data-id=\"496e65e7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-1abfffec elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"1abfffec\" 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-4480\" 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-4480\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Was bedeutet \u201eSAP Innovation meets GxP Compliance\u201c praktisch? <\/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-4480\" class=\"elementor-element elementor-element-49bb7811 e-con-full e-flex e-con e-child\" data-id=\"49bb7811\" 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-4480\" class=\"elementor-element elementor-element-4ddbeed9 e-flex e-con-boxed e-con e-child\" data-id=\"4ddbeed9\" 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-54e50e92 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"54e50e92\" 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>Dass Cloud- und SaaS-Innovation nur dann nachhaltig nutzbar ist, wenn Supplier Controls, Governance und Validierungsnachweise so aufgesetzt sind, dass sie h\u00e4ufige Changes auditf\u00e4hig abbilden.<\/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-4481\" 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-4481\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Warum reicht klassische, dokumentenzentrierte Validierung oft nicht mehr aus? <\/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-4481\" class=\"elementor-element elementor-element-771b90cd e-con-full e-flex e-con e-child\" data-id=\"771b90cd\" 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-4481\" class=\"elementor-element elementor-element-b8abe89 e-flex e-con-boxed e-con e-child\" data-id=\"b8abe89\" 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-4a82cc9d elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4a82cc9d\" 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>Weil Systeme sich kontinuierlich \u00e4ndern und die Ver\u00e4nderungsgeschwindigkeit manuell kaum wirtschaftlich abbildbar ist; es braucht industrialisierte, teilautomatisierte Ans\u00e4tze und eine kontinuierliche Validierungslogik.<\/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-4482\" 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-4482\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche Rolle spielt SAP Cloud ALM in der k\u00fcnftigen Toolchain? <\/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-4482\" class=\"elementor-element elementor-element-64cdeb7 e-con-full e-flex e-con e-child\" data-id=\"64cdeb7\" 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-4482\" class=\"elementor-element elementor-element-62bbc69d e-flex e-con-boxed e-con e-child\" data-id=\"62bbc69d\" 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-14450bec elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"14450bec\" 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>Cloud ALM wird als zentraler ALM-Baustein gesehen, der in einer Toolchain mit Prozess-\/Architektur-Tools und Testautomatisierung zusammenspielt; f\u00fcr GxP-relevante Validierungsobjekte braucht es h\u00e4ufig erg\u00e4nzende L\u00f6sungen f\u00fcr Dokumentation, Workflows und Traceability.<\/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<\/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-630dfb87 e-flex e-con-boxed e-con e-parent\" data-id=\"630dfb87\" 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-340b0593 elementor-widget elementor-widget-heading\" data-id=\"340b0593\" 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-592994c9 elementor-widget elementor-widget-heading\" data-id=\"592994c9\" 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-5d438874 elementor-grid-tablet-1 elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"5d438874\" 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;:[]}}\" 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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\" 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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 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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 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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 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Computing<\/strong>, vor allem der Trend hin zu Public Cloud \/ SaaS L\u00f6sungen, zwingt die regulierten Unternehmen sich mit k<strong>\u00fcrzeren Release-Zyklen<\/strong> auseinanderzusetzen. Trendthema Nummer 1, die <strong>K\u00fcnstliche Intelligenz (KI bzw. AI)<\/strong> wird mit innovativen Anwendungen die Prozesse in der Life Science Industrie in den kommenden Jahren stark ver\u00e4ndern. SAP spielt hier an vorderster Front und die neuen technologischen M\u00f6glichkeiten werden den Unternehmen laufend in den SAP-Produkten zur Verf\u00fcgung gestellt. <br \/>W\u00e4hrend die regulatorische Erwartung (Sicherstellung von Produktqualit\u00e4t, Patientensicherheit und Datenintegrit\u00e4t) gleichbleibt, ver\u00e4ndern sich die Anforderungen an die Validierungsans\u00e4tze rasch. Der Vortrag zeigte, wie Unternehmen diese neuen Herausforderungen erfolgreich meistern k\u00f6nnen: <strong>Risikobasierte Lieferantenbewertung und -auswahl mit Unterst\u00fctzung durch Audits und der GxP Cloud Control Matrix, kontinuierliche und automatisierte Validierung mit Hilfe einer End-to-End Digital Validation Platform.<\/strong><\/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":"36a8978a","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":"476ae73c","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":"77c8b949","elType":"widget","settings":{"title":"\u201cExciting times\u201c \u2013 aber mit neuen Compliance-Herausforderungen","_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":"19c47d6e","elType":"widget","settings":{"editor":"<p>Beim SAP Executive Exchange Forum for Life Sciences 2026 in Z\u00fcrich hielt Stefan Staub, Partner &amp; Principal Consultant der DHC Schweiz, den Vortrag <strong>\u201eSAP Innovation meets GxP Compliance \u2013 An Overview\u201c<\/strong>. Im Mittelpunkt stand eine Frage, die aktuell viele QA-, CSV- und IT-Teams besch\u00e4ftigt:<br \/><strong>Wie k\u00f6nnen Life-Sciences-Unternehmen SAP-Innovation (Private und Public Cloud SaaS L\u00f6sungen, KI-Anwendungen, \u2026) nutzen \u2013 ohne GxP-Compliance zu riskieren?<\/strong><\/p><h3>Aktuell zeigt sich dabei folgendes Spannungsfeld:<\/h3><p>Technologieanbieter treiben Innovation kontinuierlich voran, Unternehmen wollen und werden sie zeitnah nutzen \u2013 aber Gesetzgeber, Regulatoren ben\u00f6tigen Zeit, um Wissen zu generieren, dazugeh\u00f6rende Risiken zu identifizieren und entsprechende Gesetze und Leitlinien zu definieren. <br \/><br \/>QA\/CSV-Teams stehen dadurch h\u00e4ufig zwischen \u201etechnologisch m\u00f6glich\u201c und \u201eregulatorisch eindeutig geregelt\u201c.<\/p><ul><li>Die gute Nachricht: Die Ziele der Regulierung bleiben stabil: Sicherstellung von Produktqualit\u00e4t, Patientensicherheit und Datenintegrit\u00e4t.<\/li><li>Die herausfordernde Nachricht: Die technologischen Rahmenbedingungen ver\u00e4ndern sich schneller als je zuvor \u2013 und zwingen Unternehmen dazu, die Validierungsans\u00e4tze der neuen Realit\u00e4t, trotz noch fehlender Gesetze und Leitlinien und der damit verbunden Unsicherheit, anzupassen.<\/li><\/ul><p>Klassische, stark dokumentenzentrierte Validierungsans\u00e4tze aus \u201eWaterfallmodell-Zeiten\u201c geraten zunehmend an Grenzen, wenn sich die neuen IT-Systeme wie ein \u201eOrganismus\u201c permanent ver\u00e4ndern. <\/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":"2d114c7a","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":"2d945539","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":"7d3a6643","elType":"widget","settings":{"title":"Von \u201elinear &amp; dokumentenzentriert\u201c zu \u201econtinuous &amp; risikozentriert &amp; automatisiert\"","_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":"443d6ec9","elType":"widget","settings":{"editor":"<p>Viele Validierungsans\u00e4tze stammen aus einer Zeit, in der Software vergleichsweise <strong>statisch<\/strong> war. Entsprechend waren Ans\u00e4tze zur Computersystemvalidierung (CSV) stark <strong>dokumentationsgetrieben<\/strong>, teils sogar papierbasiert, linear entlang eines klassischen Wasserfallmodells. Das gilt in Teilen bis heute \u2013 wird aber zunehmend als zu langsam, b\u00fcrokratisch und teuer erlebt.<\/p><p>Das zentrale Bild: IT-Systeme verhalten sich heute eher wie ein <strong>\u201eOrganismus\u201c<\/strong>, der sich kontinuierlich ver\u00e4ndert: Cloud-Services, vor allem SaaS-Anwendungen und die damit verbundenen schnellen Release-Zyklen beschleunigen die \u00c4nderungsdynamik. Mit den aufkommenden KI-Anwendungen werden sich die Anforderungen weiter erh\u00f6hen.<\/p><p>Folglich muss sich die Validierung in Richtung einer kontinuierlichen Validierung <strong>(Continuous Validation)<\/strong> entwickeln. Rein manuell l\u00e4sst sich das Tempo, vor allem beim Change Impact Assessment und dem notwendigen Testen, nicht halten; Testautomatisierung wird zur Notwendigkeit (und perspektivisch k\u00f6nnen auch KI-Ans\u00e4tze Validierungsaktivit\u00e4ten unterst\u00fctzen).<\/p><p>In einer SAP-Landschaft, die von Cloud-Services, h\u00e4ufigen Releases und neuen KI-Anwendungen gepr\u00e4gt ist, m\u00fcssen Validierungsans\u00e4tze und Validierungswerkzeuge k\u00fcnftig daher folgende Eigenschaften erf\u00fcllen:<\/p><ul><li><strong>Schnell &amp; agil<\/strong>: Validierung muss mit neuen und schnellen Software-Entwicklungsmethoden und den damit verbundenen Release-Zyklen \u201emitlaufen\u201c \u2013 nicht nachgelagert bremsend und Innovations- und Effizienzpotenziale verhindernd.<\/li><li><strong>Automatisiert<\/strong>: Wiederkehrende Pr\u00fcf- und Dokumentationsschritte<br \/>m\u00fcssen industrialisiert werden (z. B. Change-Impact-Assessment auf Basis Release Notes, Regressionstests, Traceability,).<\/li><li><strong>Supplier-supported<\/strong>: In Cloud Computing, z.B. SaaS sind die Lieferanten aufgrund ihrer Verantwortlichkeiten und Kontrolle der Infrastruktur-, Plattform- und Softwareebene aktiv in die Qualifizierungs- und Validierungsaktivit\u00e4ten einzubinden.<\/li><li><strong>Kontinuierlich validierend<\/strong>: \u201eStay validated\u201c wird zum Betriebsmodell \u2013<br \/>mit klarer Governance, Change Impact Analysis und laufender<br \/>\u00dcberwachung statt punktueller Validierung mit periodischer \u00dcberpr\u00fcfung.<\/li><li><strong>Vollst\u00e4ndig digitalisiert<\/strong>: CSV-Aktivit\u00e4ten werden k\u00fcnftig vollst\u00e4ndig elektronisch in integrierten, workflowgesteuerten CSV-Tools (Tool-Chain) als strukturierte Daten statt in isolierten Dokumenten gesteuert. Dadurch wird die audit-sichere Dokumentation automatisiert erzeugt, Compliance und Transparenz steigen, w\u00e4hrend Aufwand und Durchlaufzeiten f\u00fcr Validierung und Freigabe GxP-relevanter Systeme sinken.<\/li><li><b>KI-unterst\u00fctzt<\/b>: KI kann unterst\u00fctzen, Informationen zu strukturieren, \u00c4nderungen vorzubereiten oder Reviews zu beschleunigen \u2013 ohne die regulatorische Verantwortung zu \u201edelegieren\u201c.<\/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":"start","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true}],"isInner":false},{"id":"4c1b62db","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":"40807610","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":"1d803162","elType":"widget","settings":{"title":"Cloud: \u201eShared responsibility\u201c \u2013  aber einseitige Accountability \/ Rechenschaftspflicht","_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":"213ab388","elType":"widget","settings":{"editor":"<p>Ein Kernpunkt im Cloud-Kontext l\u00e4sst sich in einem Satz zusammenfassen:<\/p><p>Viele Aufgaben liegen nicht mehr unter direkter Kontrolle des regulierten Unternehmens \u2013 <strong>die Rechenschaftspflicht bleibt aber bei ihm<\/strong>.<\/p><p>Dieses Spannungsfeld von geteilter Verantwortung bei gleichzeitig einseitiger Rechenschaftspflicht (\u201eshared responsibility but one-sided accountability\u201c) erkl\u00e4rt, warum <strong>Lieferantenauswahl und Lieferantenqualifizierung <\/strong>im Cloud-Kontext nicht \u201eNice to have\u201c, sondern ein Muss sind: Niemand m\u00f6chte erst nach Vertragsabschluss feststellen, dass ein Anbieter GxP-F\u00e4higkeiten oder Qualifizierungsunterst\u00fctzung nicht liefern kann \u2013 und dann in Audits\/Inspektionen ohne Nachweise dastehen. Daher gibt es regulatorische Anforderungen, die verlangen, dass man diesen Auswahl- und Assessment-Prozess durchf\u00fchrt, bevor man die Zusammenarbeit startet.<\/p><p>Die folgende Abbildung konkretisiert das entlang der Cloud-Service-Modelle (IaaS\/PaaS\/SaaS): Provider verantworten u. a. sicheren Betrieb, Change Management und Datenintegrit\u00e4t die regulierte Organisation muss nachweisen, dass der Provider die Anforderungen erf\u00fcllt (Qualification) und muss Anwendungen \u201efit for intended use\u201c validieren.<\/p><p><img class=\"aligncenter wp-image-15010 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/cloud-solutions.webp\" alt=\"Vergleich der Verantwortlichkeiten in Cloud-Modellen (On-Premises, IaaS, PaaS, SaaS) mit Verschiebung zum Anbieter, w\u00e4hrend die Gesamtverantwortung beim Unternehmen bleibt.\" width=\"1734\" height=\"907\" \/><\/p><p>Zum Assessment eignen sich folgende zwei Methoden mit ihren<br \/>Varianten:<\/p><h3><strong>Risikobasierte Cloud Service Provider Bewertung<\/strong><\/h3><p>Es gibt verschiedene\u00a0Wege um Cloud Service Provider (CSP) zu bewerten. Je nach Kritikalit\u00e4t der Applikation\/des\u00a0Lieferanten, sind unterschiedliche durchzuf\u00fchren.<\/p><p><img class=\"alignnone wp-image-15009 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/Risikobasierte-Cloud-Service-Provider-Bewertung.webp\" alt=\"\u00dcbersicht verschiedener Audit- und Bewertungsmethoden f\u00fcr Lieferanten (Assessment, Fragebogen, Audit) mit Vergleich von Aufwand, Einsatzbereich sowie Vor- und Nachteilen.\" width=\"1469\" height=\"851\" \/><\/p><h3><strong>GxP Cloud Control Matrix als strukturierter Nachweis<\/strong><\/h3><p>Basierend auf dem internationalen Standard der <strong>Cloud Controls Matrix<\/strong> der Cloud Security Alliance hat die DHC die GxP Cloud Control Matrix entwickelt, welche f\u00fcr Life Sciences Unternehmen um GxP-Anforderungen erweitert wurde (\u201eGxP-enhanced cloud control matrix\u201c). Die GxP CCM eignet sich ideal zur Bewertung von CSPs und als dokumentierter Nachweis, dass das geforderte Assessment durchgef\u00fchrt wurde.<\/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":"4bfe8fc","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":"6b289de0","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":"3afa1fcd","elType":"widget","settings":{"title":"Use Case:  Vertrauensaufbau zwischen  Cloud Service Provider (CSP) und reguliertem Unternehmen am Beispiel SAP Digital Manufacturing (SAP DM)","_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":"1653ea96","elType":"widget","settings":{"editor":"<p>Als Voraussetzung f\u00fcr eine erfolgreiche langfristige Zusammenarbeit zwischen reguliertem Unternehmen und Cloud Service Provider (CSP) m\u00fcssen beide Seiten ihre Hausaufgaben erledigen:<\/p><p><span style=\"text-decoration: underline;\"><strong>Reguliertes Unternehmen:<\/strong><\/span><\/p><ul><li>CSP Auswahl und Bewertung (siehe vorg\u00e4ngiger Abschnitt)<\/li><li>Vertragliche Regelung der Zusammenarbeit, dazu geh\u00f6ren:<ul><li>Master Service Agreement (MSA) und Service Level Agreement (SLA)s<\/li><li>Quality Assurance Agreement (QAA)<\/li><li>Data Processing Agreement (DPA)<\/li><li>\u2026<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">Hierbei sollte das Unternehmen darauf achten, dass es die M\u00f6glichkeit hat, beim CSP Audits durchzuf\u00fchren.<\/p><ul><li>\u00dcberwachung der Compliance und der Service Qualit\u00e4t des CSP \u00fcber die Dauer der Zusammenarbeit.<\/li><\/ul><p><span style=\"text-decoration: underline;\"><strong>SAP als Cloud Service Provider (CSP) f\u00fcr die SAP DM<\/strong><\/span><\/p><p>SAP muss sicherstellen, dass regulatorische und funktionale Anforderungen in der Life Science Industry sichergestellt werden. Der Kunde, das regulierte Unternehmen, braucht die Unterst\u00fctzung bei der Qualifizierung und Validierung durch die SAP. \u00a0Folgendes bietet die SAP im Falle der DM mit dem Quality Requirement Schedule f\u00fcr ihre GxP relevanten Kunden:<\/p><ul><li>Qualit\u00e4tssicherungsmassnahmen im Bereich Softwareentwicklung und -operations inkl.<ul><li>Qualit\u00e4tsmanagementsystem (QMS)<\/li><li>SOP f\u00fcr den SDLC (Softwareentwicklungszyklus)<\/li><li>Zertifizierungen und Bescheinigungen<\/li><li>GxP-Whitepapers (SAP DM &amp; SAP BTP)<\/li><li>Rahmenwerk f\u00fcr interne Audits und Kontrollen<\/li><\/ul><\/li><li>Qualifizierte SaaS-L\u00f6sung inkl.<ul><li>SAP-DM-Produktzertifizierung<\/li><li>SAP-BTP-Plattformzertifizierung<\/li><li>Zertifizierung f\u00fcr Continuous Platform Services<\/li><li>Matrix zur R\u00fcckverfolgbarkeit regulatorischer Anforderungen<\/li><li>Audit vor Ort auf Anfrage<\/li><\/ul><\/li><li>Konzept f\u00fcr den Betrieb inkl.<ul><li>Standardarbeitsanweisungen (SOP) f\u00fcr IT-Betrieb und Servicemanagement<\/li><li>Service Level Agreements (SLAs)<\/li><li>Release-Management<\/li><\/ul><\/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":"start","_flex_align_self":"center","text_columns":"1","column_gap":{"unit":"px","size":5,"sizes":[]}},"elements":[],"widgetType":"text-editor"}],"isInner":true},{"id":"6074539","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"20","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":"03f27d5","elType":"widget","settings":{"title":"Use Case: SaaS-Validierung am Beispiel SAP Digital Manufacturing (SAP DM)","_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":"2fbf431","elType":"widget","settings":{"editor":"<p>Erkenntnisse und Lehren aus der SAP DM Validierung:<\/p><ol><li><strong> SAP DM Systemarchitektur, -grenze und -funktionalit\u00e4t<\/strong><\/li><\/ol><p>SAP DM ist eine SaaS-L\u00f6sung auf der SAP Business Technology Platform (BTP als PaaS), welche auf einer Hyperscaler IaaS l\u00e4uft. F\u00fcr regulierte Organisationen bedeutet das: keine direkte Kontrolle \u00fcber das System (Stichwort: geteilte Verantwortlichkeiten), aber vollumf\u00e4ngliche Rechenschaftspflicht (siehe hierzu die vorg\u00e4ngigen Kapitel).<\/p><ol start=\"2\"><li><strong> Ein (noch) konventioneller Ansatz kann funktionieren \u2013 aber\u2026<\/strong><\/li><\/ol><p>Eine klassische, sich am GAMP5 orientierende und Dokumenten-basierte Validierung auf einem DMS kann durchaus gut funktionieren. Der eigentliche Engpass bei einem solchen Vorgehen zeigt sich beim Change Management, insbesondere beim Change Impact Assessment sowie beim Regressionstesten und da konkret im Binden der Business-Ressourcen.<\/p><p>Quartalsweise werden von SAP neue Releases eingespielt, welche in einem 2-w\u00f6chigen Testfenster getestet werden m\u00fcssen. Eine Woche bevor das Testfenster ge\u00f6ffnet wird, werden die Release Notes\u00a0 (What\u2019s New) publiziert. Es ergeben sich zwei Herausforderungen:<\/p><ul><li>Change Impact Assessment<br \/>Eine der grossen Herausforderungen im SaaS Umfeld ist die Interpretation der Release Notes und damit auch das Change Impact Assessment. Typischerweise werden die SAP DM What\u2019s New eine Woche vor dem Testfenster publiziert. Den regulierten Unternehmen bleibt eine Woche die Release Notes auszuwerten und den Impact auf die genutzten Funktionalit\u00e4ten und Prozesse zu bewerten.<\/li><\/ul><ul><li>Testen<br \/>Test- bzw. Regressionstestplanung, Ressourcenbereitstellung und das Ausf\u00fchren der Tests, ist f\u00fcr viele Organisationen ein grosser Aufwand. Gr\u00f6ssere Organisationen k\u00f6nnen hier teilweise auf Test Factories ausweichen, welche das Testen f\u00fcrs Business \u00fcbernehmen. Kleinere Organisation haben diese M\u00f6glichkeiten nicht, und \u00fcberstrapazieren das Business mit den Testaktivit\u00e4ten. Auf Dauer ist hier das manuelle Testen keine L\u00f6sung.<\/li><\/ul><p>Das praktische Fazit: Mit einem konventionellen Ansatz kann man validiert bleiben \u2013 <strong>aber<\/strong> man kann nicht alle paar Wochen dauerhaft die Fachbereiche mit manuellen Tests blockieren. Langfristig f\u00fchrt kein Weg vorbei an einer <strong>Testautomatisierung<\/strong> sowie einer Digitalisierung\/Automatisierung von Change Impact Analyse, Dokumentationspflege und Testing.<\/p><p>Damit wird Tool-Unterst\u00fctzung in der Validierung vom \u201enice-to-have\u201c zum Muss. Wenn Release Notes in kurzen Abst\u00e4nden bewertet, Changes sauber zugeordnet, Dokumente gepflegt, Tests geplant\/ausgef\u00fchrt und Nachweise auditf\u00e4hig abgelegt werden m\u00fcssen, l\u00e4sst sich das weder dauerhaft manuell noch rein dokumentenzentriert skalieren.<br \/>Entscheidend ist eine durchg\u00e4ngige Kette aus Change-Impact-Bewertung, Dokumentenpflege, (automatisiertem) Testen und automatischer Traceability \u2013 sonst wird die Continuous Validation zur Dauerbelastung f\u00fcr IT, Fachbereich und QA\/CSV-Organisation.<\/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},{"id":"10118c5","elType":"container","settings":{"content_width":"full","width":{"unit":"%","size":100,"sizes":[]},"background_background":"classic","margin":{"unit":"px","top":"20","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":"f27e77d","elType":"widget","settings":{"title":"SAP\u2019s Initiative zur End-2-End Digital Validation Platform","_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":"a75c708","elType":"widget","settings":{"editor":"<p>Viele Organisationen haben in den letzten Jahren den <strong>SAP Solution Manager<\/strong> (SolDoc, ChaRM, ITSM, Testmanagement, ggf. Focused Build mit Test Step Designer usw.) oder auch andere Werkzeuge als zentrales\u00a0<strong>Valdierungswerkzeug<\/strong> genutzt. Aber: Der SAP Solution Manager l\u00e4uft Richtung Supportende, man muss sich mit \u201eWhat\u2019s next\u201c besch\u00e4ftigen.<\/p><p>SAP positioniert <strong>Cloud ALM<\/strong> als Solution Manager Nachfolger, aber es kann und will nicht die eierlegende Wollmilchsau der Validierungswerkzeuge werden.<\/p><p>Daher setzt SAP zusammen mit mehreren SAP-Partnern in einer aktuellen Initiative zur End-2-End Digital Validation Platform auf eine <strong>integrierte Toolchain <\/strong>bestehend aus:<\/p><ul><li><strong>SAP LeanIX: <\/strong>f\u00fcrs Enterprise Architecture Management (EAM)<\/li><li><strong>Signavio<\/strong>: f\u00fcrs Business Process Managmenet (BPM). Aus Validierungssicht ist Signavio ein guter Einstieg f\u00fcr die Prozessdefinition und -modellierung<\/li><li><strong>SAP Cloud ALM:<\/strong> als Zentrum f\u00fcr Application Lifecycle Management (ALM) inkl. Transport Management, Test Management, Requirements Management usw.<\/li><li><strong>Tricentis Tosca:<\/strong> f\u00fcr automatisiertes Testen<\/li><li><strong>p36<\/strong><strong>: <\/strong>f\u00fcr die Continuous Service Qualification, besonders f\u00fcr BTP Services<\/li><li><strong>DHC Smart Validation Accelerator<\/strong> (SVA): f\u00fcr das Management von Validierungsobjekten, Changes- und Dokumenten. Als wichtiger erg\u00e4nzender Baustein f\u00fcr die <b>Validierungsdokumentation, Versionierung, elektronische Workflows, Sign-offs und Traceability.<br \/><\/b>Der Smart Validation Accelerator erm\u00f6glicht elektronisch und integriert die Erstellung und Ablage von z.B.:<ul><li>Validierungspl\u00e4nen<\/li><li>Validierungsobjekten und URS, FS, Risikoanalysen usw.<\/li><li>technische Dokumentationen<\/li><li>Testreports, Sign-offs, Validierungsreports<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">und steuert die integrierte Zusammenarbeit innerhalb der Toolchain.<\/p><p>Aktuell arbeitet DHC an der Fertigstellung des Change Impact Analyzers, um \u201eWhat\u2019s New\u201c \/ Release Notes zu interpretieren und risikobasierte Change Impact Assessments zu unterst\u00fctzen, um zu entscheiden, welche Validierungsobjekte\/Dokumente betroffen sind und was zu regressionstesten ist. Damit m\u00f6chte man dem engen Zeitfenster im SaaS-Release-Management begegnen.<\/p><p><img class=\"alignnone wp-image-15011 size-full\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/dhc-sva.webp\" alt=\"\" width=\"1672\" height=\"941\" 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