{"id":12571,"date":"2025-10-21T14:30:27","date_gmt":"2025-10-21T12:30:27","guid":{"rendered":"https:\/\/dhc.ima.vc\/validierung-von-ki-systemen-in-regulierten-branchen\/"},"modified":"2026-05-09T20:19:48","modified_gmt":"2026-05-09T18:19:48","slug":"validierung-von-ki-systemen-in-regulierten-branchen","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/ch\/validierung-von-ki-systemen-in-regulierten-branchen\/","title":{"rendered":"Validierung von KI-Systemen in regulierten Branchen \u2013 Forschungsbedarf, Regulierungsrahmen und Ausblick"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12571\" class=\"elementor elementor-12571 elementor-8656\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f897850 e-con-full e-flex e-con e-parent\" data-id=\"f897850\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ae80faa e-flex e-con-boxed e-con e-child\" data-id=\"ae80faa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-21d8f3a e-con-full e-flex e-con e-child\" data-id=\"21d8f3a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-68975e75 e-flex e-con-boxed e-con e-parent\" data-id=\"68975e75\" 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-6632343c e-con-full e-flex e-con e-child\" data-id=\"6632343c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5a193375 e-con-full e-flex e-con e-child\" data-id=\"5a193375\" 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-5a12a476 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"5a12a476\" 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\">Validierung von KI-Systemen in regulierten Branchen \u2013 Forschungsbedarf, Regulierungsrahmen und Ausblick<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-290b59c9 elementor-widget elementor-widget-text-editor\" data-id=\"290b59c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-testid=\"markdown-response\"><h3><em>Wenn KI selbst zum Compliance-Thema wird\u00a0<\/em><\/h3><p><span data-contrast=\"auto\">Wenn K\u00fcnstliche Intelligenz (KI) regulatorische Aufgaben \u00fcbernehmen kann, zur GxP- und IT-Compliance beitr\u00e4gt und zunehmend auch in Medizinprodukten Einzug h\u00e4lt, stellen sich zwangsl\u00e4ufig die Fragen: <\/span>Wie kann KI selbst validiert werden? <span data-contrast=\"auto\">Wie l\u00e4sst sich IT-Compliance von KI-Anwendungen herstellen und nachweisen?<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-27044818 elementor-author-box--align-left elementor-author-box--layout-image-left elementor-widget elementor-widget-author-box\" data-id=\"27044818\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/Thomas-Pauly-300x300.webp\" alt=\"Picture of Thomas Pauly, Practice Manager, DHC GmbH\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\t\t\t\t\t<div >\n\t\t\t\t\t\t<div class=\"elementor-author-box__name\">\n\t\t\t\t\t\t\tThomas Pauly, Practice Manager, DHC GmbH\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-5dccc47c e-con-full e-flex e-con e-child\" data-id=\"5dccc47c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7487dbfd elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"7487dbfd\" 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\/2025\/10\/validierung-ki.webp\" class=\"attachment-full size-full wp-image-15880\" alt=\"Wenn KI selbst zum Compliance-Thema wird\u00a0\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/10\/validierung-ki.webp 1200w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/10\/validierung-ki-300x88.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/10\/validierung-ki-1024x299.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/10\/validierung-ki-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-a2b663e e-flex e-con-boxed e-con e-parent\" data-id=\"a2b663e\" 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-58692cb6 e-con-full e-flex e-con e-child\" data-id=\"58692cb6\" 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-26b0f7ae elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"26b0f7ae\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Warum klassische Validierungsmethoden an Grenzen stossen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1d7c4767 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"1d7c4767\" 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><span data-contrast=\"auto\">F\u00fcr die Validierung von Softwaresystemen existieren seit Jahren etablierte regulatorische Methoden \u2013 etwa auf Basis der <\/span><b><span data-contrast=\"auto\">FDA-Guidelines<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">GxP-Richtlinien<\/span><\/b><span data-contrast=\"auto\">\u00a0oder der\u00a0<\/span><b><span data-contrast=\"auto\">IEC\u00a062304\u00a0f\u00fcr Medizinprodukte.\u00a0<\/span><\/b><span data-contrast=\"auto\">Diese Ans\u00e4tze funktionieren gut f\u00fcr Systeme, deren Verhalten\u00a0<\/span><b><span data-contrast=\"auto\">deterministisch, reproduzierbar und nachvollziehbar<\/span><\/b><span data-contrast=\"auto\">\u00a0ist.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">KI-basierte Systeme sind jedoch datengetrieben und probabilistisch. Sie ver\u00e4ndern ihre Leistungsf\u00e4higkeit durch neue Trainingsdaten \u2013 potenziell sogar aus Prozessen, die sie selbst beeinflussen.\u00a0F\u00fcr\u00a0solche\u00a0selbstlernenden Systeme\u00a0geraten klassische\u00a0Computerized\u00a0System Validation (CSV)-Methoden an ihre Grenzen.<\/span><\/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-167cbdf e-flex e-con-boxed e-con e-parent\" data-id=\"167cbdf\" 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-082bd80 e-con-full e-flex e-con e-child\" data-id=\"082bd80\" 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-e6264ee elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e6264ee\" 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\">Neue Anforderungen an Validierung und Compliance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8f389e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a8f389e\" 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><span data-contrast=\"auto\">Die Validierung von KI erfordert eine integrierte Betrachtung von<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><ul><li><span data-contrast=\"auto\">Datenqualit\u00e4t und -herkunft,<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">Modellarchitektur und Trainingsprozessen, sowie<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li><li><span data-contrast=\"auto\">dem Anwendungskontext, in den die KI eingebettet ist.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/li><\/ul><p><span data-contrast=\"auto\">Zwar enthalten bestehende Standards wie GAMP 5 Second Edition erste Ans\u00e4tze zur Validierung von\u00a0Machine\u00a0Learning-Systemen, sie reichen jedoch f\u00fcr vollst\u00e4ndig adaptive Systeme noch nicht aus.\u00a0Damit entsteht die Gefahr, dass Regulierung zur Innovationsbremse wird.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Dies betrifft sowohl den Einsatz von KI in Medizinprodukten (\u201eAI\u00a0as\u00a0a\u00a0medical\u00a0device\u201c) als auch KI-basierte Systeme zur Unterst\u00fctzung von Gesch\u00e4fts-, Produktions-\u00a0oder Qualit\u00e4tsprozessen.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/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-a2ab0fa e-flex e-con-boxed e-con e-parent\" data-id=\"a2ab0fa\" 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-aea7474 e-con-full e-flex e-con e-child\" data-id=\"aea7474\" 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-7029243 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"7029243\" 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\">Fehlende Standards als Innovationshemmnis<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d536119 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"d536119\" 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><span data-contrast=\"auto\">In\u00a0diesen\u00a0Bereichen entwickelt sich die Digitalisierung rasant, doch es fehlen geeignete Methoden und\u00a0Erfahrungen, um IT-Compliance nachvollziehbar\u00a0nachzuweisen. Fehlende regulatorische Orientierung und daraus resultierende Unsicherheit k\u00f6nnen sich zu einem Hemmnis f\u00fcr Innovationsf\u00e4higkeit und unternehmerischen Erfolg entwickeln \u2013 und das ausgerechnet in volkswirtschaftlich bedeutenden,\u00a0oft\u00a0mittelst\u00e4ndisch gepr\u00e4gten Branchen wie\u00a0Pharma, Biotechnologie und Medizintechnik.\u00a0Vor diesem Hintergrund besteht\u00a0<\/span><b><span data-contrast=\"auto\">methodischer und technologischer\u00a0Entwicklungsbedarf<\/span><\/b><span data-contrast=\"auto\">\u00a0zur Validierung von KI-Systemen.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Den \u00fcbergeordneten Rahmen f\u00fcr die weitere Entwicklung setzen insbesondere die\u00a0<\/span><b><span data-contrast=\"auto\">aktuellen europ\u00e4ischen Regelungen zur Datenverarbeitung und K\u00fcnstlichen Intelligenz<\/span><\/b><span data-contrast=\"auto\">. Hierzu z\u00e4hlen der\u00a0<\/span><b><span data-contrast=\"auto\">Data Act<\/span><\/b><span data-contrast=\"auto\">\u00a0(Juni 2023), der\u00a0<\/span><b><span data-contrast=\"auto\">Data\u00a0Governance\u00a0Act (DGA)<\/span><\/b><span data-contrast=\"auto\">\u00a0(September 2023) sowie der\u00a0<\/span><b><span data-contrast=\"auto\">EU AI Act<\/span><\/b><span data-contrast=\"auto\">, der die weltweit erste umfassende Regulierung von K\u00fcnstlicher Intelligenz anstrebt. K\u00fcnftige Ans\u00e4tze zur Validierung von KI m\u00fcssen sich in diesen Rechtsrahmen einf\u00fcgen. Parallel dazu existieren internationale Initiativen, die branchenspezifische Regulierungen f\u00fcr KI entwickeln \u2013 etwa von der\u00a0EMA\u00a0oder\u00a0der\u00a0FDA.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Allerdings konzentrieren sich diese bisher vorrangig auf\u00a0die regulatorischen Anforderungen\u00a0f\u00fcr die Entwicklung von KI-basierten Systemen. F\u00fcr deren\u00a0<\/span><b><span data-contrast=\"auto\">Betrieb<\/span><\/b><span data-contrast=\"auto\">\u00a0\u2013 und damit auch f\u00fcr die Frage der\u00a0<\/span><b><span data-contrast=\"auto\">Validierung und IT-Compliance<\/span><\/b><span data-contrast=\"auto\"> \u2013 existieren bislang keine abschliessenden Antworten. Offene Fragen lauten<\/span><\/p><ul><li><span data-contrast=\"auto\">Wie beeinflusst KI die Inspektionspraxis der \u00dcberwachungsbeh\u00f6rden?<\/span><\/li><li><span data-contrast=\"auto\">Welcher Anpassungsbedarf entsteht f\u00fcr bestehende CSV-Methoden?<\/span><\/li><li><span data-contrast=\"auto\">Wie kann die geforderte\u00a0Compliance von KI-Systemen nachgewiesen werden?<\/span><\/li><\/ul><p>Diese Fragen verdeutlichen die bestehende L\u00fccke: Es fehlt ein verl\u00e4ssliches Regelwerk, das CSV und KI-Validierung systematisch miteinander verbindet. Ebenso fehlen standardisierte Methoden und technologische Werkzeuge, um KI-Systeme unter geltenden Regularien nachvollziehbar zu pr\u00fcfen.<\/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-7a95efa e-flex e-con-boxed e-con e-parent\" data-id=\"7a95efa\" 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-dccc3c9 e-con-full e-flex e-con e-child\" data-id=\"dccc3c9\" 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-4306dab elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"4306dab\" 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\">Der kommende Annex 22:<br> Ein Schritt zur Schliessung der L\u00fccke?\u00a0<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8020aab elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"8020aab\" 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><span data-contrast=\"auto\">Der im Entwurf befindliche\u00a0<\/span><b><span data-contrast=\"auto\">Annex 22 \u201eArtificial\u00a0Intelligence\u201c<\/span><\/b><span data-contrast=\"auto\">\u00a0soll k\u00fcnftig genau diese L\u00fccke schliessen. Er erg\u00e4nzt\u00a0<\/span><b><span data-contrast=\"auto\">Annex 11 \u201eComputerised\u00a0Systems\u201c<\/span><\/b><span data-contrast=\"auto\">\u00a0und adressiert die Validierung von KI-Modellen in GMP-kritischen Anwendungen. Sein Geltungsbereich umfasst\u00a0Machine-Learning-Modelle, die ihre Funktionalit\u00e4t durch Training mit Daten erlangen, nicht durch fest einprogrammierte Regeln. Annex 22 legt fest, dass ausschliesslich\u00a0<\/span><b><span data-contrast=\"auto\">statische Modelle<\/span><\/b><span data-contrast=\"auto\">, also Modelle mit eingefrorenen Parametern, in kritischen GMP-Anwendungen eingesetzt werden d\u00fcrfen, da diese\u00a0Parameter\u00a0f\u00fcr die Herstellungsprozesse\u00a0(CPPs)\u00a0sowie\u00a0die entsprechenden\u00a0Attribute\u00a0in der\u00a0Qualit\u00e4tskontrolle\u00a0(CQAs)\u00a0meistens im\u00a0Zulassungsdossier des Arzneimittels\u00a0festgelegt sind und nicht ver\u00e4ndert werden d\u00fcrfen.\u00a0<\/span><b><span data-contrast=\"auto\">Dynamische oder generative Modelle<\/span><\/b><span data-contrast=\"auto\">, die sich nach ihrer Freigabe selbst weiterentwickeln, sind in diesem Kontext\u00a0daher\u00a0ausdr\u00fccklich ausgeschlossen.\u00a0Dar\u00fcber hinaus beschreibt der Entwurf Anforderungen an\u00a0<\/span><b><span data-contrast=\"auto\">Testdaten<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">Erkl\u00e4rbarkeit<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">Vertrauensniveaus<\/span><\/b><span data-contrast=\"auto\">,\u00a0<\/span><b><span data-contrast=\"auto\">Change Control<\/span><\/b><span data-contrast=\"auto\">\u00a0und\u00a0<\/span><b><span data-contrast=\"auto\">Human-in-the-Loop-Prinzipien<\/span><\/b><span data-contrast=\"auto\">. Ziel ist es, sicherzustellen, dass KI-Modelle nur dort eingesetzt werden, wo ihre Leistungsf\u00e4higkeit, Stabilit\u00e4t und Nachvollziehbarkeit mit\u00a0den\u00a0GMP-Anforderungen vereinbar sind.\u00a0<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Damit entsteht erstmals ein Rahmen, der den Einsatz von KI in regulierten Umgebungen erm\u00f6glicht, ohne die Grundprinzipien von Patientensicherheit, Produktqualit\u00e4t und Datenintegrit\u00e4t zu gef\u00e4hrden.<\/span><\/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-16e35b4 e-flex e-con-boxed e-con e-parent\" data-id=\"16e35b4\" 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-3f8ed73 e-con-full e-flex e-con e-child\" data-id=\"3f8ed73\" 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-007dd55 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"007dd55\" 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\u00a0<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cc5cabe elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"cc5cabe\" 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><span data-contrast=\"auto\">Die Validierung von KI-Systemen steht an der Schnittstelle von technologischer Innovation und regulatorischer Verantwortung. Sie ist derzeit eines der dynamischsten und zugleich am wenigsten standardisierten Themen im Life-Sciences-Sektor. Zwischen klassischen CSV-Methoden und modernen, datengetriebenen Systemen klafft eine L\u00fccke, die neue Methoden, neue Denkweisen und neue Werkzeuge erfordert.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Mit dem EU AI Act entsteht erstmals ein Rechtsrahmen, der den Einsatz von KI in allen Sektoren adressiert. Der Annex 22 \u201eArtificial\u00a0Intelligence\u201c konkretisiert diesen Rahmen f\u00fcr GMP-regulierte Umgebungen und schafft die Basis f\u00fcr eine nachvollziehbare, risikobasierte Validierung von KI-Modellen. Damit werden regulatorische Leitplanken gesetzt, die Innovation erm\u00f6glichen, ohne die Grundprinzipien von Patientensicherheit, Produktqualit\u00e4t und Datenintegrit\u00e4t zu gef\u00e4hrden.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">F\u00fcr Unternehmen bedeutet das: Sie\u00a0sollten\u00a0sich fr\u00fchzeitig mit den neuen Anforderungen auseinandersetzen, ihre\u00a0Validierungsstrategien\u00a0anpassen und\u00a0interne Kompetenzen f\u00fcr die Bewertung von KI-Systemen aufbauen. Nur wer diesen Wandel aktiv gestaltet, kann sicherstellen, dass K\u00fcnstliche Intelligenz nicht zum Compliance-Risiko wird, sondern zum Innovationstreiber in regulierten Branchen.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-ccp-props=\"{}\"><a style=\"font-size: 16px; line-height: inherit; transition-duration: 0.3s; font-weight: bold; text-align: center; background-color: #ffffff;\" href=\"https:\/\/dhc.ima.vc\/ki-validierung\/\">\u2192 Mehr zur Validierung von KI-Systemen<\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1aac793a e-flex e-con-boxed e-con e-child\" data-id=\"1aac793a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41223ab3 e-con-full e-flex e-con e-child\" data-id=\"41223ab3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1117cb89 e-con-full e-flex e-con e-child\" data-id=\"1117cb89\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7571e62 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"7571e62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Validierung von KI-Systemen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fc7341d elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1fc7341d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-testid=\"markdown-response\"><div data-testid=\"markdown-response\"><p id=\"message\">Lassen Sie uns gemeinsam anschauen, wie Ihre KI-Pl\u00e4ne zu EU AI Act und Annex 22 passen.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b9cfc72 elementor-mobile-align-center custom-button elementor-widget elementor-widget-button\" data-id=\"4b9cfc72\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dhc.ima.vc\/termin-vereinbaren\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-arrow-right\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M190.5 66.9l22.2-22.2c9.4-9.4 24.6-9.4 33.9 0L441 239c9.4 9.4 9.4 24.6 0 33.9L246.6 467.3c-9.4 9.4-24.6 9.4-33.9 0l-22.2-22.2c-9.5-9.5-9.3-25 .4-34.3L311.4 296H24c-13.3 0-24-10.7-24-24v-32c0-13.3 10.7-24 24-24h287.4L190.9 101.2c-9.8-9.3-10-24.8-.4-34.3z\"><\/path><\/svg>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Jetzt unverbindliches 1:1-Expertengespr\u00e4ch vereinbaren<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-293cbc43 e-con-full e-flex e-con e-child\" data-id=\"293cbc43\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68de9688 elementor-author-box--image-valign-middle elementor-widget elementor-widget-author-box\" data-id=\"68de9688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/05\/valeria_ratter.jpg\" alt=\"Author picture\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-525d8085 e-flex e-con-boxed e-con e-parent\" data-id=\"525d8085\" 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-6b28ef0 elementor-widget elementor-widget-heading\" data-id=\"6b28ef0\" 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-734298f5 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"734298f5\" 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 zur KI-Validierung im regulierten Umfeld<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7943a845 e-con-full e-flex e-con e-child\" data-id=\"7943a845\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fca2070 elementor-widget__width-initial elementor-widget elementor-widget-n-accordion\" data-id=\"5fca2070\" 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-1600\" 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-1600\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Warum stossen klassische CSV-Methoden bei KI an Grenzen? <\/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-1600\" class=\"elementor-element elementor-element-645feb2a e-con-full e-flex e-con e-child\" data-id=\"645feb2a\" 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-1600\" class=\"elementor-element elementor-element-72d410a6 e-flex e-con-boxed e-con e-child\" data-id=\"72d410a6\" 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-1d477fce elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1d477fce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\nKlassische Validierungsmethoden setzen deterministisches, reproduzierbares Systemverhalten voraus. KI- und Machine-Learning-Modelle sind dagegen datengetrieben und probabilistisch, ver\u00e4ndern ihre Performance mit neuen Trainingsdaten und k\u00f6nnen Prozesse beeinflussen, aus denen sie wiederum lernen \u2013 dadurch greifen klassische CSV-Ans\u00e4tze nur begrenzt.\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-1601\" 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-1601\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche zus\u00e4tzlichen Anforderungen stellt KI an Validierung und Compliance <\/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-1601\" class=\"elementor-element elementor-element-7ea4ceca e-con-full e-flex e-con e-child\" data-id=\"7ea4ceca\" 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-1601\" class=\"elementor-element elementor-element-10d7f155 e-flex e-con-boxed e-con e-child\" data-id=\"10d7f155\" 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-27d363f4 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"27d363f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tNeben der Software selbst m\u00fcssen Datenqualit\u00e4t und -herkunft, Modellarchitektur, Trainingsprozesse und der konkrete Anwendungskontext bewertet werden. Es geht um Fragen wie: Woher stammen die Daten, wie wird das Modell trainiert, wie stabil ist das Verhalten im Zielprozess und wie wird der Einsatz gegen\u00fcber Beh\u00f6rden nachvollziehbar dokumentiert?\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-1602\" 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-1602\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Welche Rolle spielen EU AI Act und Annex 22 \u201eArtificial Intelligence\u201c? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_640_2835)\"><\/rect><path d=\"M20.3768 15.385V17.156H11.1998V15.385H20.3768Z\" fill=\"#006A61\"><\/path><defs><linearGradient id=\"paint0_linear_640_2835\" x1=\"-7.38418\" y1=\"-12.96\" x2=\"100.048\" y2=\"-18.3067\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.25\" stop-color=\"#EEEEEE\"><\/stop><stop offset=\"0.841214\" stop-color=\"#006A61\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"33\" height=\"33\" viewBox=\"0 0 33 33\" fill=\"none\"><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint0_linear_641_2844)\" fill-opacity=\"0.5\"><\/rect><rect width=\"32.4\" height=\"32.4\" rx=\"16.2\" fill=\"url(#paint1_linear_641_2844)\" fill-opacity=\"0.7\"><\/rect><path d=\"M22.0807 17.179H17.1817V22.147H15.2267V17.179H10.3507V15.408H15.2267V10.4169H17.1817V15.408H22.0807V17.179Z\" fill=\"white\"><\/path><defs><linearGradient id=\"paint0_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_641_2844\" x1=\"-7.38419\" y1=\"-12.96\" x2=\"77.0515\" y2=\"-14.0178\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1602\" class=\"elementor-element elementor-element-4faeac5d e-con-full e-flex e-con e-child\" data-id=\"4faeac5d\" 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-1602\" class=\"elementor-element elementor-element-44bfb15c e-flex e-con-boxed e-con e-child\" data-id=\"44bfb15c\" 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-2344e419 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"2344e419\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tDer EU AI Act schafft einen allgemeinen Rechtsrahmen f\u00fcr KI in Europa. Annex 22 erg\u00e4nzt Annex 11 gezielt f\u00fcr GMP-regulierte KI-Anwendungen und definiert Anforderungen an statische Modelle, Testdaten, Erkl\u00e4rbarkeit, Vertrauensniveaus, Change Control und Human-in-the-Loop. Damit entsteht erstmals ein spezifischer Rahmen f\u00fcr KI-Validierung in GMP-kritischen Prozessen.\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-1603\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1603\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Warum sind dynamische oder generative KI-Modelle in GMP-kritischen Anwendungen problematisch? <\/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-1603\" class=\"elementor-element elementor-element-63fb40b3 e-con-full e-flex e-con e-child\" data-id=\"63fb40b3\" 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-1603\" class=\"elementor-element elementor-element-163c11fb e-flex e-con-boxed e-con e-child\" data-id=\"163c11fb\" 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-4a94e734 elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"4a94e734\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\nIn GMP-Umgebungen sind kritische Prozessparameter (CPPs) und Qualit\u00e4tsattribute (CQAs) im Zulassungsdossier festgelegt und d\u00fcrfen nicht ohne Weiteres ver\u00e4ndert werden. Dynamische oder generative Modelle, die sich nach der Freigabe selbst weiterentwickeln, w\u00fcrden diese Stabilit\u00e4t untergraben und sind daher im aktuellen Annex\u201122-Entwurf ausdr\u00fccklich ausgeschlossen.\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-1604\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1604\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Was sollten Life-Sciences-Unternehmen jetzt tun? <\/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-1604\" class=\"elementor-element elementor-element-7fba1194 e-con-full e-flex e-con e-child\" data-id=\"7fba1194\" 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-1604\" class=\"elementor-element elementor-element-66714355 e-flex e-con-boxed e-con e-child\" data-id=\"66714355\" 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-385c843a elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"385c843a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\tUnternehmen sollten fr\u00fchzeitig ihre Validierungsstrategie f\u00fcr KI \u00fcberpr\u00fcfen, Verantwortlichkeiten kl\u00e4ren, Kompetenzen f\u00fcr die Bewertung von KI-Modellen aufbauen und regulatorische Entwicklungen (EU AI Act, Annex 22, FDA-\/EMA-Initiativen) aktiv verfolgen. Ziel ist es, KI gezielt als Innovationstreiber zu nutzen, ohne neue Compliance-Risiken zu erzeugen.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-643854bd e-flex e-con-boxed e-con e-parent\" data-id=\"643854bd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fd289b3 elementor-widget elementor-widget-heading\" data-id=\"4fd289b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">Magazin<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52106f4c elementor-widget elementor-widget-heading\" data-id=\"52106f4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Weitere Artikel aus dem Blog<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25940306 elementor-grid-tablet-1 elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"25940306\" data-element_type=\"widget\" data-e-type=\"widget\" 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.elementor-element.elementor-element-adf3d07{--min-height:0px;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}\/* Start custom CSS for container, class: .elementor-element-adf3d07 *\/.elementor-2842 .elementor-element.elementor-element-adf3d07{\n    position: relative;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .icon-more-posts{\n    position: absolute;\n    bottom: 20px;\n    left: 0;\n    right: 0;\n    opacity: 0;\n    transform: translateY(8px);\n    transition: opacity 0.3s ease, transform 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .icon-more-posts{\n    opacity: 1;\n    transform: translateY(0);\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .loop-post-excerpt{\n    padding-bottom: 0;\n    transition: padding-bottom 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .loop-post-excerpt{\n    padding-bottom: 70px;\n}\/* End custom CSS *\/<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-16122 post-16122 post type-post status-publish format-standard has-post-thumbnail hentry category-gxp-compliance-csv tag-cloud-validierung tag-public-cloud-validierung\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/ch\/sap-innovation-trifft-gxp-compliance\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SAP-Innovation trifft auf GxP-Compliance<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tWie ver\u00e4ndern Cloud, SaaS, AI &amp; h\u00e4ufige Releases die Validierung?\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-12543 post-12543 post type-post status-publish format-standard has-post-thumbnail hentry category-sap-qualitaetsmanagement tag-qm-mit-sap tag-sap-qim tag-sap-qm\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/ch\/sap-qim-support-ende-und-abloesung\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">SAP QIM Support-Ende 2027: Warum Unternehmen jetzt handeln sollten<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tSAP QIM Support endet 2027: Erfahren Sie, welche Risiken entstehen und warum sich eine fr\u00fchzeitige Migration zu QM in S\/4HANA\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-12545 post-12545 post type-post status-publish format-standard has-post-thumbnail hentry category-gxp-compliance-csv\" data-elementor-post-type=\"elementor_library\" data-custom-edit-handle=\"1\">\n\t\t\t<a class=\"elementor-element elementor-element-adf3d07 e-con-full e-transform e-flex e-con e-child\" data-id=\"adf3d07\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_transform_scale_effect_hover&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:1.03,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;_transform_scale_effect_hover_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" href=\"https:\/\/dhc.ima.vc\/ch\/gxp-friendly-audit-fuer-saas-plattform\/\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dc3b08a elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"dc3b08a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">GxP-Friendly Audit f\u00fcr Ledidi Trials \u2013 SaaS-Plattform f\u00fcr regulierte klinische Studien<\/div>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8da389e elementor-widget elementor-widget-theme-post-excerpt\" data-id=\"8da389e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-excerpt.default\">\n\t\t\t\t\tIm Rahmen eines unabh\u00e4ngigen GxP-Friendly Audits wurde die SaaS-Plattform Ledidi Trials durch DHC umfassend bewertet.\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2511066 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"2511066\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"54\" height=\"54\" viewBox=\"0 0 54 54\" fill=\"none\"><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint0_linear_1116_572)\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"url(#paint1_linear_1116_572)\" fill-opacity=\"0.9\"><\/rect><rect width=\"54\" height=\"54\" rx=\"27\" fill=\"#0AA236\"><\/rect><path d=\"M21.25 27H32.75M32.75 27L27.75 22M32.75 27L27.75 32\" stroke=\"#FEFEFE\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><\/path><defs><linearGradient id=\"paint0_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#006A61\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><linearGradient id=\"paint1_linear_1116_572\" x1=\"-12.307\" y1=\"-21.6001\" x2=\"128.419\" y2=\"-23.3629\" gradientUnits=\"userSpaceOnUse\"><stop offset=\"0.158786\" stop-color=\"#0AA236\"><\/stop><stop offset=\"1\" stop-color=\"#F1FDFE\"><\/stop><\/linearGradient><\/defs><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>KI wird selbst zum Compliance-Thema: Wie l\u00e4sst sich K\u00fcnstliche Intelligenz validieren und regulatorisch absichern? Erfahren Sie mehr zu Annex 22 &#038; EU AI Act.<\/p>\n","protected":false},"author":4,"featured_media":15880,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[99],"tags":[128],"class_list":["post-12571","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gxp-compliance-csv","tag-it-compliance"],"acf":[],"yoast_title":"Validierung von KI-Systemen in regulierten Branchen","yoast_metadesc":"KI wird selbst zum Compliance-Thema: Wie l\u00e4sst sich K\u00fcnstliche Intelligenz validieren und regulatorisch absichern? Erfahren Sie mehr zu Annex 22 & EU AI 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Hierzu z\u00e4hlen der\u00a0<\/span><b><span data-contrast=\"auto\">Data Act<\/span><\/b><span data-contrast=\"auto\">\u00a0(Juni 2023), der\u00a0<\/span><b><span data-contrast=\"auto\">Data\u00a0Governance\u00a0Act (DGA)<\/span><\/b><span data-contrast=\"auto\">\u00a0(September 2023) sowie der\u00a0<\/span><b><span data-contrast=\"auto\">EU AI Act<\/span><\/b><span data-contrast=\"auto\">, der die weltweit erste umfassende Regulierung von K\u00fcnstlicher Intelligenz anstrebt. K\u00fcnftige Ans\u00e4tze zur Validierung von KI m\u00fcssen sich in diesen Rechtsrahmen einf\u00fcgen. Parallel dazu existieren internationale Initiativen, die branchenspezifische Regulierungen f\u00fcr KI entwickeln \u2013 etwa von der\u00a0EMA\u00a0oder\u00a0der\u00a0FDA.<\/span><span data-ccp-props=\"{}\">\u00a0<\/span><\/p><p><span data-contrast=\"auto\">Allerdings konzentrieren sich diese bisher vorrangig auf\u00a0die regulatorischen Anforderungen\u00a0f\u00fcr die Entwicklung von KI-basierten Systemen. 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