{"id":12570,"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":"2026-05-09T23:51:36","modified_gmt":"2026-05-09T21:51:36","slug":"validation-of-ai-systems-in-regulated-industries","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/en\/validation-of-ai-systems-in-regulated-industries\/","title":{"rendered":"Validation of AI Systems in regulated Industries: Research needs, regulatory framework and Outlook"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12570\" class=\"elementor elementor-12570 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\">Validation of AI Systems in regulated Industries: Research needs, regulatory framework and Outlook<\/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>When AI itself becomes a compliance topic <\/em><\/h3><p><span data-contrast=\"auto\">When artificial intelligence (AI) can take on regulatory tasks, contributes to GxP and IT compliance, and is increasingly being integrated into medical devices, the following questions inevitably arise: <\/span>How can AI itself be validated? <span data-contrast=\"auto\">How can IT compliance of AI applications be established and demonstrated?<\/span><span data-ccp-props=\"{}\"> <\/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-13558\" 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\">Why Traditional Validation Methods Reach Their Limits<\/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\">Established regulatory methods for software system validation have existed for years, based for example on <\/span><b><span data-contrast=\"auto\">FDA guidelines<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">GxP regulations<\/span><\/b><span data-contrast=\"auto\">, or <\/span><b><span data-contrast=\"auto\">IEC 62304 for medical devices. <\/span><\/b><span data-contrast=\"auto\">These approaches work well for systems whose behavior is <\/span><b><span data-contrast=\"auto\">deterministic, reproducible, and traceable<\/span><\/b><span data-contrast=\"auto\">.<\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">AI-based systems, however, are data-driven and probabilistic. They change their performance through new training data, potentially even from processes they themselves influence. For such self-learning systems, classical Computerized System Validation (CSV) methods reach their limits.<\/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\">New Requirements for Validation and 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\">The validation of AI requires an integrated consideration of<\/span><span data-ccp-props=\"{}\"> <\/span><\/p><ul><li><span data-contrast=\"auto\">data quality and provenance,<\/span><span data-ccp-props=\"{}\"> <\/span><\/li><li><span data-contrast=\"auto\">model architecture and training processes, as well as<\/span><span data-ccp-props=\"{}\"> <\/span><\/li><li><span data-contrast=\"auto\">the application context in which the AI is embedded.<\/span><span data-ccp-props=\"{}\"> <\/span><\/li><\/ul><p><span data-contrast=\"auto\">While existing standards such as GAMP 5 Second Edition contain initial approaches to validating machine learning systems, they are not yet sufficient for fully adaptive systems. This creates the risk that regulation becomes a brake on innovation. <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">This applies both to the use of AI in medical devices (&#8220;AI as a medical device&#8221;) and AI-based systems supporting business, production, or quality processes.<\/span><span data-ccp-props=\"{}\"> <\/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\">Missing Standards as Innovation Barrier<\/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 these areas, digitalization is advancing rapidly, yet there is a lack of suitable methods and experience to demonstrably prove IT compliance. Missing regulatory guidance and the resulting uncertainty can become an obstacle to innovation capability and business success, particularly in economically significant, often mid-sized industries such as pharmaceuticals, biotechnology and medical technology. Against this background, there is <\/span><b><span data-contrast=\"auto\">a need for methodological and technological development<\/span><\/b><span data-contrast=\"auto\"> in the validation of AI systems. <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">The overarching framework for further development is set in particular by <\/span><b><span data-contrast=\"auto\">current European regulations on data processing and artificial intelligence<\/span><\/b><span data-contrast=\"auto\">. These include the <\/span><b><span data-contrast=\"auto\">Data Act<\/span><\/b><span data-contrast=\"auto\"> (June 2023), the <\/span><b><span data-contrast=\"auto\">Data Governance Act (DGA)<\/span><\/b><span data-contrast=\"auto\"> (September 2023) and the <\/span><b><span data-contrast=\"auto\">EU AI Act<\/span><\/b><span data-contrast=\"auto\">, which aims to be the world&#8217;s first comprehensive regulation of artificial intelligence. Future approaches to AI validation must fit within this legal framework. In parallel, there are international initiatives developing industry-specific regulations for AI, for example from the EMA or the FDA.<\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">However, these have so far focused primarily on the regulatory requirements for the development of AI-based systems. For their <\/span><b><span data-contrast=\"auto\">operation<\/span><\/b><span data-contrast=\"auto\">, and consequently also for the question of <\/span><b><span data-contrast=\"auto\">validation and IT compliance<\/span><\/b><span data-contrast=\"auto\">, no definitive answers exist to date. Open questions include:<\/span><\/p><ul><li><span data-contrast=\"auto\">How does AI influence the inspection practices of regulatory authorities?<\/span><\/li><li><span data-contrast=\"auto\">What adjustments are needed for existing CSV methods?<\/span><\/li><li><span data-contrast=\"auto\">How can the required compliance of AI systems be demonstrated?<\/span><\/li><\/ul><p>These questions highlight the existing gap: there is no reliable regulatory framework that systematically connects CSV and AI validation. Likewise, standardized methods and technological tools for verifiably testing AI systems under current regulations are missing.<\/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\">The upcoming Annex 22:<br> A step toward closing the gap?&nbsp;<\/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\">The draft <\/span><b><span data-contrast=\"auto\">Annex 22 &#8220;Artificial Intelligence&#8221;<\/span><\/b><span data-contrast=\"auto\"> is intended to close precisely this gap in the future. It complements <\/span><b><span data-contrast=\"auto\">Annex 11 &#8220;Computerised Systems&#8221;<\/span><\/b><span data-contrast=\"auto\"> and addresses the validation of AI models in GMP-critical applications. Its scope covers machine learning models that acquire their functionality through training with data, not through hard-coded rules. Annex 22 stipulates that only <\/span><b><span data-contrast=\"auto\">static models<\/span><\/b><span data-contrast=\"auto\">, i.e. models with frozen parameters, may be used in critical GMP applications, since these parameters for the manufacturing processes (CPPs) and the corresponding attributes in quality control (CQAs) are usually defined in the medicinal product&#8217;s marketing authorization dossier and may not be changed. <\/span><b><span data-contrast=\"auto\">Dynamic or generative models<\/span><\/b><span data-contrast=\"auto\"> that continue to evolve after their release are therefore explicitly excluded in this context. Furthermore, the draft describes requirements for <\/span><b><span data-contrast=\"auto\">test data<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">explainability<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">confidence levels<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">change control<\/span><\/b><span data-contrast=\"auto\"> and <\/span><b><span data-contrast=\"auto\">human-in-the-loop principles<\/span><\/b><span data-contrast=\"auto\">. The goal is to ensure that AI models are only deployed where their performance, stability and traceability are compatible with GMP requirements. <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">This creates, for the first time, a framework that enables the use of AI in regulated environments without jeopardizing the fundamental principles of patient safety, product quality and data integrity.<\/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\">Conclusion<\/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\">The validation of AI systems stands at the intersection of technological innovation and regulatory responsibility. It is currently one of the most dynamic and at the same time least standardized topics in the life sciences sector. Between classical CSV methods and modern, data-driven systems, there is a gap that requires new methods, new ways of thinking, and new tools.<\/span><\/p><p><span data-contrast=\"auto\">With the EU AI Act, a legal framework is being created for the first time that addresses the use of AI across all sectors. Annex 22 &#8220;Artificial Intelligence&#8221; concretizes this framework for GMP-regulated environments and creates the basis for traceable, risk-based validation of AI models. This sets regulatory guardrails that enable innovation without jeopardizing the fundamental principles of patient safety, product quality, and data integrity.<\/span><\/p><p><span data-contrast=\"auto\">For companies, this means: They should engage with the new requirements early, adapt their validation strategies, and build internal competencies for assessing AI systems. Only those who actively shape this transformation can ensure that artificial intelligence does not become a compliance risk but rather an innovation driver in regulated industries.<\/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\/en\/gxp-compliance\/ai-validation\/\">\u2192 More about AI system validation<\/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\">Validation of AI Systems<\/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\">Let us jointly review how your AI plans align with the EU AI Act and Annex 22.<\/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\/en\/book-meeting\/\">\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\">Book a free Initial Consultation<\/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\/03\/karsten-schulz-dhc-experte-300x300.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-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\">Magazine<\/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\">More Articles from the Blog<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25940306 elementor-grid-tablet-1 elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"25940306\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;template_id&quot;:2842,&quot;columns_tablet&quot;:1,&quot;_skin&quot;:&quot;post&quot;,&quot;columns&quot;:&quot;3&quot;,&quot;columns_mobile&quot;:&quot;1&quot;,&quot;edit_handle_selector&quot;:&quot;[data-elementor-type=\\&quot;loop-item\\&quot;]&quot;,&quot;row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"loop-grid.post\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-loop-container elementor-grid\">\n\t\t<style id=\"loop-2842\">.elementor-2842 .elementor-element.elementor-element-adf3d07{--display:flex;--justify-content:space-between;--gap:20px 20px;--row-gap:20px;--column-gap:20px;border-style:solid;--border-style:solid;border-width:1px 1px 1px 1px;--border-top-width:1px;--border-right-width:1px;--border-bottom-width:1px;--border-left-width:1px;border-color:#44444444;--border-color:#44444444;--border-radius:20px 20px 20px 20px;--margin-top:0px;--margin-bottom:0px;--margin-left:0px;--margin-right:0px;--padding-top:20px;--padding-bottom:30px;--padding-left:20px;--padding-right:20px;--e-con-transform-origin-x:center;--e-con-transform-origin-y:center;}.elementor-2842 .elementor-element.elementor-element-adf3d07:hover{border-style:solid;border-width:1px 1px 1px 1px;--border-top-width:1px;--border-right-width:1px;--border-bottom-width:1px;--border-left-width:1px;border-color:var( --e-global-color-accent );--border-color:var( --e-global-color-accent );}.elementor-2842 .elementor-element.elementor-element-adf3d07, .elementor-2842 .elementor-element.elementor-element-adf3d07::before{--border-transition:0.3s;}.elementor-2842 .elementor-element.elementor-element-adf3d07.e-con:hover{--e-con-transform-scale:1.03;}.elementor-widget-theme-post-title .elementor-heading-title{font-family:var( --e-global-typography-primary-font-family ), Sans-serif;font-size:var( --e-global-typography-primary-font-size );font-weight:var( --e-global-typography-primary-font-weight );color:var( --e-global-color-primary );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-family:var( --e-global-typography-0dec4fd-font-family ), Sans-serif;font-size:var( --e-global-typography-0dec4fd-font-size );font-weight:var( --e-global-typography-0dec4fd-font-weight );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 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--e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}@media(min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:1024px) and (min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:767px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--min-height:0px;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}\/* Start custom CSS for container, class: .elementor-element-adf3d07 *\/.elementor-2842 .elementor-element.elementor-element-adf3d07{\n    position: relative;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .icon-more-posts{\n    position: absolute;\n    bottom: 20px;\n    left: 0;\n    right: 0;\n    opacity: 0;\n    transform: translateY(8px);\n    transition: opacity 0.3s ease, transform 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .icon-more-posts{\n    opacity: 1;\n    transform: translateY(0);\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .loop-post-excerpt{\n    padding-bottom: 0;\n    transition: padding-bottom 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .loop-post-excerpt{\n    padding-bottom: 70px;\n}\/* End custom CSS *\/<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-16130 post-16130 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\/en\/sap-innovation-meets-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 Meets 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\tHow Are Cloud, SaaS, AI &amp; Frequent Releases Changing Validation?\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-12542 post-12542 post type-post status-publish format-standard has-post-thumbnail hentry category-sap-qualitaetsmanagement tag-qm-mit-sap tag-qm-with-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\/en\/sap-qim-end-of-support-and-replacement\/\">\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 End of Support 2027: Why Companies should act now<\/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 ends in 2027: Learn what risks arise and why an early migration to QM in S\/4HANA is\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-12544 post-12544 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\/en\/gxp-friendly-audit-for-saas-platform\/\">\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 for Ledidi Trials: SaaS Platform for regulated Clinical Trials<\/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\tAs part of an independent GxP Friendly Audit, the SaaS platform Ledidi Trials was comprehensively evaluated by DHC.\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 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Learn more about Annex 22 and the EU AI 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Missing regulatory guidance and the resulting uncertainty can become an obstacle to innovation capability and business success, particularly in economically significant, often mid-sized industries such as pharmaceuticals, biotechnology and medical technology. Against this background, there is <\/span><b><span data-contrast=\"auto\">a need for methodological and technological development<\/span><\/b><span data-contrast=\"auto\"> in the validation of AI systems. <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">The overarching framework for further development is set in particular by <\/span><b><span data-contrast=\"auto\">current European regulations on data processing and artificial intelligence<\/span><\/b><span data-contrast=\"auto\">. These include the <\/span><b><span data-contrast=\"auto\">Data Act<\/span><\/b><span data-contrast=\"auto\"> (June 2023), the <\/span><b><span data-contrast=\"auto\">Data Governance Act (DGA)<\/span><\/b><span data-contrast=\"auto\"> (September 2023) and the <\/span><b><span data-contrast=\"auto\">EU AI Act<\/span><\/b><span data-contrast=\"auto\">, which aims to be the world's first comprehensive regulation of artificial intelligence. Future approaches to AI validation must fit within this legal framework. In parallel, there are international initiatives developing industry-specific regulations for AI, for example from the EMA or the FDA.<\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">However, these have so far focused primarily on the regulatory requirements for the development of AI-based systems. For their <\/span><b><span data-contrast=\"auto\">operation<\/span><\/b><span data-contrast=\"auto\">, and consequently also for the question of <\/span><b><span data-contrast=\"auto\">validation and IT compliance<\/span><\/b><span data-contrast=\"auto\">, no definitive answers exist to date. Open questions include:<\/span><\/p><ul><li><span data-contrast=\"auto\">How does AI influence the inspection practices of regulatory authorities?<\/span><\/li><li><span data-contrast=\"auto\">What adjustments are needed for existing CSV methods?<\/span><\/li><li><span data-contrast=\"auto\">How can the required compliance of AI systems be demonstrated?<\/span><\/li><\/ul><p>These questions highlight the existing gap: there is no reliable regulatory framework that systematically connects CSV and AI validation. Likewise, standardized methods and technological tools for verifiably testing AI systems under current regulations are missing.<\/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":"7a95efa","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":"dccc3c9","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":"4306dab","elType":"widget","settings":{"title":"The upcoming Annex 22:<br> A step toward closing the gap?&nbsp;","_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":"8020aab","elType":"widget","settings":{"editor":"<p><span data-contrast=\"auto\">The draft <\/span><b><span data-contrast=\"auto\">Annex 22 \"Artificial Intelligence\"<\/span><\/b><span data-contrast=\"auto\"> is intended to close precisely this gap in the future. It complements <\/span><b><span data-contrast=\"auto\">Annex 11 \"Computerised Systems\"<\/span><\/b><span data-contrast=\"auto\"> and addresses the validation of AI models in GMP-critical applications. Its scope covers machine learning models that acquire their functionality through training with data, not through hard-coded rules. Annex 22 stipulates that only <\/span><b><span data-contrast=\"auto\">static models<\/span><\/b><span data-contrast=\"auto\">, i.e. models with frozen parameters, may be used in critical GMP applications, since these parameters for the manufacturing processes (CPPs) and the corresponding attributes in quality control (CQAs) are usually defined in the medicinal product's marketing authorization dossier and may not be changed. <\/span><b><span data-contrast=\"auto\">Dynamic or generative models<\/span><\/b><span data-contrast=\"auto\"> that continue to evolve after their release are therefore explicitly excluded in this context. Furthermore, the draft describes requirements for <\/span><b><span data-contrast=\"auto\">test data<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">explainability<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">confidence levels<\/span><\/b><span data-contrast=\"auto\">, <\/span><b><span data-contrast=\"auto\">change control<\/span><\/b><span data-contrast=\"auto\"> and <\/span><b><span data-contrast=\"auto\">human-in-the-loop principles<\/span><\/b><span data-contrast=\"auto\">. The goal is to ensure that AI models are only deployed where their performance, stability and traceability are compatible with GMP requirements. <\/span><span data-ccp-props=\"{}\"> <\/span><\/p><p><span data-contrast=\"auto\">This creates, for the first time, a framework that enables the use of AI in regulated environments without jeopardizing the fundamental principles of patient safety, product quality and data integrity.<\/span><\/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":"16e35b4","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":"3f8ed73","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":"007dd55","elType":"widget","settings":{"title":"Conclusion","_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":"cc5cabe","elType":"widget","settings":{"editor":"<p><span data-contrast=\"auto\">The validation of AI systems stands at the intersection of technological innovation and regulatory responsibility. It is currently one of the most dynamic and at the same time least standardized topics in the life sciences sector. Between classical CSV methods and modern, data-driven systems, there is a gap that requires new methods, new ways of thinking, and new tools.<\/span><\/p><p><span data-contrast=\"auto\">With the EU AI Act, a legal framework is being created for the first time that addresses the use of AI across all sectors. Annex 22 \"Artificial Intelligence\" concretizes this framework for GMP-regulated environments and creates the basis for traceable, risk-based validation of AI models. This sets regulatory guardrails that enable innovation without jeopardizing the fundamental principles of patient safety, product quality, and data integrity.<\/span><\/p><p><span data-contrast=\"auto\">For companies, this means: They should engage with the new requirements early, adapt their validation strategies, and build internal competencies for assessing AI systems. Only those who actively shape this transformation can ensure that artificial intelligence does not become a compliance risk but rather an innovation driver in regulated industries.<\/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\/en\/gxp-compliance\/ai-validation\/\">\u2192 More about AI system validation<\/a><\/span><\/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":"1aac793a","elType":"container","settings":{"flex_gap":{"column":"0","row":"0","isLinked":false,"unit":"px","size":0},"background_background":"classic","padding":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_tablet":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"0","right":"20","bottom":"0","left":"20","isLinked":false},"__globals__":{"background_overlay_color":"globals\/colors?id=aaddc3b","background_color":"globals\/colors?id=9b310c9"},"margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_title":"CTA","margin_tablet":{"unit":"px","top":"80","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"50","right":"0","bottom":"0","left":"0","isLinked":false}},"elements":[{"id":"41223ab3","elType":"container","settings":{"flex_direction":"row","boxed_width":{"unit":"px","size":1280,"sizes":[]},"flex_justify_content":"space-evenly","flex_align_items":"center","background_background":"classic","background_image":{"url":"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2025\/11\/achivements_background.webp","id":14413,"size":"","alt":"","source":"library"},"background_repeat":"no-repeat","margin":{"unit":"px","top":"-50","right":"0","bottom":"0","left":"0","isLinked":false},"padding":{"unit":"px","top":"50","right":"50","bottom":"50","left":"50","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_mobile":{"unit":"px","top":"30","right":"20","bottom":"30","left":"20","isLinked":false},"content_width":"full","width":{"unit":"%","size":100},"padding_tablet":{"unit":"px","top":"40","right":"20","bottom":"40","left":"20","isLinked":false},"_element_width_none":"initial","width_none":{"size":681.6},"_element_width":"initial","flex_gap":{"column":"20","row":"0","isLinked":false,"unit":"px","size":20},"background_position":"center 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of AI Systems","align":"start","_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"10","left":"0","isLinked":false},"_element_width":"inherit","_element_custom_width":{"unit":"%","size":91,"sizes":[]},"__globals__":{"typography_typography":""},"_element_custom_width_tablet":{"unit":"%","size":80,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"_padding_mobile":{"unit":"px","top":"10","right":"0","bottom":"0","left":"0","isLinked":false},"_flex_size":"none","_element_width_none":"initial","_element_custom_width_none":{"size":491.025},"align_mobile":"center","typography_typography":"custom","typography_font_family":"Poppins","typography_font_size":{"unit":"custom","size":"clamp(1.125rem, 0.6389rem + 1.5556vw, 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Artikel","margin_tablet":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"margin_mobile":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"padding_tablet":{"unit":"px","top":"75","right":"20","bottom":"75","left":"20","isLinked":false},"padding_mobile":{"unit":"px","top":"50","right":"20","bottom":"50","left":"20","isLinked":false},"flex_justify_content":"center"},"elements":[{"id":"4fd289b3","elType":"widget","settings":{"title":"Magazine","_margin":{"unit":"px","top":"60","right":"0","bottom":"20","left":"0","isLinked":false},"_padding":{"unit":"px","top":"8","right":"13","bottom":"8","left":"13","isLinked":false},"_flex_align_self":"center","_background_background":"gradient","_background_color_b":"","_border_radius":{"unit":"px","top":"100","right":"100","bottom":"100","left":"100","isLinked":true},"__globals__":{"title_color":"globals\/colors?id=9b310c9","_background_color":"globals\/colors?id=accent","typography_typography":"globals\/typography?id=secondary"},"header_size":"div"},"elements":[],"widgetType":"heading"},{"id":"52106f4c","elType":"widget","settings":{"title":"More Articles from the Blog","align":"center","_margin":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"_padding":{"unit":"px","top":"0","right":"0","bottom":"0","left":"0","isLinked":false},"__globals__":{"typography_typography":"globals\/typography?id=42dac7a"},"_element_custom_width_tablet":{"unit":"%","size":80,"sizes":[]},"_element_custom_width_mobile":{"unit":"%","size":100,"sizes":[]},"_padding_mobile":{"unit":"px","top":"10","right":"0","bottom":"20","left":"0","isLinked":false},"_flex_align_self":"center"},"elements":[],"widgetType":"heading"},{"id":"25940306","elType":"widget","settings":{"template_id":2842,"alternate_templates":[{"template_id":null,"_id":"de51286"}],"pagination_page_limit":"5","pagination_prev_label":"Voriger","pagination_next_label":"N\u00e4chster","text":"Load More","load_more_no_posts_custom_message":"No more posts to show","nothing_found_message_text":"It seems we can\u2019t find what you\u2019re looking 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Learn more about Annex 22 and the EU AI Act.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validation of AI Systems in Regulated Industries\" \/>\n<meta property=\"og:description\" content=\"How can artificial intelligence be validated and brought into regulatory compliance? 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