{"id":12582,"date":"2025-07-22T16:13:01","date_gmt":"2025-07-22T14:13:01","guid":{"rendered":"https:\/\/dhc.ima.vc\/drafts-veroeffentlicht-annex-11-annex-22\/"},"modified":"2026-05-07T16:18:55","modified_gmt":"2026-05-07T14:18:55","slug":"drafts-published-annex-11-annex-22","status":"publish","type":"post","link":"https:\/\/dhc.ima.vc\/en\/drafts-published-annex-11-annex-22\/","title":{"rendered":"Drafts Published: Annex 11 &amp; New Annex 22"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12582\" class=\"elementor elementor-12582 elementor-8744\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f897850 e-con-full e-flex e-con e-parent\" data-id=\"f897850\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-ae80faa e-flex e-con-boxed e-con e-child\" data-id=\"ae80faa\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-21d8f3a e-con-full e-flex e-con e-child\" data-id=\"21d8f3a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-11a4c88 e-flex e-con-boxed e-con e-parent\" data-id=\"11a4c88\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-768d3d0f e-con-full e-flex e-con e-child\" data-id=\"768d3d0f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-4e87f91d e-con-full e-flex e-con e-child\" data-id=\"4e87f91d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4fe2c71f elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"4fe2c71f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Drafts Published: Annex 11 &amp; New Annex 22<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-617c4168 elementor-widget elementor-widget-text-editor\" data-id=\"617c4168\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-testid=\"markdown-response\"><p id=\"message\">On July 7, 2025, the European Commission, together with PIC\/S, published the long-awaited drafts for the revision of Annex 11 &#8220;Computerised Systems&#8221; and the entirely new Annex 22 &#8220;Artificial Intelligence.&#8221; In parallel, Chapter 4 &#8220;Documentation&#8221; of the EU GMP Guide was also revised. <\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39f1ce66 elementor-author-box--align-left elementor-author-box--layout-image-left elementor-widget elementor-widget-author-box\" data-id=\"39f1ce66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/03\/karsten-schulz-dhc-experte-300x300.webp\" alt=\"Picture of  Karsten Schulz, Director Sales, Marketing &amp; Business Development, DHC GmbH\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\t\t\t\t\t<div >\n\t\t\t\t\t\t<div class=\"elementor-author-box__name\">\n\t\t\t\t\t\t\t Karsten Schulz, Director Sales, Marketing & Business Development, DHC GmbH\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3a5a2caa e-con-full e-flex e-con e-child\" data-id=\"3a5a2caa\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5b9d90af elementor-widget elementor-widget-theme-post-featured-image elementor-widget-image\" data-id=\"5b9d90af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"theme-post-featured-image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"350\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11.webp\" class=\"attachment-full size-full wp-image-13523\" alt=\"\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11.webp 1200w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11-300x88.webp 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11-1024x299.webp 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex11-768x224.webp 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-52e93d4 e-flex e-con-boxed e-con e-parent\" data-id=\"52e93d4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-2f87555 e-con-full e-flex e-con e-child\" data-id=\"2f87555\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7d5a3e65 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"7d5a3e65\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>These guidelines are central components of the GMP regulatory framework for computerized systems and AI applications in regulated industries such as pharma, biotechnology, and medical technology. They define requirements for the integrity, validation, and control of IT systems that support GMP-relevant processes. <\/p><p>Corresponding documents for the GLP and GCP sectors have already been published in recent years. The drafts mark a decisive step toward a modern, risk-based approach to digital technologies in the GMP environment, but also place high demands on the operator (regulated user).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bae2567 e-flex e-con-boxed e-con e-parent\" data-id=\"bae2567\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-cf45cfc e-con-full e-flex e-con e-child\" data-id=\"cf45cfc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3856547 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"3856547\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What's new in Annex 11 and Annex 22?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb14fa7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"bb14fa7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>The revised content of Annex 11 brings clarity, precision and updates in many areas, particularly with regard to:<\/strong><\/p><ul class=\"check-list\"><li>Lifecycle management of computerized systems<img decoding=\"async\" class=\"alignright wp-image-11900\" src=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik.jpg\" alt=\"\" width=\"400\" height=\"400\" srcset=\"https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik.jpg 1254w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-300x300.jpg 300w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-1024x1024.jpg 1024w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-150x150.jpg 150w, https:\/\/dhc.ima.vc\/wp-content\/uploads\/2026\/04\/annex_11_grafik-768x768.jpg 768w\" sizes=\"(max-width: 400px) 100vw, 400px\" \/><\/li><li>Data integrity and audit trails<\/li><li>Cloud and SaaS usage<\/li><li>Supplier management and role allocation<\/li><li>IT security<\/li><\/ul><p>At the same time, however, certain provisions that were included in the earlier version (from 2011) are also missing.<\/p><p><strong>The new Annex 22 takes artificial intelligence (AI) and machine learning (ML) explicitly into the regulatory focus for the first time. It addresses, among other things:<\/strong><\/p><ul class=\"check-list\"><li>Validation requirements for AI\/ML models<\/li><li>Transparency, explainability and bias control<\/li><li>Responsibilities for training, deployment and monitoring<\/li><li>Risk-based assessment of algorithmic decisions<\/li><\/ul><p>The document represents a good initial approach to regulation that will certainly need to be revised frequently to keep pace with the rapid changes in technology. This makes it clear: the authorities are creating a defined framework to bring innovation and regulation into balance, while complexity and responsibility for GxP managers continue to grow.<\/p><p>In the revised Chapter 4 (Documentation) of the EU GMP Guide, several important elements for IT systems in manufacturing and control are being reconsidered (e.g. hybrid documentation, raw data, electronic signatures). This means that certain regulations within companies will also need to be adapted.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-df2e4a2 e-flex e-con-boxed e-con e-parent\" data-id=\"df2e4a2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-da8fa93 e-con-full e-flex e-con e-child\" data-id=\"da8fa93\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9a4e66b elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"9a4e66b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What does this mean for compliance officers?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0358518 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"0358518\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>The drafts require concrete actions from companies that use GxP-relevant IT systems or AI-based functions, whether in quality assurance, manufacturing, or logistics. Those responsible for compliance, IT, quality, and validation should now:<\/p><ul class=\"check-list\"><li>Analyze the drafts and assess which systems, technologies, and processes are affected<\/li><li>Conduct risk-based gap analyses against the new requirements<\/li><li>Revise validation and QM documentation, e.g., regarding roles, system responsibility, cloud usage, or IT security.<\/li><li>Reassess AI projects with GxP relevance: Has the model used been reviewed according to the requirements? Is the model explainable? Is &#8220;AI Lifecycle Management&#8221; in place?<\/li><\/ul><p style=\"text-align: left;\"><strong>Important: Even existing systems that are already validated must be reviewed in the context of the new requirements, especially if new technologies, automation, or external services (service providers) are involved.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2f8c86d e-flex e-con-boxed e-con e-parent\" data-id=\"2f8c86d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-bca14a4 e-con-full e-flex e-con e-child\" data-id=\"bca14a4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f4bd872 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"f4bd872\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How can DHC support you in meeting the regulatory requirements of Annex 11 and 22?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a5ff9e elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"4a5ff9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>As a specialist in SAP solutions for the life sciences environment and with nearly 30 years of experience in GxP compliance and validation, we support companies specifically in the following areas:<\/p><ul class=\"check-list\"><li>Gap analysis &amp; impact assessment<\/li><li>Structured evaluation of the new Annex 11, Annex 22, and Chapter 4 requirements on your IT and QM landscape<\/li><li>Prioritization of action areas based on risk and relevance<\/li><li>Validation strategy &amp; documentation<\/li><li>Revision of validation concepts, SOPs, RACI matrices, and test strategies<\/li><li>Establishment of traceable lifecycle management for AI-supported systems<\/li><li>AI compliance &amp; AI readiness<\/li><li>Support in the regulatory assessment of AI\/ML systems<\/li><li>Definition and implementation of control mechanisms (e.g., model monitoring, bias detection, explainability)<\/li><li>Tool-supported implementation with SAP<\/li><li>Consulting on integrating validation into SAP processes (e.g., via SAP Cloud ALM)<\/li><li>Use of the DHC Smart Validation Accelerator for cost-effective automation and documentation of validation processes in the SAP environment<\/li><li>Guidance within the SAP End-to-End Digital Validation Platform (E2E DVP)<\/li><\/ul><p style=\"text-align: left;\"> <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1aac793a e-flex e-con-boxed e-con e-child\" data-id=\"1aac793a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-41223ab3 e-con-full e-flex e-con e-child\" data-id=\"41223ab3\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-1117cb89 e-con-full e-flex e-con e-child\" data-id=\"1117cb89\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7571e62 elementor-widget__width-inherit elementor-widget elementor-widget-heading\" data-id=\"7571e62\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Drafts for AI &amp; ML Published: Annex 11 &amp; New Annex 22 <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1fc7341d elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"1fc7341d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div data-testid=\"markdown-response\"><p id=\"message\">Receive an initial assessment of the impacts and concrete starting points for gap analysis, validation strategy, and AI compliance.<\/p><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b9cfc72 elementor-mobile-align-center custom-button elementor-widget elementor-widget-button\" data-id=\"4b9cfc72\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/dhc.ima.vc\/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( 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);margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}.elementor-widget-icon.elementor-view-stacked .elementor-icon{background-color:var( --e-global-color-primary );}.elementor-widget-icon.elementor-view-framed .elementor-icon, .elementor-widget-icon.elementor-view-default .elementor-icon{color:var( --e-global-color-primary );border-color:var( --e-global-color-primary );}.elementor-widget-icon.elementor-view-framed .elementor-icon, .elementor-widget-icon.elementor-view-default .elementor-icon svg{fill:var( --e-global-color-primary );}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon-wrapper{text-align:center;}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon{font-size:54px;}.elementor-2842 .elementor-element.elementor-element-2511066 .elementor-icon svg{height:54px;}.elementor-2842 .elementor-element.elementor-element-2511066{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;padding:0px 0px 0px 0px;}@media(max-width:1024px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--justify-content:space-evenly;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-2842 .elementor-element.elementor-element-dc3b08a{margin:0px 0px calc(var(--kit-widget-spacing, 0px) + 0px) 0px;}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}@media(min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:1024px) and (min-width:768px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--width:100%;}}@media(max-width:767px){.elementor-2842 .elementor-element.elementor-element-adf3d07{--min-height:0px;}.elementor-widget-theme-post-title .elementor-heading-title{font-size:var( --e-global-typography-primary-font-size );}.elementor-2842 .elementor-element.elementor-element-dc3b08a .elementor-heading-title{font-size:var( --e-global-typography-0dec4fd-font-size );line-height:var( --e-global-typography-0dec4fd-line-height );letter-spacing:var( --e-global-typography-0dec4fd-letter-spacing );word-spacing:var( --e-global-typography-0dec4fd-word-spacing );}.elementor-widget-theme-post-excerpt{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}.elementor-2842 .elementor-element.elementor-element-8da389e{font-size:var( --e-global-typography-text-font-size );line-height:var( --e-global-typography-text-line-height );}}\/* Start custom CSS for container, class: .elementor-element-adf3d07 *\/.elementor-2842 .elementor-element.elementor-element-adf3d07{\n    position: relative;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .icon-more-posts{\n    position: absolute;\n    bottom: 20px;\n    left: 0;\n    right: 0;\n    opacity: 0;\n    transform: translateY(8px);\n    transition: opacity 0.3s ease, transform 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .icon-more-posts{\n    opacity: 1;\n    transform: translateY(0);\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07 .loop-post-excerpt{\n    padding-bottom: 0;\n    transition: padding-bottom 0.3s ease;\n}\n\n.elementor-2842 .elementor-element.elementor-element-adf3d07:hover .loop-post-excerpt{\n    padding-bottom: 70px;\n}\/* End custom CSS *\/<\/style>\t\t<div data-elementor-type=\"loop-item\" data-elementor-id=\"2842\" class=\"elementor elementor-2842 e-loop-item e-loop-item-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 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>What companies need to know and do now.<\/p>\n","protected":false},"author":4,"featured_media":13523,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[98],"tags":[121,139],"class_list":["post-12582","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gxp-compliance-csv","tag-annex-11","tag-annex-22"],"acf":[],"yoast_title":"%%sitename%% %%title%% %%primary_category%%","yoast_metadesc":"The drafts of Annexes 11 and 22 and the future of GxP compliance\u2014what companies need to know and do 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