{"id":8506,"date":"2025-07-23T13:48:39","date_gmt":"2025-07-23T05:48:39","guid":{"rendered":"https:\/\/regask.com\/?p=8506"},"modified":"2025-07-23T13:50:16","modified_gmt":"2025-07-23T05:50:16","slug":"mise-a-jour-de-la-documentation-des-systemes-informatises-dia-des-lignes-directrices-bpf-de-lue-2025","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","title":{"rendered":"La Commission europ\u00e9enne lance une consultation publique sur la mise \u00e0 jour\u2026"},"content":{"rendered":"<p>Sur <strong>7 juillet 2025<\/strong>, le <a href=\"https:\/\/commission.europa.eu\/about\/departments-and-executive-agencies\/health-and-food-safety_en\"><strong>Direction g\u00e9n\u00e9rale de la sant\u00e9 et de la s\u00e9curit\u00e9 alimentaire de la Commission europ\u00e9enne<\/strong><\/a> a ouvert un <strong>consultation publique<\/strong> sur les r\u00e9visions propos\u00e9es \u00e0 <strong>EudraLex Volume 4 \u2013 Lignes directrices sur les bonnes pratiques de fabrication (BPF)<\/strong>Les mises \u00e0 jour s&#039;appliquent \u00e0 :<\/p>\n<ul>\n<li><strong>Chapitre 4 : Documentation<\/strong><\/li>\n<li><strong>Annexe 11 : Syst\u00e8mes informatis\u00e9s<\/strong><\/li>\n<li><strong>Annexe 22 : Intelligence artificielle<\/strong> <em>(nouvellement introduit)<\/em><\/li>\n<\/ul>\n<p>Ces changements propos\u00e9s visent \u00e0 <strong>moderniser les pratiques GMP<\/strong> en renfor\u00e7ant <strong>int\u00e9grit\u00e9 des donn\u00e9es<\/strong>, int\u00e9grant <strong>Gouvernance de l&#039;IA<\/strong>et am\u00e9liorer la surveillance de <strong>syst\u00e8mes informatis\u00e9s<\/strong> et <strong>documentation<\/strong> dans <strong>fabrication pharmaceutique<\/strong>.<\/p>\n<p><strong>Points cl\u00e9s :<\/strong><\/p>\n<ul>\n<li>Le <strong>Chapitre 4 mis \u00e0 jour<\/strong> souligne <strong>pratiques de documentation fond\u00e9es sur les risques<\/strong>, ainsi qu&#039;une gestion am\u00e9lior\u00e9e de <strong>dossiers \u00e9lectroniques<\/strong> et <strong>signatures<\/strong>, tout en assurant la <strong>lisibilit\u00e9 et int\u00e9grit\u00e9<\/strong> de la documentation dans tous les formats.<\/li>\n<li>Le <strong>Annexe 11 r\u00e9vis\u00e9e<\/strong> renforce l&#039;application de <strong>Gestion des risques qualit\u00e9 (QRM)<\/strong> tout au long du cycle de vie de <strong>syst\u00e8mes informatis\u00e9s<\/strong>, en introduisant des contr\u00f4les plus stricts pour <strong>proc\u00e8s d&#039;audit<\/strong>, <strong>s\u00e9curit\u00e9 du syst\u00e8me<\/strong>, et <strong>surveillance des fournisseurs<\/strong>.<\/li>\n<li>Le <strong>nouvelle annexe 22<\/strong> \u00e9tablit un cadre r\u00e9glementaire clair pour l&#039;utilisation des <strong>L&#039;intelligence artificielle dans les environnements GMP<\/strong>, r\u00e9pondant aux exigences li\u00e9es \u00e0 <strong>validation du mod\u00e8le<\/strong>, <strong>qualit\u00e9 des donn\u00e9es de formation<\/strong>, <strong>indicateurs de performance<\/strong>, et <strong>surveillance humaine continue<\/strong>.<\/li>\n<\/ul>\n<h4><strong>Date limite de retour\u00a0: 7\u00a0octobre\u00a02025<\/strong><\/h4>\n\t<div id=\"gap-459520359\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-459520359 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p><strong>Pourquoi c&#039;est important :<\/strong><br \/>Ces r\u00e9visions devraient :<\/p>\n<ul>\n<li>Am\u00e9liorer <strong>clart\u00e9 r\u00e9glementaire<\/strong><\/li>\n<li>Aligner avec <strong>technologies num\u00e9riques \u00e9mergentes<\/strong><\/li>\n<li>Promouvoir <strong>efficacit\u00e9 op\u00e9rationnelle<\/strong><\/li>\n<li>Introduire <strong>nouvelles charges de conformit\u00e9 minimales<\/strong><\/li>\n<\/ul>\n<p><strong>La contribution des parties prenantes jouera un r\u00f4le essentiel dans l\u2019\u00e9laboration de directives pratiques et align\u00e9es sur les avanc\u00e9es technologiques.<\/strong> Ces mises \u00e0 jour sont particuli\u00e8rement pertinentes pour les professionnels <strong>Qualit\u00e9, affaires r\u00e9glementaires, conformit\u00e9 informatique et d\u00e9ploiement de l&#039;IA dans les BPF-<\/strong>environnements r\u00e9glement\u00e9s.<\/p>\n<p><strong>Prochaines \u00e9tapes<\/strong><br \/>Les parties prenantes doivent examiner les projets de r\u00e9vision du chapitre 4, de l&#039;annexe 11 et de l&#039;annexe 22, \u00e9valuer leur impact interne et coordonner les retours interfonctionnels. Les commentaires doivent \u00eatre soumis via le <a href=\"https:\/\/health.ec.europa.eu\/consultations\/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en\">Portail de la Commission europ\u00e9enne par <strong>7 octobre 2025<\/strong>.<\/a><\/p>\n<p><strong>Comment RegASK aide<\/strong><br \/>RegASK est une plateforme bas\u00e9e sur l&#039;IA qui surveille en permanence les mises \u00e0 jour r\u00e9glementaires, y compris les directives GMP et IA, pour aider les \u00e9quipes des sciences de la vie \u00e0 rester conformes et pr\u00e9par\u00e9es.<br \/><a href=\"https:\/\/regask.com\/fr\/\"><strong>En savoir plus<\/strong><\/a><strong> ou <\/strong><a href=\"https:\/\/regask.com\/fr\/reserver-une-demo\/\"><strong>r\u00e9server une d\u00e9mo<\/strong><\/a><\/p>\n<div class=\"is-divider divider clearfix\" style=\"margin-top:1em;margin-bottom:1em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n\t<div id=\"gap-1659703326\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1659703326 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4><strong>FAQ<\/strong><\/h4>\n\t<div id=\"gap-2077862166\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2077862166 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<ol>\n<li><strong> Qu&#039;est-ce que l&#039;annexe 22 des lignes directrices GMP de l&#039;UE mises \u00e0 jour ?<\/strong><br \/>\nL&#039;annexe 22 est une nouvelle section propos\u00e9e dans le cadre du volume 4 d&#039;EudraLex. Elle d\u00e9finit les exigences r\u00e9glementaires relatives \u00e0 l&#039;utilisation de l&#039;intelligence artificielle dans la fabrication pharmaceutique, y compris la validation des mod\u00e8les, les normes de donn\u00e9es de formation et la surveillance humaine.<\/li>\n<li><strong> Quels changements sont apport\u00e9s aux syst\u00e8mes informatis\u00e9s en vertu de l\u2019annexe 11 ?<\/strong><br \/>\nL&#039;annexe 11 mise \u00e0 jour introduit des pratiques plus strictes de gestion des risques qualit\u00e9 pour les syst\u00e8mes informatis\u00e9s. Elle met l&#039;accent sur les essais d&#039;audit, les signatures \u00e9lectroniques, la s\u00e9curit\u00e9 des syst\u00e8mes et la surveillance des fournisseurs.<\/li>\n<li><strong> Quelles sont les exigences de documentation dans le chapitre 4 r\u00e9vis\u00e9 des BPF de l\u2019UE ?<\/strong><br \/>\nLe chapitre 4 r\u00e9vis\u00e9 met l&#039;accent sur l&#039;int\u00e9grit\u00e9 des donn\u00e9es, la gouvernance ax\u00e9e sur les risques et la gestion appropri\u00e9e de la documentation sous tous ses formats. Il renforce \u00e9galement les exigences en mati\u00e8re de gestion des enregistrements et des signatures \u00e9lectroniques.<\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>On July 7, 2025, the European Commission\u2019s Directorate-General for Health and Food Safety opened a public consultation on proposed revisions to EudraLex Volume 4 \u2013 Good Manufacturing Practice (GMP) Guidelines. The updates apply to: Chapter 4: Documentation Annex 11: Computerized Systems Annex 22: Artificial Intelligence (newly introduced) These proposed changes aim to modernize GMP practices&#8230;<\/p>","protected":false},"author":32,"featured_media":8508,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[529,33],"tags":[],"class_list":["post-8506","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>European Commission Launches GMP Consultation | RegASK<\/title>\n<meta name=\"description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. Discover key changes in Chapter 4, Annex 11, and the new Annex 22 before the October 7, 2025 deadline.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/fr\/mise-a-jour-de-la-documentation-des-systemes-informatises-dia-des-lignes-directrices-bpf-de-lue-2025\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Launches Public Consultation on Updated GMP Guidelines for AI, Computerized Systems, and Documentation\" \/>\n<meta property=\"og:description\" content=\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. Discover key changes in Chapter 4, Annex 11, and the new Annex 22 before the October 7, 2025 deadline.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/fr\/mise-a-jour-de-la-documentation-des-systemes-informatises-dia-des-lignes-directrices-bpf-de-lue-2025\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-07-23T05:48:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-23T05:50:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/07\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Hannah Nordin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Hannah Nordin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/\"},\"author\":{\"name\":\"Hannah Nordin\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\"},\"headline\":\"European Commission Launches Public Consultation on Upd&hellip;\",\"datePublished\":\"2025-07-23T05:48:39+00:00\",\"dateModified\":\"2025-07-23T05:50:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/\"},\"wordCount\":430,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png\",\"articleSection\":[\"Europe &amp; Central Asia\",\"Regulatory News\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/\",\"name\":\"European Commission Launches GMP Consultation | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png\",\"datePublished\":\"2025-07-23T05:48:39+00:00\",\"dateModified\":\"2025-07-23T05:50:16+00:00\",\"description\":\"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. Discover key changes in Chapter 4, Annex 11, and the new Annex 22 before the October 7, 2025 deadline.\",\"inLanguage\":\"fr-FR\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/07\\\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png\",\"width\":800,\"height\":600,\"caption\":\"Regulatory Update European Commission Launches Gmp Consultation Ai Computerized Systems Documentation\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"Empowering Smarter Regulatory Decisions\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"fr-FR\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\",\"name\":\"RegASK\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"fr-FR\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/RegASK-Logo-Dark-Round.png\",\"width\":401,\"height\":401,\"caption\":\"RegASK\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/RegASKRegulatoryAffairs\\\/\",\"https:\\\/\\\/x.com\\\/ASKRegASK\",\"https:\\\/\\\/www.linkedin.com\\\/company\\\/RegASK\\\/\",\"https:\\\/\\\/www.youtube.com\\\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/3a8aaee2c7585284f97ec9e038e36b65\",\"name\":\"Hannah Nordin\",\"sameAs\":[\"https:\\\/\\\/regask.com\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"La Commission europ\u00e9enne lance une consultation sur les BPF | RegASK","description":"L&#039;UE lance une consultation publique sur les mises \u00e0 jour des BPF concernant l&#039;IA, les syst\u00e8mes informatis\u00e9s et la documentation. D\u00e9couvrez les principaux changements du chapitre 4, de l&#039;annexe 11 et de la nouvelle annexe 22 avant la date limite du 7 octobre 2025.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/fr\/mise-a-jour-de-la-documentation-des-systemes-informatises-dia-des-lignes-directrices-bpf-de-lue-2025\/","og_locale":"fr_FR","og_type":"article","og_title":"European Commission Launches Public Consultation on Updated GMP Guidelines for AI, Computerized Systems, and Documentation","og_description":"The EU launches a public consultation on GMP updates covering AI, computerized systems, and documentation. Discover key changes in Chapter 4, Annex 11, and the new Annex 22 before the October 7, 2025 deadline.","og_url":"https:\/\/regask.com\/fr\/mise-a-jour-de-la-documentation-des-systemes-informatises-dia-des-lignes-directrices-bpf-de-lue-2025\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2025-07-23T05:48:39+00:00","article_modified_time":"2025-07-23T05:50:16+00:00","og_image":[{"width":800,"height":600,"url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/07\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png","type":"image\/png"}],"author":"Hannah Nordin","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Hannah Nordin","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/#article","isPartOf":{"@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/"},"author":{"name":"Hannah Nordin","@id":"https:\/\/regask.com\/#\/schema\/person\/3a8aaee2c7585284f97ec9e038e36b65"},"headline":"European Commission Launches Public Consultation on Upd&hellip;","datePublished":"2025-07-23T05:48:39+00:00","dateModified":"2025-07-23T05:50:16+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/"},"wordCount":430,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/07\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png","articleSection":["Europe &amp; Central Asia","Regulatory News"],"inLanguage":"fr-FR"},{"@type":"WebPage","@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","url":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/","name":"La Commission europ\u00e9enne lance une consultation sur les BPF | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/07\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png","datePublished":"2025-07-23T05:48:39+00:00","dateModified":"2025-07-23T05:50:16+00:00","description":"L&#039;UE lance une consultation publique sur les mises \u00e0 jour des BPF concernant l&#039;IA, les syst\u00e8mes informatis\u00e9s et la documentation. D\u00e9couvrez les principaux changements du chapitre 4, de l&#039;annexe 11 et de la nouvelle annexe 22 avant la date limite du 7 octobre 2025.","inLanguage":"fr-FR","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/"]}]},{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/eu-gmp-guidelines-2025-ai-computerized-systems-documentation-update\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2025\/07\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2025\/07\/regulatory-update-european-commission-launches-gmp-consultation-ai-computerized-systems-documentation.png","width":800,"height":600,"caption":"Regulatory Update European Commission Launches Gmp Consultation Ai Computerized Systems Documentation"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"Favoriser des d\u00e9cisions r\u00e9glementaires plus intelligentes","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"fr-FR"},{"@type":"Organization","@id":"https:\/\/regask.com\/#organization","name":"RegASK","url":"https:\/\/regask.com\/","logo":{"@type":"ImageObject","inLanguage":"fr-FR","@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/","url":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2024\/10\/RegASK-Logo-Dark-Round.png","width":401,"height":401,"caption":"RegASK"},"image":{"@id":"https:\/\/regask.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","https:\/\/x.com\/ASKRegASK","https:\/\/www.linkedin.com\/company\/RegASK\/","https:\/\/www.youtube.com\/playlist?list=PL6yPC6gFqelkHbOeyUVKjtHOZXZ2LQbJd"]},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/3a8aaee2c7585284f97ec9e038e36b65","name":"Hannah Nordin","sameAs":["https:\/\/regask.com"]}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/8506","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/users\/32"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/comments?post=8506"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/posts\/8506\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media\/8508"}],"wp:attachment":[{"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/media?parent=8506"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/categories?post=8506"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/fr\/wp-json\/wp\/v2\/tags?post=8506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}