{"id":6215,"date":"2022-11-28T12:50:42","date_gmt":"2022-11-28T11:50:42","guid":{"rendered":"https:\/\/staging.thescon.de\/?p=6215"},"modified":"2024-02-27T18:11:48","modified_gmt":"2024-02-27T17:11:48","slug":"ema-concept-paper-on-the-revision-of-annex-11","status":"publish","type":"post","link":"https:\/\/www.thescon.de\/en\/ema-concept-paper-on-the-revision-of-annex-11\/","title":{"rendered":"EMA: Concept Paper on the revision of Annex 11 about computerized systems"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6215\" class=\"elementor elementor-6215\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2d9a0e19 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"2d9a0e19\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7df060cb\" data-id=\"7df060cb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c372e37 elementor-widget elementor-widget-text-editor\" data-id=\"c372e37\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div id=\"column_vtfQF\" class=\"hc_column_cnt col-md-12 \"><div class=\"row\"><div class=\"col-md-12 hc_title_tag_cnt\"><h3 id=\"5ZtkF\" class=\" \">EMA: Concept Paper on the revision of Annex 11 about computerized systems<\/h3><\/div><div class=\"col-md-12 hc_title_tag_cnt\"><p id=\"ONGw3\" class=\" text-light \"><strong>On November 16, 2022, the EMA (European Medicines Agency) published a 5-page concept paper on the revision of Annex 11<\/strong><\/p><\/div><div class=\"col-md-12 hc_space_cnt\">\u00a0<\/div><\/div><\/div><div id=\"column_ukbGZ\" class=\"hc_column_cnt col-md-6 \"><div class=\"row\"><div class=\"col-md-12 hc_wp_editor_cnt\"><div id=\"qlqa7\" class=\"main-text wysiwyg-editor \"><p>The Annex 11 of the EU GMP Guideline is 11 years old. The EMA has now published a concept paper on how it intends to revise Annex 11 and allows comments until January 16th, 2023.<\/p><p>This places new compliance requirements on your regulated company! The concept paper explicitly mentions that the adaptation of existing systems to new requirements will be associated with costs.<\/p><p>Together with the PIC\/S, the EMA proposes the following innovations and changes, among others:<\/p><ul><li>The contents of the new Annex 11 are to replace the Q&amp;A on Annex 11 and the Q&amp;A on data integrity<\/li><li>Requirements regarding &#8216;data in motion&#8217; and &#8216;data at rest&#8217; are to be include<\/li><li>Modern concepts for &#8216;digital transformation&#8217; should be taken into account<\/li><li>Criteria for the use of agile project methods will be defined<\/li><li>The EMA sees an urgent need to regulate machine learning and artificial intelligence in the context of GMP applications<\/li><li>Requirements for audit trails to become more comprehensive and detailed<\/li><li>Contents from the FDA Guidance on CSA are to be taken into account<\/li><\/ul><p>Thescon will follow the further development for you and keep you informed.<\/p><p>The EMA concept paper can be found here (PDF link):<\/p><p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products_en.pdf\">https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products_en.pdf<\/a><\/p><\/div><\/div><\/div><\/div>\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>EMA and PIC\/s outline new compliance requirements for companies: What&#8217;s in store?<\/p>\n","protected":false},"author":11,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-6215","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts\/6215","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/comments?post=6215"}],"version-history":[{"count":19,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts\/6215\/revisions"}],"predecessor-version":[{"id":6579,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/posts\/6215\/revisions\/6579"}],"wp:attachment":[{"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/media?parent=6215"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/categories?post=6215"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thescon.de\/en\/wp-json\/wp\/v2\/tags?post=6215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}