{"id":13256,"date":"2024-08-01T17:44:45","date_gmt":"2024-08-01T15:44:45","guid":{"rendered":"https:\/\/q-finity.de\/?p=13256"},"modified":"2024-11-11T18:48:45","modified_gmt":"2024-11-11T17:48:45","slug":"publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data","status":"publish","type":"post","link":"https:\/\/q-finity.de\/en\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\/","title":{"rendered":"Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data"},"content":{"rendered":"<p><a href=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png\"><img data-opt-id=1417561457  fetchpriority=\"high\" decoding=\"async\" class=\"alignright wp-image-13251\" title=\"Good practice guide\" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:285\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png\" alt=\"Good practice guide\" width=\"357\" height=\"339\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:285\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:730\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:670\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 705w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:844\/h:802\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2024\/08\/Bildschirmfoto-2024-08-01-um-16.41.06.png 844w\" sizes=\"(max-width: 357px) 100vw, 357px\"><\/a>The ISPE has just published the second edition of the GAMP Good Practice Guide (GPG): Validation and Compliance of Computerized GCP Systems and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a>. <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> employees were part of the team that worked on this edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> currently available.<\/p>\n<p>The first edition was published in 2017. This update was necessary as significant advances have been made in the conduct of clinical trials in recent years. Some of these changes, such as decentralized clinical trials, have been accelerated by the COVID-19 pandemic. The changes in the industry have also prompted regulators to issue guidance such as the EMA&rsquo;s &ldquo;Guideline on computerized systems and electronic <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> in clinical trials&rdquo; and the &ldquo;Notice to sponsors on the validation and qualification of computerized systems for clinical trials&rdquo;, which have been taken into account when updating the guide. The content was also significantly expanded to include information on real world <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> \/ real world evidence, <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> protection in clinical trials, artificial intelligence and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a> science, and decentralized clinical trials. Last but not least, the guide had to be adapted to the 2nd edition of GAMP 5.<\/p>\n<p>More information about the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and <a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">Data<\/a> can be found <a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-computerized-gcp-systems-data-2nd-edition\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The ISPE has just published the second edition of the GAMP Good Practice Guide (GPG): Validation and Compliance of Computerized GCP Systems and Data. QFINITY employees were part of the team that worked on this edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and data currently [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-13256","post","type-post","status-publish","format-standard","hentry","category-news-category"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GAMP GPG: Computer GCP Systems &amp; Data 2nd Ed<\/title>\n<meta name=\"description\" content=\"QFINITY employees were part of the team that worked on the GAMP Good Practice Guide: Computer GCP Systems &amp; Data 2nd Edition.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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