{"id":13256,"date":"2024-08-01T17:44:45","date_gmt":"2024-08-01T15:44:45","guid":{"rendered":"https:\/\/q-finity.de\/?p=13256"},"modified":"2026-07-19T09:00:16","modified_gmt":"2026-07-19T07:00:16","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>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.\" class=\"encyclopedia\">Data<\/a>. 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 available.<\/p>\n<p>The first edition was published in 2017. This update was necessary because the conduct of clinical trials has seen significant advances in recent years. The COVID-19 pandemic accelerated some of these changes, such as decentralized clinical trials. Industry changes have also prompted regulators to issue guidance such as the EMA&rsquo;s &ldquo;Guideline on computerized systems and electronic data in clinical trials&rdquo; and the &ldquo;Notice to sponsors on the validation and qualification of computerized systems for clinical trials&rdquo;, both of which the update takes into account. The new edition also adds content on real world data \/ real world evidence, data protection in clinical trials, artificial intelligence and data science, and decentralized clinical trials. Last but not least, the guide has been aligned with <a href=\"https:\/\/q-finity.de\/en\/glossar\/gamp-5-begriff\/\" target=\"_self\" title=\"GAMP 5 - &quot;A Risk-Based Approach to Compliant GxP Computerized Systems&quot; - is ISPE's industry guide to the validation of computerized systems: published in 2008, and available since 2022 in the Second Edition, which strengthens critical thinking and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements - GAMP shows a&hellip;\" class=\"encyclopedia\">GAMP 5<\/a> Second Edition.<\/p>\n<p>You can find more information about the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data <a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-computerized-gcp-systems-data-2nd-edition\">here<\/a>.<br>\n<a class=\"qf-extref\" href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-good-practice-guide-computerized-gcp-systems-data-2nd-edition\" target=\"_blank\" rel=\"noopener\"><span class=\"qf-extref-text\">View the Good Practice Guide at ISPE (ispe.org)<\/span><span class=\"qf-extref-arrow\">&#8599;<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 available. [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":13250,"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","has-post-thumbnail","hentry","category-news-category"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GAMP Good Practice Guide GCP 2nd Edition | QFINITY<\/title>\n<meta name=\"description\" content=\"ISPE publishes the 2nd edition of its GAMP Good Practice Guide on computerized GCP systems &amp; data - greatly expanded, with QFINITY on the author team.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GAMP Good Practice Guide GCP 2nd Edition | QFINITY\" \/>\n<meta property=\"og:description\" content=\"ISPE publishes the 2nd edition of its GAMP Good Practice Guide on computerized GCP systems &amp; data - greatly expanded, with QFINITY on the author team.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:published_time\" content=\"2024-08-01T15:44:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-19T07:00:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:mN7M.c4bb\/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\" \/>\n\t<meta property=\"og:image:width\" content=\"844\" \/>\n\t<meta property=\"og:image:height\" content=\"802\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Maike Henrichmann\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Maike Henrichmann\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/\"},\"author\":{\"name\":\"Maike Henrichmann\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#\\\/schema\\\/person\\\/c9c2f17fa94bae30f5ec3b88bd3c798e\"},\"headline\":\"Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data\",\"datePublished\":\"2024-08-01T15:44:45+00:00\",\"dateModified\":\"2026-07-19T07:00:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/\"},\"wordCount\":224,\"publisher\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2024\\/08\\/Bildschirmfoto-2024-08-01-um-16.41.06.png\",\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/\",\"url\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/\",\"name\":\"GAMP Good Practice Guide GCP 2nd Edition | QFINITY\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/q-finity.de\\\/en\\\/publication-of-gamp-good-practice-guide-validation-and-compliance-of-computerized-gcp-systems-and-data\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\/\\/q-finity.de\\/wp-content\\/uploads\\/2024\\/08\\/Bildschirmfoto-2024-08-01-um-16.41.06.png\",\"datePublished\":\"2024-08-01T15:44:45+00:00\",\"dateModified\":\"2026-07-19T07:00:16+00:00\",\"description\":\"ISPE publishes the 2nd edition of its GAMP Good Practice Guide on computerized GCP systems & data - 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