{"id":16660,"date":"2026-07-18T13:00:17","date_gmt":"2026-07-18T11:00:17","guid":{"rendered":"https:\/\/q-finity.de\/glossar\/gamp-5-begriff\/"},"modified":"2026-07-19T21:03:03","modified_gmt":"2026-07-19T19:03:03","slug":"gamp-5","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/gamp-5\/","title":{"rendered":"GAMP 5"},"content":{"rendered":"<p>GAMP 5 &ndash; &ldquo;A Risk-Based Approach to Compliant GxP Computerized Systems&rdquo; &ndash; is ISPE&rsquo;s industry guide for computerized system validation: published in 2008, since 2022 in its Second Edition, which strengthens <a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">Critical Thinking<\/a> and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements &ndash; GAMP shows a proven way to meet them. The FDA has pointed to GAMP for orientation for more than two decades: in 2003, its Part 11 guidance named the GAMP 4 Guide as an industry reference for validation; the final CSA guidance (2025) added a reference to the Second Edition. QFINITY helped create the Second Edition.<\/p>\n<p><em>See also: <a href=\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\" target=\"_self\" title=\"Computer Software Assurance is the FDA's risk-based approach for establishing and maintaining confidence that software is fit for its Intended Use - in the guidance's own wording, the Intended Use of the software as part of production or the quality management system, explicitly distinguished from the intended use of the medical device itself. The effort&hellip;\" class=\"encyclopedia\">Computer Software Assurance (CSA)<\/a>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/csv-vs-csa\/\" target=\"_self\" title='CSV (Computerized System Validation) and CSA (Computer Software Assurance) are not an either-or: CSA does not replace CSV. The final FDA guidance (2025) merely supersedes Section 6 of the FDA guidance \"General Principles of Software Validation\" and takes over the field of production and QMS software; for software that is itself part of a medical&hellip;' class=\"encyclopedia\">CSV vs. CSA<\/a>, <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system-validation\/\" target=\"_self\" title=\"Computerized system validation describes achieving and maintaining compliance with applicable GxP and Medical Device regulations and establishing documented evidence that the system is fit for intended use by: the adoption of principles, approaches, and life cycle activities within the validation framework by executing project specific validation plans establishing and applying&nbsp;appropriate operational controls throughout the life&hellip;\" class=\"encyclopedia\">Computerized System Validation<\/a>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>GAMP 5 &#8211; &#8220;A Risk-Based Approach to Compliant GxP Computerized Systems&#8221; &#8211; is ISPE&#8217;s industry guide for computerized system validation: published in 2008, since 2022 in its Second Edition, which strengthens Critical Thinking and scaled evidence. GAMP is industry good practice, not law: regulations set the requirements &#8211; GAMP shows a proven way to meet [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-16660","encyclopedia","type-encyclopedia","status-publish","hentry"],"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 5 &#187; QFINITY<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GAMP 5\" \/>\n<meta property=\"og:description\" content=\"GAMP 5 &#8211; &#8220;A Risk-Based Approach to Compliant GxP Computerized Systems&#8221; &#8211; is ISPE&#8217;s industry guide for computerized system validation: published in 2008, since 2022 in its Second Edition, which strengthens Critical Thinking and scaled evidence. 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