{"id":23337,"date":"2025-05-15T11:32:20","date_gmt":"2025-05-15T11:32:20","guid":{"rendered":"https:\/\/dev.accevosystems.com\/?p=23337"},"modified":"2026-09-23T10:53:29","modified_gmt":"2026-09-23T10:53:29","slug":"what-are-the-gamp-software-categories","status":"publish","type":"post","link":"https:\/\/accevo.com\/pl\/glossary\/what-are-the-gamp-software-categories\/","title":{"rendered":"Kategorie oprogramowania GAMP 5"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>GAMP 5 software categories<\/strong> group software components in GxP computerized systems to help plan an appropriate, risk-based lifecycle approach. The current categories are:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Category 1 \u2014 Infrastructure software, tools, and IT services:<\/strong> for example, operating systems and infrastructure platforms.<\/li>\n<li><strong>Category 3 \u2014 Non-configured products:<\/strong> software used as supplied, without application-specific configuration.<\/li>\n<li><strong>Category 4 \u2014 Configured products:<\/strong> software configured to support defined business processes.<\/li>\n<li><strong>Category 5 \u2014 Custom applications:<\/strong> software developed for specific user requirements.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Category 2 is not used in the current GAMP 5 software classification. Categories 3\u20135 are a continuum, and a category alone does not determine validation effort. Teams should scale assurance to intended use, system complexity, and risk to product quality, patient safety, and data integrity. See <a href=\"https:\/\/ispe.org\/GAMP-Training\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISPE\u2019s GAMP guidance<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>GAMP 5 software categories group software components in GxP computerized systems to help plan an appropriate, risk-based lifecycle approach. The current categories are: Category 1 \u2014 Infrastructure software, tools, and IT services: for example, operating systems and infrastructure platforms. Category 3 \u2014 Non-configured products: software used as supplied, without application-specific configuration. Category 4 \u2014 Configured [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":24364,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"wpai_generated_summary":"","footnotes":""},"categories":[32],"tags":[],"class_list":["post-23337","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-glossary"],"_links":{"self":[{"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/posts\/23337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/comments?post=23337"}],"version-history":[{"count":2,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/posts\/23337\/revisions"}],"predecessor-version":[{"id":38236,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/posts\/23337\/revisions\/38236"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/media\/24364"}],"wp:attachment":[{"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/media?parent=23337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/categories?post=23337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/accevo.com\/pl\/wp-json\/wp\/v2\/tags?post=23337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}