{"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":"cuales-son-las-categorias-del-software-gamp","status":"publish","type":"post","link":"https:\/\/accevo.com\/es\/glossary\/what-are-the-gamp-software-categories\/","title":{"rendered":"Categor\u00edas de software de GAMP 5"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Categor\u00edas de software de GAMP 5<\/strong> agrupar los componentes de software en los sistemas informatizados GxP para facilitar la planificaci\u00f3n de un enfoque adecuado del ciclo de vida basado en el riesgo. Las categor\u00edas actuales son:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Categor\u00eda 1 \u2014 Software de infraestructura, herramientas y servicios inform\u00e1ticos:<\/strong> por ejemplo, los sistemas operativos y las plataformas de infraestructura.<\/li>\n<li><strong>Categor\u00eda 3 \u2014 Productos sin configurar:<\/strong> software utilizado tal y como se suministra, sin configuraci\u00f3n espec\u00edfica para la aplicaci\u00f3n.<\/li>\n<li><strong>Categor\u00eda 4 \u2014 Productos configurados:<\/strong> software configurado para dar soporte a procesos empresariales definidos.<\/li>\n<li><strong>Categor\u00eda 5 \u2014 Aplicaciones personalizadas:<\/strong> software desarrollado para satisfacer las necesidades espec\u00edficas de los usuarios.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">La categor\u00eda 2 no se utiliza en la clasificaci\u00f3n actual de software de GAMP 5. Las categor\u00edas 3 a 5 forman un continuo, y una categor\u00eda por s\u00ed sola no determina el esfuerzo de validaci\u00f3n. Los equipos deben adaptar el nivel de garant\u00eda al uso previsto, a la complejidad del sistema y al riesgo para la calidad del producto, la seguridad del paciente y la integridad de los datos. V\u00e9ase <a href=\"https:\/\/ispe.org\/GAMP-Training\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">Directrices GAMP de la ISPE<\/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\/es\/wp-json\/wp\/v2\/posts\/23337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/comments?post=23337"}],"version-history":[{"count":2,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/posts\/23337\/revisions"}],"predecessor-version":[{"id":38236,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/posts\/23337\/revisions\/38236"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/media\/24364"}],"wp:attachment":[{"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/media?parent=23337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/categories?post=23337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/accevo.com\/es\/wp-json\/wp\/v2\/tags?post=23337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}