{"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":"gamp-%e8%bd%af%e4%bb%b6%e6%9c%89%e5%93%aa%e4%ba%9b%e7%b1%bb%e5%88%ab%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/accevo.com\/zh\/glossary\/what-are-the-gamp-software-categories\/","title":{"rendered":"GAMP 5 \u8f6f\u4ef6\u7c7b\u522b"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>GAMP 5 \u8f6f\u4ef6\u7c7b\u522b<\/strong> \u5c06GxP\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u4e2d\u7684\u8f6f\u4ef6\u7ec4\u4ef6\u8fdb\u884c\u5206\u7ec4\uff0c\u4ee5\u5e2e\u52a9\u89c4\u5212\u4e00\u79cd\u9002\u5f53\u4e14\u57fa\u4e8e\u98ce\u9669\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u65b9\u6cd5\u3002\u76ee\u524d\u7684\u5206\u7c7b\u5982\u4e0b\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u7b2c1\u7c7b\u2014\u2014\u57fa\u7840\u8bbe\u65bd\u8f6f\u4ef6\u3001\u5de5\u5177\u548cIT\u670d\u52a1\uff1a<\/strong> \u4f8b\u5982\uff0c\u64cd\u4f5c\u7cfb\u7edf\u548c\u57fa\u7840\u8bbe\u65bd\u5e73\u53f0\u3002.<\/li>\n<li><strong>\u7b2c3\u7c7b\u2014\u2014\u672a\u914d\u7f6e\u7684\u4ea7\u54c1\uff1a<\/strong> \u8f6f\u4ef6\u6309\u539f\u6837\u4f7f\u7528\uff0c\u65e0\u9700\u8fdb\u884c\u7279\u5b9a\u4e8e\u5e94\u7528\u7a0b\u5e8f\u7684\u914d\u7f6e\u3002.<\/li>\n<li><strong>\u7b2c4\u7c7b\u2014\u2014\u914d\u7f6e\u578b\u4ea7\u54c1\uff1a<\/strong> \u7ecf\u8fc7\u914d\u7f6e\u4ee5\u652f\u6301\u65e2\u5b9a\u4e1a\u52a1\u6d41\u7a0b\u7684\u8f6f\u4ef6\u3002.<\/li>\n<li><strong>\u7b2c5\u7c7b\u2014\u2014\u5b9a\u5236\u5e94\u7528\u7a0b\u5e8f\uff1a<\/strong> \u6839\u636e\u7279\u5b9a\u7528\u6237\u9700\u6c42\u5f00\u53d1\u7684\u8f6f\u4ef6\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u5f53\u524d\u7684 GAMP 5 \u8f6f\u4ef6\u5206\u7c7b\u4e2d\uff0c\u4e0d\u4f7f\u7528\u7b2c 2 \u7c7b\u3002\u7b2c 3 \u7c7b\u81f3\u7b2c 5 \u7c7b\u6784\u6210\u4e00\u4e2a\u8fde\u7eed\u4f53\uff0c\u4ec5\u51ed\u7c7b\u522b\u672c\u8eab\u65e0\u6cd5\u786e\u5b9a\u9a8c\u8bc1\u5de5\u4f5c\u91cf\u3002\u56e2\u961f\u5e94\u6839\u636e\u9884\u671f\u7528\u9014\u3001\u7cfb\u7edf\u590d\u6742\u6027\u4ee5\u53ca\u5bf9\u4ea7\u54c1\u8d28\u91cf\u3001\u60a3\u8005\u5b89\u5168\u548c\u6570\u636e\u5b8c\u6574\u6027\u7684\u98ce\u9669\uff0c\u76f8\u5e94\u8c03\u6574\u4fdd\u8bc1\u6c34\u5e73\u3002\u53c2\u89c1 <a href=\"https:\/\/ispe.org\/GAMP-Training\" target=\"_blank\" rel=\"noreferrer noopener nofollow\">ISPE\u7684GAMP\u6307\u5357<\/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\/zh\/wp-json\/wp\/v2\/posts\/23337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/comments?post=23337"}],"version-history":[{"count":2,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/23337\/revisions"}],"predecessor-version":[{"id":38236,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/posts\/23337\/revisions\/38236"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/media\/24364"}],"wp:attachment":[{"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/media?parent=23337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/categories?post=23337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/accevo.com\/zh\/wp-json\/wp\/v2\/tags?post=23337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}