{"id":23337,"date":"2025-05-15T11:32:20","date_gmt":"2025-05-15T11:32:20","guid":{"rendered":"https:\/\/dev.accevosystems.com\/?p=23337"},"modified":"2025-10-23T07:42:49","modified_gmt":"2025-10-23T07:42:49","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:\/\/dev2.accevo.com\/zh\/glossary\/what-are-the-gamp-software-categories\/","title":{"rendered":"\u4ec0\u4e48\u662f GAMP \u8f6f\u4ef6\u7c7b\u522b\uff1f"},"content":{"rendered":"<p class=\"wp-block-paragraph\">GAMP 5 \u63d0\u4f9b\u4e86\u76f8\u5173\u6307\u5bfc\uff0c\u5305\u62ec\u4e3a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u5efa\u7acb\u7edf\u4e00\u7684\u8bed\u8a00\u548c\u672f\u8bed\u4f53\u7cfb\u3002\u8be5\u6307\u5bfc\u5305\u542b\u5bf9 GAMP \u8f6f\u4ef6\u7c7b\u522b\u7684\u5b9a\u4e49\u3002\u8fd9\u4e9b\u7c7b\u522b\u7528\u4e8e\u5bf9\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u8f6f\u4ef6\u7ec4\u4ef6\u8fdb\u884c\u5206\u7c7b\u3002\u9a8c\u8bc1\u6d3b\u52a8\u7684\u7ea7\u522b\u548c\u4ea4\u4ed8\u6210\u679c\u53ef\u4f9d\u636e\u8fd9\u4e9b\u7c7b\u522b\u786e\u5b9a\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">GAMP \u8f6f\u4ef6\u7c7b\u522b\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u7b2c1\u7c7b\uff1a\u57fa\u7840\u8bbe\u65bd\u8f6f\u4ef6\u3002\u5176\u4e2d\u5305\u62ecIT\u57fa\u7840\u8bbe\u65bd\u5de5\u5177\uff0c\u4ee5\u53ca\u64cd\u4f5c\u7cfb\u7edf\uff08OS\uff09\u3001\u6570\u636e\u5e93\uff08DB\uff09\u548c\u4e2d\u95f4\u4ef6\u7b49\u5c42\u7ea7\u8f6f\u4ef6\u3002.<\/li>\n\n\n\n<li>\u7b2c2\u7c7b\uff1a\u8be5\u7c7b\u522b\u73b0\u5df2\u4e0d\u518d\u4f7f\u7528\u3002.<\/li>\n\n\n\n<li>\u7b2c3\u7c7b\uff1a\u672a\u914d\u7f6e\u7684\u4ea7\u54c1\u3002\u4f8b\u5982\u57fa\u4e8e\u56fa\u4ef6\u7684\u5e94\u7528\u7a0b\u5e8f\u3001COTS\uff08\u5546\u7528\u73b0\u6210\uff09\u8f6f\u4ef6\u4ee5\u53ca\u4eea\u5668\u8bbe\u5907\u3002.<\/li>\n\n\n\n<li>\u7b2c4\u7c7b\uff1a\u914d\u7f6e\u578b\u4ea7\u54c1\u3002\u8be5\u7c7b\u522b\u6db5\u76d6ERP\uff08\u4f01\u4e1a\u8d44\u6e90\u8ba1\u5212\uff09\u3001EDMS\uff08\u7535\u5b50\u6587\u6863\u7ba1\u7406\u7cfb\u7edf\uff09\u3001LIMS\uff08\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf\uff09\u4ee5\u53ca\u7535\u5b50\u8868\u683c\u7b49\u7cfb\u7edf\u3002.<\/li>\n\n\n\n<li>\u7b2c 5 \u7c7b\uff1a\u81ea\u5b9a\u4e49\u5e94\u7528\u7a0b\u5e8f\u3002\u8be5\u7c7b\u522b\u7684\u793a\u4f8b\u5305\u62ec\u4e13\u7528\u5e94\u7528\u7a0b\u5e8f\u3001\u81ea\u5b9a\u4e49\u56fa\u4ef6\u4ee5\u53ca\u4f7f\u7528\u5b8f\u7684\u7535\u5b50\u8868\u683c\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6839\u636eGAMP 5\u7684\u89c4\u5b9a\uff0c\u5236\u9020\u6267\u884c\u7cfb\u7edf\uff08MES\uff09\u88ab\u5f52\u7c7b\u4e3a\u7b2c4\u7c7b\uff0c\u800c\u5bf9\u8be5\u7cfb\u7edf\u7684\u5b9a\u5236\u5316\u5219\u88ab\u89c6\u4e3a\u7b2c4\u7c7b\u3002MES\u7cfb\u7edf\u7684\u9a8c\u8bc1\u65b9\u6cd5\u57fa\u4e8e\u5176\u6839\u636eGAMP\u88ab\u5f52\u7c7b\u4e3a\u8f6f\u4ef6\u7b2c4-5\u7c7b\u8fd9\u4e00\u4e8b\u5b9e<\/p>","protected":false},"excerpt":{"rendered":"<p>GAMP 5 provides guidance, including establishing a common language and terminology for computerized systems. This guidance includes the definition of GAMP Software Categories. These categories are used to classify the software component of a computerized system. The level of validation activities and deliverables can be derived from these categories. The GAMP software categories are: A [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":24364,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"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:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/posts\/23337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/comments?post=23337"}],"version-history":[{"count":0,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/posts\/23337\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/media\/24364"}],"wp:attachment":[{"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/media?parent=23337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/categories?post=23337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/tags?post=23337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}