{"id":16061,"date":"2023-09-07T08:26:07","date_gmt":"2023-09-07T08:26:07","guid":{"rendered":"https:\/\/dev2.antsolutions.eu\/?p=16061"},"modified":"2025-11-28T12:26:42","modified_gmt":"2025-11-28T12:26:42","slug":"%e4%bf%9d%e6%8c%81%e6%95%b0%e6%8d%ae%e5%ae%8c%e6%95%b4%e6%80%a7-%e7%ac%a6%e5%90%88-cgmp-%e6%a0%87%e5%87%86","status":"publish","type":"post","link":"https:\/\/dev2.accevo.com\/zh\/blog\/maintaining-data-integrity-in-cgmp-compliance\/","title":{"rendered":"\u5728\u7b26\u5408 cGMP \u8981\u6c42\u7684\u8fc7\u7a0b\u4e2d\u4fdd\u6301\u6570\u636e\u7684\u5b8c\u6574\u6027"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"16061\" class=\"elementor elementor-16061\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2b4207bc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2b4207bc\" data-element_type=\"section\" 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class=\"wp-block-list\">\n<li><strong>\u57f9\u8bad\u4e0e\u6559\u80b2\uff1a<\/strong> \u5b9a\u671f\u5bf9\u5458\u5de5\u8fdb\u884c\u6570\u636e\u5b8c\u6574\u6027\u539f\u5219\u7684\u57f9\u8bad\uff0c\u5e76\u5f3a\u5316\u51c6\u786e\u8bb0\u5f55\u7684\u91cd\u8981\u6027\u3002\u5728\u7ec4\u7ec7\u5185\u90e8\u5efa\u7acb\u6570\u636e\u5b8c\u6574\u6027\u6587\u5316\u3002<\/li>\n\n\n\n<li><strong>\u81ea\u52a8\u5316\uff1a<\/strong> \u5b9e\u65bd\u81ea\u52a8\u6570\u636e\u91c7\u96c6\u548c\u8bb0\u5f55\u7cfb\u7edf\uff0c\u5c06\u4eba\u4e3a\u9519\u8bef\u7684\u98ce\u9669\u964d\u81f3\u6700\u4f4e\u3002\u8fd9\u4e9b\u7cfb\u7edf\u5177\u6709\u5b9e\u65f6\u6570\u636e\u76d1\u63a7\u548c\u62a5\u544a\u529f\u80fd\u3002<\/li>\n\n\n\n<li><strong>\u8bbf\u95ee\u63a7\u5236\uff1a<\/strong> 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\u5b9a\u671f\u5907\u4efd\u6570\u636e\uff0c\u9632\u6b62\u56e0\u6280\u672f\u6545\u969c\u6216\u6570\u636e\u635f\u574f\u800c\u4e22\u5931\u6570\u636e\u3002\u5b9e\u65bd\u6570\u636e\u6062\u590d\u8ba1\u5212\uff0c\u786e\u4fdd\u6570\u636e\u968f\u65f6\u53ef\u7528\u3002<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u76d1\u7ba1\u671f\u671b<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5305\u62ec FDA \u5728\u5185\u7684\u76d1\u7ba1\u673a\u6784\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u6709\u660e\u786e\u7684\u8981\u6c42\u3002\u9075\u5b88 21 CFR \u7b2c 211 \u90e8\u5206\uff08\u6d89\u53ca\u6210\u54c1\u836f\u7684 cGMP \u6cd5\u89c4\uff09\u548c 21 CFR \u7b2c 11 \u90e8\u5206\uff08\u7279\u522b\u6d89\u53ca\u7535\u5b50\u8bb0\u5f55\u548c\u7b7e\u540d\uff09\u662f\u81f3\u5173\u91cd\u8981\u7684\u3002\u4e25\u683c\u9075\u5b88\u8fd9\u4e9b\u6cd5\u89c4\u5bf9\u4e8e\u907f\u514d\u76d1\u7ba1\u884c\u52a8\u81f3\u5173\u91cd\u8981\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u603b\u7ed3<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u7b26\u5408 cGMP \u7684\u60c5\u51b5\u4e0b\u4fdd\u6301\u6570\u636e\u7684\u5b8c\u6574\u6027\u4e0d\u4ec5\u4ec5\u662f\u4e00\u9879\u76d1\u7ba1\u8981\u6c42\uff0c\u4e5f\u662f\u5236\u836f\u5546\u7684\u57fa\u672c\u9700\u8981\u3002\u6570\u636e\u5b8c\u6574\u6027\u906d\u5230\u7834\u574f\u7684\u540e\u679c\u53ef\u80fd\u4f1a\u5f88\u4e25\u91cd\uff0c\u5305\u62ec\u76d1\u7ba1\u884c\u52a8\u548c\u60a3\u8005\u5b89\u5168\u4e24\u65b9\u9762\u3002\u901a\u8fc7\u5b9e\u65bd\u6700\u4f73\u5b9e\u8df5\u3001\u6295\u8d44\u4e8e\u5458\u5de5\u57f9\u8bad\u548c\u5229\u7528\u6280\u672f\uff0c\u5236\u836f\u516c\u53f8\u53ef\u4ee5\u786e\u4fdd\u6574\u4e2a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u7684\u6570\u636e\u5b8c\u6574\u6027\u3002\u8fd9\u4e00\u627f\u8bfa\u4e0d\u4ec5\u80fd\u6ee1\u8db3\u76d1\u7ba1\u673a\u6784\u7684\u671f\u671b\uff0c\u8fd8\u80fd\u575a\u6301\u4ea7\u54c1\u8d28\u91cf\u548c\u60a3\u8005\u798f\u7949\u7684\u6700\u9ad8\u6807\u51c6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6709\u5173 cGMP \u5408\u89c4\u6027\u548c\u6570\u636e\u5b8c\u6574\u6027\u7684\u66f4\u591a\u4fe1\u606f\u3001\u6307\u5bfc\u548c\u89e3\u51b3\u65b9\u6848\uff0c\u8bf7\u8054\u7cfb Accevo \u3002\u6211\u4eec\u662f\u60a8\u503c\u5f97\u4fe1\u8d56\u7684\u5353\u8d8a\u5236\u836f\u5408\u4f5c\u4f19\u4f34\u3002<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-98ac3a2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"98ac3a2\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-93c4f2c\" data-id=\"93c4f2c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-61278ed elementor-widget elementor-widget-heading\" data-id=\"61278ed\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u4e0e\u6b64\u6587\u7ae0\u76f8\u5173\u7684\u4ea7\u54c1<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-669d872 elementor-grid-3 elementor-grid-tablet-2 elementor-grid-mobile-1 elementor-posts--thumbnail-top elementor-card-shadow-yes elementor-posts__hover-gradient elementor-widget elementor-widget-posts\" data-id=\"669d872\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;cards_columns&quot;:&quot;3&quot;,&quot;cards_columns_tablet&quot;:&quot;2&quot;,&quot;cards_columns_mobile&quot;:&quot;1&quot;,&quot;cards_row_gap&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:35,&quot;sizes&quot;:[]},&quot;cards_row_gap_laptop&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;cards_row_gap_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;cards_row_gap_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"posts.cards\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-posts-container elementor-posts elementor-posts--skin-cards elementor-grid\" role=\"list\">\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-1818 page type-page status-publish has-post-thumbnail hentry\" role=\"listitem\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/dev2.accevo.com\/zh\/products\/mes-manufacturing-execution-system\/\" tabindex=\"-1\"><div class=\"elementor-post__thumbnail\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web.jpg\" class=\"attachment-full size-full wp-image-24207\" alt=\"\" srcset=\"https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web.jpg 1920w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web-300x169.jpg 300w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web-1024x576.jpg 1024w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web-768x432.jpg 768w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web-1536x864.jpg 1536w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/MES-bg-2025-web-18x10.jpg 18w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" title=\"\"><\/div><\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/dev2.accevo.com\/zh\/products\/mes-manufacturing-execution-system\/\">\n\t\t\t\tMES \u7cfb\u7edf - \u5236\u9020\u6267\u884c\u7cfb\u7edf - Accevo\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>MES \u7cfb\u7edf\u2014\u2014\u5236\u9020\u6267\u884c\u7cfb\u7edf \u5229\u7528 MES \u7cfb\u7edf\u5bf9\u751f\u4ea7\u6d41\u7a0b\u8fdb\u884c\u76d1\u6d4b\u4e0e\u5206\u6790\uff0c\u5e76\u6307\u51fa\u53ef\u8fdb\u4e00\u6b65\u4f18\u5316\u7684\u73af\u8282 \u9884\u7ea6\u6f14\u793a<\/p>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-post__read-more-wrapper\">\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/dev2.accevo.com\/zh\/products\/mes-manufacturing-execution-system\/\" aria-label=\"Read more about MES System &#8211; Manufacturing Execution System &#8211; Accevo\" tabindex=\"-1\">\n\t\t\t\u9605\u8bfb\u66f4\u591a \"\t\t<\/a>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-6672 page type-page status-publish has-post-thumbnail hentry\" role=\"listitem\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/dev2.accevo.com\/zh\/products\/electronic-batch-records-ebr\/\" tabindex=\"-1\"><div class=\"elementor-post__thumbnail\"><img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web.jpg\" class=\"attachment-full size-full wp-image-24197\" alt=\"\" srcset=\"https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web.jpg 1920w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web-300x169.jpg 300w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web-1024x576.jpg 1024w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web-768x432.jpg 768w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web-1536x864.jpg 1536w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/EBR-bg-2025-web-18x10.jpg 18w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" title=\"\"><\/div><\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/dev2.accevo.com\/zh\/products\/electronic-batch-records-ebr\/\">\n\t\t\t\t\u7535\u5b50\u6279\u91cf\u8bb0\u5f55 (EBR) \u8f6f\u4ef6\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>\u7535\u5b50\u6279\u8bb0\u5f55 (EBR) \u8f6f\u4ef6\uff1a\u7b80\u5316\u6279\u6b21\u7ba1\u7406\u7684\u6570\u5b57\u5316\u89e3\u51b3\u65b9\u6848 \u7535\u5b50\u6279\u6b21\u8bb0\u5f55 (EBR) \u8f6f\u4ef6\u53d6\u4ee3\u4e86\u4f20\u7edf\u7684\u7eb8\u8d28\u6279\u6b21\u8bb0\u5f55\uff0c\u63d0\u4f9b\u6570\u5b57\u5316\u6307\u5bfc<\/p>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-post__read-more-wrapper\">\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/dev2.accevo.com\/zh\/products\/electronic-batch-records-ebr\/\" aria-label=\"Read more about Electronic Batch Records (EBR) Software\" tabindex=\"-1\">\n\t\t\t\u9605\u8bfb\u66f4\u591a \"\t\t<\/a>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-15798 page type-page status-publish has-post-thumbnail hentry\" role=\"listitem\">\n\t\t\t<div class=\"elementor-post__card\">\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/dev2.accevo.com\/zh\/laboratory-information-management-system-lims-system\/\" tabindex=\"-1\"><div class=\"elementor-post__thumbnail\"><img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web.jpg\" class=\"attachment-full size-full wp-image-24221\" alt=\"\" srcset=\"https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web.jpg 1920w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web-300x169.jpg 300w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web-1024x576.jpg 1024w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web-768x432.jpg 768w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web-1536x864.jpg 1536w, https:\/\/dev2.accevo.com\/wp-content\/uploads\/2025\/10\/lims-bg-2025-web-18x10.jpg 18w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" title=\"\"><\/div><\/a>\n\t\t\t\t<div class=\"elementor-post__text\">\n\t\t\t\t<h3 class=\"elementor-post__title\">\n\t\t\t<a href=\"https:\/\/dev2.accevo.com\/zh\/laboratory-information-management-system-lims-system\/\">\n\t\t\t\t\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf\uff08LIMS \u7cfb\u7edf\uff09\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t<div class=\"elementor-post__excerpt\">\n\t\t\t<p>\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf\uff08LIMS\uff09 LIMS \u53ef\u5b9e\u73b0\u5b9e\u9a8c\u5ba4\u64cd\u4f5c\u81ea\u52a8\u5316\uff0c\u63d0\u9ad8\u5de5\u4f5c\u6d41\u7a0b\u6548\u7387\u3002\u9884\u7ea6\u6f14\u793a Accevo LIMS Accevo \u4e3a\u60a8\u63d0\u4f9b\u6700\u5168\u9762\u7684\u5b9e\u9a8c\u5ba4\u4fe1\u606f<\/p>\n\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-post__read-more-wrapper\">\n\t\t\n\t\t<a class=\"elementor-post__read-more\" href=\"https:\/\/dev2.accevo.com\/zh\/laboratory-information-management-system-lims-system\/\" aria-label=\"Read more about Laboratory Information Management System (LIMS System)\" tabindex=\"-1\">\n\t\t\t\u9605\u8bfb\u66f4\u591a \"\t\t<\/a>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Data integrity is the linchpin of pharmaceutical manufacturing under Current Good Manufacturing Practices (cGMP). It ensures that data generated throughout the manufacturing process is accurate, reliable, and secure. In this comprehensive guide, we explore the critical role of data integrity in cGMP compliance. We&#8217;ll begin by providing a detailed explanation of cGMP, followed by the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":24705,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[30],"tags":[67],"class_list":["post-16061","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-quality"],"_links":{"self":[{"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/posts\/16061","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/comments?post=16061"}],"version-history":[{"count":0,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/posts\/16061\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/media\/24705"}],"wp:attachment":[{"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/media?parent=16061"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/categories?post=16061"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev2.accevo.com\/zh\/wp-json\/wp\/v2\/tags?post=16061"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}