{"id":1635,"date":"2025-03-04T20:48:37","date_gmt":"2025-03-04T12:48:37","guid":{"rendered":"https:\/\/cabit.top\/?p=1635"},"modified":"2025-03-04T20:48:59","modified_gmt":"2025-03-04T12:48:59","slug":"360045072211-has-geneious-prime-been-validated-does-it-comply-with-the-fda-regulation-21-cfr-part-11","status":"publish","type":"post","link":"https:\/\/cabit.top\/?p=1635","title":{"rendered":"Geneious Prime \u662f\u5426\u7ecf\u8fc7\u9a8c\u8bc1\uff1f\u5b83\u662f\u5426\u7b26\u5408 FDA \u6cd5\u89c4 21 CFR Part 11\uff1f"},"content":{"rendered":"\n<p>Geneious Prime \u4ec5\u7528\u4e8e\u7814\u7a76\u76ee\u7684\u3002\u5b83\u672a\u9488\u5bf9\u4e34\u5e8a\u5de5\u4f5c\u8fdb\u884c\u9a8c\u8bc1 &#8211; \u6700\u7ec8\u7528\u6237\u6709\u8d23\u4efb\u786e\u4fdd\u4efb\u4f55\u76f8\u5173\u7684\u5408\u89c4\u6027\u3002<\/p>\n\n\n\n<p>\u8bf7\u6ce8\u610f\uff0cGeneious \u7684\u5b89\u5168<a href=\"https:\/\/www.geneious.com\/security\" target=\"_blank\" rel=\"noreferrer noopener\">\u5b9e\u8df5<\/a>\u5df2\u83b7\u5f97\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7 \uff08ISO\uff09 27001\uff1a2022 \u8ba4\u8bc1\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h_01J19806PNFY1E95VWEKM4D894\">\u7ed3\u679c\u7684\u51c6\u786e\u6027<\/h3>\n\n\n\n<p>\u6211\u4eec\u4e3a Geneious \u8f6f\u4ef6\u7684\u8d28\u91cf\u611f\u5230\u81ea\u8c6a\uff0c\u5e76\u91c7\u53d6\u5408\u7406\u7684\u63aa\u65bd\u6765\u7ef4\u62a4\u5176\u4ea7\u751f\u7684\u7ed3\u679c\u7684\u51c6\u786e\u6027\u3002\u4f46\u662f\uff0c\u6211\u4eec\u4e0d\u80fd\u4fdd\u8bc1\u5728\u6240\u6709\u60c5\u51b5\u4e0b\u90fd\u662f\u6b63\u786e\u7684\u3002\u6211\u4eec\u9f13\u52b1\u5bf9\u7ed3\u679c\u6709\u9ad8\u5ea6\u4fe1\u5fc3\u7684\u7528\u6237\u4f7f\u7528\u5c3d\u53ef\u80fd\u63a5\u8fd1\u201c\u751f\u4ea7\u201d\u4e2d\u4f7f\u7528\u7684\u5de5\u5177\u3001\u6570\u636e\u548c\u53c2\u6570\u6765\u6267\u884c\u81ea\u5df1\u7684\u9a8c\u8bc1\u3002<\/p>\n\n\n\n<p>\u5982\u679c\u60a8\u53d1\u73b0 Genic \u751f\u6210\u7684\u7ed3\u679c\u7684\u51c6\u786e\u6027\u5b58\u5728\u4efb\u4f55\u95ee\u9898\uff0c\u8bf7<a href=\"https:\/\/support.geneious.com\/hc\/en-us\/requests\/new\" target=\"_blank\" rel=\"noreferrer noopener\">\u544a\u8bc9\u6211\u4eec<\/a>\uff0c\u56e0\u4e3a\u6211\u4eec\u975e\u5e38\u91cd\u89c6\u6b64\u7c7b\u95ee\u9898\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h_01J19806PN6V9SR49394K6Z0YG\">\u5ba1\u8ba1\u548c\u6570\u636e\u5b8c\u6574\u6027<\/h3>\n\n\n\n<p>\u65e0\u6cd5\u4fdd\u8bc1 Geneious Prime \u4e2d\u5b58\u50a8\u7684\u6570\u636e\u7684\u5b8c\u6574\u6027\u3002\u4f46\u662f\uff0cGeneious Prime \u786e\u5b9e\u63d0\u4f9b\u4e86\u53ef\u7528\u4e8e\u63d0\u9ad8\u6570\u636e\u5b8c\u6574\u6027\u7684\u529f\u80fd\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/geneious.com\/cloud\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Geneious Cloud<\/strong><\/a>\u00a0\u53ef\u7528\u4e8e\u5c06\u60a8\u7684\u6570\u636e\u5b58\u50a8\u5728\u6211\u4eec\u7684\u5b89\u5168\u4e91\u5e73\u53f0\u4e0a\uff0c\u5728\u8be5\u5e73\u53f0\u4e0a\uff0c\u53ef\u4ee5\u4f7f\u7528\u6743\u9650\u6765\u63a7\u5236\u8c01\u53ef\u4ee5\u8bbf\u95ee\u6bcf\u4e2a\u9879\u76ee\u3002<\/li>\n\n\n\n<li>\u6240\u6709\u00a0\u6587\u6863\u7684 History \u9009\u9879\u5361\uff08\u5728 Info \u9009\u9879\u5361\u4e0b\uff09\u63d0\u4f9b\u4e86\u5bf9\u6bcf\u4e2a\u6587\u6863\u8fdb\u884c\u66f4\u6539\u7684\u4eba\u5458\u548c\u65f6\u95f4\u7684\u8bb0\u5f55\u3002Geneious \u8fd8\u8bb0\u5f55\u521b\u5efa\/\u4e0a\u6b21\u7f16\u8f91\u6bcf\u4e2a\u6ce8\u91ca\u7684\u4eba\u5458\uff0c\u5e76\u901a\u8fc7\u4e16\u7cfb\u8ddf\u8e2a\uff08\u7236\/\u540e\u4ee3\u8ddf\u8e2a\uff09\u8ddf\u8e2a\u5bf9\u6587\u6863\u6267\u884c\u7684\u4f5c\u3002<\/li>\n\n\n\n<li>\u9ad8\u7ea7\u7ba1\u7406\u529f\u80fd\u5141\u8bb8\u5728\u6574\u4e2a\u8f6f\u4ef6\u4e2d\u9884\u8bbe\/\u9501\u5b9a\u67d0\u4e9b\u529f\u80fd\u548c\u8bbe\u7f6e\uff0c\u4ee5\u786e\u4fdd\u4f7f\u7528\u9002\u5f53\u7684\u5de5\u5177\/\u8bbe\u7f6e\u3002\u6709\u5173\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605\u00a0<a href=\"http:\/\/geneious.com\/manual\" target=\"_blank\" rel=\"noreferrer noopener\">Geneious \u624b\u518c<\/a>\u4e2d\u7684\u201c\u9ad8\u7ea7\u7ba1\u7406\u201d\u90e8\u5206\u3002\u00a0<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h_01J19806PPJD1C7R1N49CD582T\">\u9a8c\u8bc1\u6587\u4ef6<\/h3>\n\n\n\n<p>\u6211\u4eec\u6ca1\u6709\u4efb\u4f55\u53ef\u7528\u7684\u7279\u5b9a\u6587\u4ef6\u53ef\u4ee5\u5e2e\u52a9\u60a8\u5236\u4f5c\u81ea\u5df1\u7684\u9a8c\u8bc1\u6587\u4ef6\u3002\u6211\u4eec\u5efa\u8bae\u4f7f\u7528\u5c3d\u53ef\u80fd\u63a5\u8fd1\u201c\u751f\u4ea7\u201d\u4e2d\u4f7f\u7528\u7684\u5de5\u5177\u3001\u6570\u636e\u548c\u53c2\u6570\uff0c\u4f7f\u7528\u7279\u5b9a\u7248\u672c\u7684 Geneious Prime \u8bb0\u5f55\u60a8\u81ea\u5df1\u7684\u9a8c\u8bc1\u3002<br><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h_01J2CT78YTJZ45YC83K0VY4FEE\"><strong>ISO 27001 \u8ba4\u8bc1<br><\/strong><\/h3>\n\n\n\n<p>\u5728\u5bf9\u6211\u4eec\u7684\u4fe1\u606f\u5b89\u5168\u7ba1\u7406\u4f53\u7cfb \uff08ISMS\uff09 \u8fdb\u884c\u5916\u90e8\u5ba1\u67e5\u540e\uff0c\u6211\u4eec\u83b7\u5f97\u4e86 Schellman \u9881\u53d1\u7684\u56fd\u9645\u6807\u51c6\u5316\u7ec4\u7ec7 \uff08ISO\uff09 27001\uff1a2022 \u8ba4\u8bc1\u3002<\/p>\n\n\n\n<p>\u4e3a\u4e86\u83b7\u5f97 ISO 27001 \u8ba4\u8bc1\uff0c\u516c\u53f8\u5fc5\u987b\u8bc1\u660e\u5176\u62e5\u6709\u7cfb\u7edf\u4e14\u6301\u7eed\u7684\u65b9\u6cd5\u6765\u7ba1\u7406\u5f71\u54cd\u516c\u53f8\u548c\u5ba2\u6237\u4fe1\u606f\u7684\u673a\u5bc6\u6027\u3001\u5b8c\u6574\u6027\u548c\u53ef\u7528\u6027\u7684\u4fe1\u606f\u5b89\u5168\u98ce\u9669\u3002\u8be5\u6807\u51c6\u5f3a\u8c03\u5bf9\u7ec4\u7ec7\u4fe1\u606f\u5b89\u5168\u7ba1\u7406\u4f53\u7cfb \uff08ISMS\uff09 \u7684\u8861\u91cf\u548c\u8bc4\u4f30\u3002<\/p>\n\n\n\n<p>\u5728\u5916\u90e8\u5ba1\u8ba1\u671f\u95f4\uff0cSchellman \u8bc4\u4f30\u4e86\u9002\u7528\u4e8e Biomatters \u548c Geneious Biologics \u8fd0\u8425\u548c\u652f\u6301\u3001\u8f6f\u4ef6\u5f00\u53d1\u548c\u4e91\u6258\u7ba1\u7684 ISMS\uff0c\u53d1\u73b0\u6211\u4eec\u5728\u6240\u6709\u9886\u57df\u90fd\u8fbe\u5230\u6216\u8d85\u8fc7\u4e86\u6807\u51c6\u3002\u5ba1\u8ba1\u5e08\u5f97\u51fa\u7684\u7ed3\u8bba\u662f\uff0c\u5df2\u7ecf\u5b9e\u65bd\u4e86\u63a7\u5236\u63aa\u65bd\u6765\u4fdd\u62a4\u4fe1\u606f\u8d44\u4ea7\u514d\u53d7\u76f8\u5173\u98ce\u9669\u7684\u5f71\u54cd\uff0c\u5e76\u4e14\u8fd9\u4e9b\u63a7\u5236\u63aa\u65bd\u5f97\u5230\u4e86\u6709\u6548\u7684\u76d1\u63a7\u548c\u7ba1\u7406\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Geneious Prime \u4ec5&#46;&#46;&#46;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[],"class_list":["post-1635","post","type-post","status-publish","format-standard","hentry","category-geneious"],"_links":{"self":[{"href":"https:\/\/cabit.top\/index.php?rest_route=\/wp\/v2\/posts\/1635","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cabit.top\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cabit.top\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cabit.top\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cabit.top\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1635"}],"version-history":[{"count":1,"href":"https:\/\/cabit.top\/index.php?rest_route=\/wp\/v2\/posts\/1635\/revisions"}],"predecessor-version":[{"id":1636,"href":"https:\/\/cabit.top\/index.php?rest_route=\/wp\/v2\/posts\/1635\/revisions\/1636"}],"wp:attachment":[{"href":"https:\/\/cabit.top\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1635"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cabit.top\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1635"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cabit.top\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1635"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}