{"id":1578,"date":"2026-05-30T10:34:37","date_gmt":"2026-05-30T02:34:37","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=1578"},"modified":"2026-05-30T10:34:37","modified_gmt":"2026-05-30T02:34:37","slug":"engineering-management-tools-review-13","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13","title":{"rendered":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u4e0e\u6838\u5fc3\u5de5\u5177\u6df1\u5ea6\u6d4b\u8bc4"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_83 counter-hierarchy ez-toc-counter ez-toc-light-blue ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%9A%84%E6%96%B0%E6%8C%91%E6%88%98%E4%B8%8E%E7%A0%B4%E5%B1%80%E4%B9%8B%E9%81%93\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7684\u65b0\u6311\u6218\u4e0e\u7834\u5c40\u4e4b\u9053<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%E6%A0%B8%E5%BF%83%E9%80%89%E5%9E%8B%E7%BB%B4%E5%BA%A6\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u9009\u578b\u7ef4\u5ea6<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#%E4%B8%BB%E6%B5%81%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%85%A8%E6%99%AF%E9%80%9F%E8%A7%88\" >\u4e3b\u6d41\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u5168\u666f\u901f\u89c8<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\u6df1\u5ea6\u6d4b\u8bc4<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#ONES\" >ONES<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#Tower\" >Tower<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#Jira\" >Jira<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#Azure_DevOps\" >Azure DevOps<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#Helix_ALM\" >Helix ALM<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#Jama_Connect\" >Jama Connect<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%80%BB%E7%BB%93\" >\u9009\u578b\u5efa\u8bae\u4e0e\u603b\u7ed3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#FAQ%EF%BC%9A2026%E5%B9%B4%E5%B7%A5%E5%85%B7%E9%80%89%E5%9E%8B%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98\" >FAQ\uff1a2026\u5e74\u5de5\u5177\u9009\u578b\u5e38\u89c1\u95ee\u9898<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%EF%BC%9F%E5%A6%82%E4%BD%95%E5%8F%82%E8%80%83%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f\u5982\u4f55\u53c2\u8003\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#%E4%B8%BA%E4%BB%80%E4%B9%88%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%E2%80%9C%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%E2%80%9D%EF%BC%9F\" >\u4e3a\u4ec0\u4e48\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7279\u522b\u5f3a\u8c03\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u201c\u8ffd\u6eaf\u80fd\u529b\u201d\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#Jira%E8%83%BD%E5%90%A6%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E7%9A%84%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%EF%BC%9F\" >Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u884c\u4e1a\u7684\u5408\u89c4\u8981\u6c42\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-13\/#%E5%9B%BD%E4%BA%A7%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%E5%9C%A8%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E6%9C%89%E5%93%AA%E4%BA%9B%E4%BC%98%E5%8A%BF%EF%BC%9F\" >\u56fd\u4ea7\u7814\u53d1\u7ba1\u7406\u5de5\u5177\u5728\u533b\u7597\u884c\u4e1a\u6709\u54ea\u4e9b\u4f18\u52bf\uff1f<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%9A%84%E6%96%B0%E6%8C%91%E6%88%98%E4%B8%8E%E7%A0%B4%E5%B1%80%E4%B9%8B%E9%81%93\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7684\u65b0\u6311\u6218\u4e0e\u7834\u5c40\u4e4b\u9053<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u968f\u7740\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u6570\u5b57\u5316\u8f6c\u578b\u7684\u6301\u7eed\u6df1\u5316\uff0c2026\u5e74\u7684\u7814\u53d1\u7ba1\u7406\u6b63\u9762\u4e34\u524d\u6240\u672a\u6709\u7684\u5408\u89c4\u538b\u529b\u4e0e\u534f\u540c\u6311\u6218\u3002\u4ece\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7684\u8fed\u4ee3\u5230\u521b\u65b0\u836f\u7814\u7684\u6570\u636e\u8ffd\u6eaf\uff0c\u4f01\u4e1a\u4e0d\u4ec5\u9700\u8981\u6ee1\u8db3FDA 21 CFR Part 11\u3001ISO 13485\u7b49\u4e25\u82db\u6cd5\u89c4\u8981\u6c42\uff0c\u8fd8\u9700\u5728\u654f\u6377\u4ea4\u4ed8\u4e0e\u8d28\u91cf\u98ce\u9669\u4e4b\u95f4\u627e\u5230\u5e73\u8861\u3002\u8bb8\u591a\u7814\u53d1\u8d1f\u8d23\u4eba\u5e38\u95ee\uff1a\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f\u54ea\u6b3e\u5de5\u5177\u80fd\u771f\u6b63\u517c\u987e\u5408\u89c4\u4e0e\u6548\u7387\uff1f\u672c\u6587\u5c06\u56f4\u7ed5\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u4e3b\u8f74\uff0c\u4e3a\u60a8\u7cfb\u7edf\u68b3\u7406\u9009\u578b\u903b\u8f91\uff0c\u5e76\u5bf9\u4e3b\u6d41\u5de5\u5177\u8fdb\u884c\u6df1\u5ea6\u5256\u6790\uff0c\u52a9\u529b\u4f01\u4e1a\u6784\u5efa\u5408\u89c4\u3001\u9ad8\u6548\u3001\u53ef\u8ffd\u6eaf\u7684\u7814\u53d1\u7ba1\u7406\u4f53\u7cfb\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%E6%A0%B8%E5%BF%83%E9%80%89%E5%9E%8B%E7%BB%B4%E5%BA%A6\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u9009\u578b\u7ef4\u5ea6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\uff0c\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u9009\u578b\u7edd\u4e0d\u80fd\u4ec5\u770b\u529f\u80fd\u4e30\u5bcc\u5ea6\uff0c\u800c\u5fc5\u987b\u5c06\u884c\u4e1a\u7279\u6027\u4f5c\u4e3a\u7b2c\u4e00\u51c6\u5219\u3002\u6211\u4eec\u57fa\u4e8e2026\u5e74\u7684\u884c\u4e1a\u5408\u89c4\u6807\u51c6\u4e0e\u6280\u672f\u8d8b\u52bf\uff0c\u63d0\u70bc\u51fa\u4ee5\u4e0b\u56db\u5927\u6838\u5fc3\u6d4b\u8bc4\u7ef4\u5ea6\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bc4\u7ef4\u5ea6<\/th>\n<th>\u5173\u952e\u8003\u91cf\u70b9<\/th>\n<th>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7279\u5f02\u6027\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b<\/td>\n<td>\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff08RTM\uff09\u3001\u7535\u5b50\u7b7e\u540d\u3001\u5ba1\u8ba1\u65e5\u5fd7<\/td>\n<td>\u5fc5\u987b\u6ee1\u8db3FDA 21 CFR Part 11\u53caIEC 62304\u6807\u51c6\uff0c\u5b9e\u73b0\u7aef\u5230\u7aef\u53cc\u5411\u8ffd\u6eaf<\/td>\n<\/tr>\n<tr>\n<td>\u8d28\u91cf\u4e0e\u98ce\u9669\u7ba1\u7406<\/td>\n<td>CAPA\u7ba1\u7406\u3001FMEA\u3001\u7f3a\u9677\u5173\u8054\u4e0e\u95ed\u73af<\/td>\n<td>\u9700\u5c06\u98ce\u9669\u63a7\u5236\u5d4c\u5165\u7814\u53d1\u6d41\u7a0b\uff0c\u786e\u4fdd\u8d28\u91cf\u4f53\u7cfb\u7b26\u5408ISO 13485\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u654f\u6377\u4e0e\u5de5\u7a0b\u534f\u540c<\/td>\n<td>\u591a\u5c42\u7ea7\u8ba1\u5212\u3001\u8de8\u804c\u80fd\u534f\u540c\u3001DevOps\u96c6\u6210<\/td>\n<td>\u652f\u6301\u6df7\u5408\u6a21\u5f0f\uff08\u654f\u6377+\u7011\u5e03\uff09\uff0c\u6253\u901a\u8f6f\u786c\u4ef6\u7814\u53d1\u58c1\u5792<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u5168\u4e0e\u6743\u9650\u7ba1\u63a7<\/td>\n<td>\u6570\u636e\u52a0\u5bc6\u3001\u7ec6\u7c92\u5ea6\u89d2\u8272\u6743\u9650\u3001\u79c1\u6709\u5316\u90e8\u7f72<\/td>\n<td>\u4fdd\u969c\u60a3\u8005\u6570\u636e\u4e0e\u6838\u5fc3IP\u5b89\u5168\uff0c\u6ee1\u8db3HIPAA\u53ca\u672c\u5730\u6570\u636e\u51fa\u5883\u6cd5\u89c4<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%BB%E6%B5%81%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%85%A8%E6%99%AF%E9%80%9F%E8%A7%88\"><\/span>\u4e3b\u6d41\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u5168\u666f\u901f\u89c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u660e\u786e\u9009\u578b\u7ef4\u5ea6\u540e\uff0c\u6211\u4eec\u9488\u5bf9\u5e02\u573a\u4e0a\u5907\u53d7\u5173\u6ce8\u76846\u6b3e\u6838\u5fc3\u5de5\u5177\u8fdb\u884c\u5168\u666f\u6982\u89c8\uff0c\u5e2e\u52a9\u60a8\u5feb\u901f\u5efa\u7acb\u521d\u6b65\u8ba4\u77e5\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u56fd\u4ea7\u5168\u80fd\u578b\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u63d0\u4f9b\u5f3a\u5927\u7684\u7aef\u5230\u7aef\u8ffd\u6eaf\u4e0e\u4f01\u4e1a\u7ea7\u6743\u9650\u7ba1\u63a7\uff0c\u9002\u914d\u56fd\u5185\u533b\u7597\u5408\u89c4\u8bc9\u6c42\uff0c\u652f\u6301\u6df7\u5408\u6a21\u578b\u4e0e\u79c1\u6709\u5316\u90e8\u7f72\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u8f7b\u91cf\u7ea7\u534f\u540c\u5de5\u5177\uff0c\u754c\u9762\u76f4\u89c2\u6613\u4e0a\u624b\uff0c\u9002\u5408\u521d\u521b\u578b\u533b\u7597\u56e2\u961f\u7684\u57fa\u7840\u9879\u76ee\u7ba1\u7406\uff0c\u4f46\u5728\u6df1\u5ea6\u5408\u89c4\u8ffd\u6eaf\u4e0a\u9700\u8f85\u4ee5\u989d\u5916\u5de5\u5177\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u5168\u7403\u5e94\u7528\u6700\u5e7f\u6cdb\u7684\u654f\u6377\u7ba1\u7406\u5de5\u5177\uff0c\u751f\u6001\u4e30\u5bcc\uff0c\u901a\u8fc7\u63d2\u4ef6\u53ef\u5b9e\u73b0\u90e8\u5206\u8ffd\u6eaf\u9700\u6c42\uff0c\u4f46\u914d\u7f6e\u6210\u672c\u8f83\u9ad8\uff0c\u5408\u89c4\u5f00\u7bb1\u5373\u7528\u80fd\u529b\u504f\u5f31\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u4e0b\u7684DevOps\u5229\u5668\uff0c\u63d0\u4f9b\u4ece\u8ba1\u5212\u5230\u4ea4\u4ed8\u7684\u5b8c\u6574\u5de5\u5177\u94fe\uff0c\u9002\u5408\u91cd\u5ea6\u4f9d\u8d56C#\/.NET\u6280\u672f\u6808\u4e14\u5177\u5907\u81ea\u5efa\u5408\u89c4\u6d41\u6c34\u7ebf\u80fd\u529b\u7684\u533b\u7597\u56e2\u961f\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e3a\u9ad8\u5408\u89c4\u884c\u4e1a\u8bbe\u8ba1\u7684\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u5185\u7f6e\u9700\u6c42\u8ffd\u6eaf\u4e0e\u6d4b\u8bd5\u7ba1\u7406\uff0c\u662f\u533b\u7597\u5668\u68b0\u4e0e\u8f66\u8f7d\u7cfb\u7edf\u7b49\u4e25\u76d1\u7ba1\u9886\u57df\u7684\u4f20\u7edf\u9996\u9009\u3002<\/li>\n<li><strong>Jama Connect<\/strong>\uff1a\u805a\u7126\u590d\u6742\u4ea7\u54c1\u7814\u53d1\u7684\u9700\u6c42\u7ba1\u7406\u4e0e\u98ce\u9669\u5206\u6790\u5e73\u53f0\uff0c\u5176Industry Solution\u4e3a\u533b\u7597\u884c\u4e1a\u63d0\u4f9b\u9884\u7f6e\u7684\u5408\u89c4\u6846\u67b6\u4e0e\u6307\u5357\uff0c\u5927\u5e45\u964d\u4f4e\u9a8c\u8bc1\u6210\u672c\u3002<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\u6df1\u5ea6\u6d4b\u8bc4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"ONES\"><\/span><a href=\"https:\/\/ones.cn\/\" target=\"_blank\" rel=\"noopener noreferrer\">ONES<\/a><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5<\/strong>\uff1aONES\u4f5c\u4e3a\u56fd\u5185\u9886\u5148\u7684\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u57282026\u5e74\u5df2\u6784\u5efa\u8d77\u8986\u76d6\u9879\u76ee\u96c6\u3001\u9879\u76ee\u6267\u884c\u5230\u6548\u80fd\u5ea6\u91cf\u7684\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u95ed\u73af\u3002\u5176\u67b6\u6784\u8bbe\u8ba1\u517c\u987e\u9ad8\u5ea6\u6807\u51c6\u5316\u4e0e\u7075\u6d3b\u914d\u7f6e\uff0c\u4e3a\u533b\u7597\u5065\u5eb7\u7b49\u5f3a\u76d1\u7ba1\u884c\u4e1a\u63d0\u4f9b\u4e86\u575a\u5b9e\u7684\u6570\u5b57\u5316\u5e95\u5ea7\uff0c\u52a9\u529b\u4f01\u4e1a\u5b9e\u73b0\u4ece\u9700\u6c42\u89c4\u5212\u5230\u4ea4\u4ed8\u9a8c\u8bc1\u7684\u5168\u94fe\u8def\u900f\u660e\u5316\u7ba1\u63a7\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1aONES\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u4e0a\u7684\u6838\u5fc3\u4f18\u52bf\uff0c\u6df1\u5ea6\u5951\u5408\u8be5\u884c\u4e1a\u5bf9\u5408\u89c4\u3001\u8ffd\u6eaf\u4e0e\u534f\u540c\u7684\u4e25\u82db\u8981\u6c42\uff0c\u5177\u4f53\u4f53\u73b0\u5728\u4ee5\u4e0b\u4e09\u70b9\uff1a<\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u9700\u6c42\u8ffd\u6eaf\u94fe\u8def<\/strong>\uff1a\u652f\u6301\u4ece\u4e34\u5e8a\u9700\u6c42\u3001\u4ea7\u54c1\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u786e\u4fdd\u6bcf\u4e00\u9879\u533b\u7597\u529f\u80fd\u5747\u5177\u5907\u660e\u786e\u7684\u6765\u6e90\u4e0e\u9a8c\u8bc1\u4f9d\u636e\uff0c\u8f7b\u677e\u5e94\u5bf9FDA\u4e0eNMPA\u7684\u5ba1\u8ba1\u6838\u67e5\u3002<\/li>\n<li><strong>\u5f3a\u5408\u89c4\u4e0e\u6587\u6863\u7ba1\u63a7\u673a\u5236<\/strong>\uff1a\u5185\u7f6e\u57fa\u7ebf\u7ba1\u7406\u4e0e\u7535\u5b50\u7b7e\u540d\u80fd\u529b\uff0c\u4fdd\u969c\u8bbe\u8ba1\u5386\u53f2\u6587\u4ef6\uff08DHF\uff09\u4e0e\u4ea7\u54c1\u5386\u53f2\u8bb0\u5f55\uff08DHR\uff09\u7684\u4e0d\u53ef\u7be1\u6539\u6027\uff0c\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7684\u5408\u89c4\u95ed\u73af\u8981\u6c42\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u534f\u540c\u4e0e\u6548\u80fd\u6d1e\u5bdf<\/strong>\uff1a\u6253\u901a\u8f6f\u786c\u4ef6\u7814\u53d1\u4e0e\u6ce8\u518c\u6cd5\u89c4\u56e2\u961f\u7684\u534f\u4f5c\u58c1\u5792\uff0c\u901a\u8fc7\u5168\u5c40\u770b\u677f\u5b9e\u65f6\u76d1\u63a7\u7814\u53d1\u8fdb\u5ea6\u4e0e\u5408\u89c4\u98ce\u9669\uff0c\u786e\u4fdd\u5408\u89c4\u6d3b\u52a8\u4e0e\u654f\u6377\u5f00\u53d1\u540c\u9891\u5171\u632f\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9ad8\u5ea6\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7814\u53d1\u3001\u6570\u5b57\u7597\u6cd5\u4ea7\u54c1\u4ea4\u4ed8\u53ca\u533b\u836f\u4fe1\u606f\u5316\u7cfb\u7edf\u5efa\u8bbe\u7b49\u573a\u666f\u3002\u5c24\u5176\u9002\u5408\u9700\u8981\u517c\u987e\u654f\u6377\u8fed\u4ee3\u4e0e\u4e25\u683c\u5408\u89c4\u5ba1\u67e5\uff0c\u4e14\u9762\u4e34\u9891\u7e41\u5ba1\u8ba1\u538b\u529b\u7684\u4e2d\u5927\u578b\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\uff0c\u4f5c\u4e3a\u5176\u7edf\u4e00\u7814\u53d1\u7ba1\u7406\u4e2d\u67a2\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1aONES\u7684\u6838\u5fc3\u4eae\u70b9\u5728\u4e8e\u5c06\u590d\u6742\u7684\u5408\u89c4\u8981\u6c42\u65e0\u7f1d\u878d\u5165\u654f\u6377\u7814\u53d1\u6d41\u7a0b\uff0c\u800c\u975e\u5f62\u6210\u6d41\u7a0b\u963b\u788d\u3002\u9009\u578b\u4eba\u5458\u53ef\u4f18\u5148\u542f\u7528\u5176\u9884\u7f6e\u7684\u533b\u7597\u5408\u89c4\u9879\u76ee\u6a21\u677f\u4e0e\u8ffd\u6eaf\u77e9\u9635\u7ec4\u4ef6\uff0c\u5728\u4fdd\u969c\u5ba1\u8ba1\u5408\u89c4\u7684\u540c\u65f6\uff0c\u5207\u5b9e\u63d0\u5347\u8de8\u90e8\u95e8\u4ea4\u4ed8\u6548\u7387\uff0c\u5b9e\u73b0\u5408\u89c4\u4e0e\u6548\u80fd\u7684\u53cc\u8d62\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/04f5ddf81ca3_ONES-\u4ea7\u54c1\u5168\u666f\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+ONES \u4ea7\u54c1\u5168\u666f\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Tower\"><\/span>Tower<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>\u4f5c\u4e3a\u56fd\u5185\u8f83\u65e9\u5165\u5c40\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u5e73\u53f0\uff0cTower\u4ee5\u654f\u6377\u4efb\u52a1\u6d41\u8f6c\u4e0e\u9879\u76ee\u8fdb\u5ea6\u53ef\u89c6\u5316\u89c1\u957f\u3002\u5176\u8bbe\u8ba1\u54f2\u5b66\u504f\u5411\u201c\u6781\u7b80\u4e0e\u9ad8\u6548\u201d\uff0c\u901a\u8fc7\u770b\u677f\u3001\u7518\u7279\u56fe\u4e0e\u591a\u7ef4\u7edf\u8ba1\u89c6\u56fe\uff0c\u4e3a\u4e2d\u5c0f\u578b\u56e2\u961f\u63d0\u4f9b\u4f4e\u95e8\u69db\u7684\u5728\u7ebf\u534f\u540c\u73af\u5883\uff0c\u5728\u4e92\u8054\u7f51\u53ca\u901a\u7528\u578b\u9879\u76ee\u7ba1\u7406\u4e2d\u62e5\u6709\u5e7f\u6cdb\u7684\u7528\u6237\u57fa\u7840\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong>\u5728\u533b\u7597\u5065\u5eb7\u8fd9\u4e00\u5f3a\u5408\u89c4\u3001\u91cd\u8ffd\u6eaf\u7684\u9886\u57df\uff0cTower\u7684\u5e95\u5c42\u80fd\u529b\u7565\u663e\u5355\u8584\uff0c\u5176\u6838\u5fc3\u80fd\u529b\u66f4\u591a\u4f53\u73b0\u5728\u5916\u56f4\u534f\u4f5c\u4e0e\u8f7b\u91cf\u7ea7\u654f\u6377\u63a8\u8fdb\u4e0a\uff1a<\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u654f\u6377\u63a8\u8fdb\uff1a<\/strong>\u652f\u6301Scrum\u4e0e\u770b\u677f\u6a21\u5f0f\uff0c\u80fd\u5e2e\u52a9\u533b\u7597\u8f6f\u4ef6\u524d\u7aef\u7684\u4ea4\u4e92\u56e2\u961f\u5feb\u901f\u8fed\u4ee3\uff0c\u4f46\u5728\u6df1\u6c34\u533a\u7684\u5408\u89c4\u6d41\u8f6c\u4e0a\u7f3a\u4e4f\u539f\u751f\u652f\u6301\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u57fa\u7840\u534f\u540c\uff1a<\/strong>\u63d0\u4f9b\u6587\u6863\u534f\u540c\u4e0e\u4efb\u52a1\u6307\u6d3e\uff0c\u53ef\u6ee1\u8db3\u4e34\u5e8a\u8c03\u7814\u3001\u5e02\u573a\u4e0e\u7814\u53d1\u4e4b\u95f4\u7684\u521d\u6b65\u4fe1\u606f\u540c\u6b65\uff0c\u964d\u4f4e\u8de8\u90e8\u95e8\u6c9f\u901a\u635f\u8017\u3002<\/li>\n<li><strong>\u6807\u51c6\u5316\u6a21\u677f\u590d\u7528\uff1a<\/strong>\u5185\u7f6e\u9879\u76ee\u6a21\u677f\u80fd\u5feb\u901f\u642d\u5efa\u5e38\u89c4\u7814\u53d1\u7ed3\u6784\uff0c\u4f46\u5bf9\u4e8e\u533b\u7597\u5668\u68b0\u6240\u9700\u7684\u7279\u5b9a\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff08V&amp;V\uff09\u6d41\u7a0b\uff0c\u9700\u5927\u91cf\u624b\u52a8\u914d\u7f6e\u4e0e\u53d8\u901a\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5065\u5eb7\u4ea7\u4e1a\u94fe\u4e2d\u5408\u89c4\u538b\u529b\u8f83\u5c0f\u7684\u524d\u7aef\u5e94\u7528\u5f00\u53d1\uff08\u5982\u5065\u5eb7\u7ba1\u7406App\u3001\u8f7b\u91cf\u7ea7\u95ee\u8bca\u5c0f\u7a0b\u5e8f\uff09\uff0c\u6216\u4f5c\u4e3a\u5927\u578b\u533b\u7597\u8bbe\u5907\u56fa\u4ef6\u5f00\u53d1\u56e2\u961f\u4e2d\u975e\u6838\u5fc3\u5408\u89c4\u6a21\u5757\u7684\u8f85\u52a9\u4efb\u52a1\u534f\u540c\u5de5\u5177\uff0c\u4e0d\u5efa\u8bae\u4f5c\u4e3a\u53d7\u76d1\u7ba1\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u5408\u89c4\u4e3b\u6570\u636e\u6e90\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5b66\u4e60\u66f2\u7ebf\u6781\u4f4e\uff0c\u56e2\u961f\u53ef\u5728\u4e00\u4e24\u5929\u5185\u5feb\u901f\u4e0a\u624b\uff1b\u8ba2\u9605\u6210\u672c\u53ef\u63a7\uff0c\u5bf9\u521d\u521b\u533b\u7597\u56e2\u961f\u53cb\u597d\uff1b\u754c\u9762\u4ea4\u4e92\u6e05\u6670\uff0c\u80fd\u6709\u6548\u89e3\u51b3\u57fa\u7840\u4efb\u52a1\u8ddf\u8fdb\u4e0e\u8fdb\u5ea6\u900f\u660e\u5316\u95ee\u9898\u3002\u4f46\u5728\u9762\u5bf9FDA 21 CFR Part 11\u6216ISO 13485\u7b49\u4e25\u82db\u5ba1\u8ba1\u8981\u6c42\u65f6\uff0c\u5176\u8ffd\u6eaf\u6df1\u5ea6\u4e0e\u7535\u5b50\u7b7e\u540d\u63a7\u5236\u5b58\u5728\u660e\u663e\u77ed\u677f\uff0c\u9009\u578b\u4eba\u5458\u9700\u5ba1\u614e\u8bc4\u4f30\u5408\u89c4\u8fb9\u754c\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/966458e0716a_Tower-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Tower \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira\"><\/span>Jira<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>\u4f5c\u4e3a\u5168\u7403\u5e94\u7528\u6700\u5e7f\u6cdb\u7684\u7814\u53d1\u7ba1\u7406\u5de5\u5177\uff0cJira \u51ed\u501f\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684 Issue \u673a\u5236\u4e0e\u5de5\u4f5c\u6d41\u5f15\u64ce\uff0c\u6784\u5efa\u4e86\u5e9e\u5927\u7684\u63d2\u4ef6\u751f\u6001\u3002\u5386\u7ecf\u4e8c\u5341\u5e74\u6f14\u8fdb\uff0c\u5b83\u5df2\u6210\u4e3a\u590d\u6742\u8f6f\u4ef6\u5de5\u7a0b\u7ba1\u7406\u7684\u5e95\u5c42\u57fa\u7840\u8bbe\u65bd\uff0c\u4f46\u5728\u5782\u76f4\u884c\u4e1a\u7684\u5f00\u7bb1\u5373\u7528\u6027\u4e0a\u9010\u6e10\u663e\u9732\u51fa\u914d\u7f6e\u6210\u672c\u8fc7\u9ad8\u7684\u77ed\u677f\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u53ef\u8ffd\u6eaf\u6027\u4e0e\u53d8\u66f4\u7ba1\u63a7\uff1a<\/strong>\u4f9d\u8d56 Zephyr \u7b49\u5e02\u573a\u63d2\u4ef6\uff0c\u53ef\u642d\u5efa\u4ece\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u4f46\u539f\u751f\u7cfb\u7edf\u7f3a\u4e4f\u7b26\u5408 FDA 21 CFR Part 11 \u89c4\u8303\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff0c\u5408\u89c4\u95ed\u73af\u9700\u5927\u91cf\u4e8c\u6b21\u5f00\u53d1\u3002<\/li>\n<li><strong>\u590d\u6742\u8d28\u91cf\u4f53\u7cfb\u9002\u914d\uff1a<\/strong>\u5176\u5de5\u4f5c\u6d41\u5f15\u64ce\u80fd\u7cbe\u51c6\u6620\u5c04 ISO 13485 \u7b49\u8d28\u91cf\u4f53\u7cfb\u7684\u5ba1\u6279\u6d41\u8f6c\uff0c\u901a\u8fc7\u5b57\u6bb5\u4e0e\u72b6\u6001\u7ea6\u675f\u5b9e\u73b0\u7814\u53d1\u6d41\u7a0b\u7684\u5f3a\u7ba1\u63a7\uff0c\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u9636\u6bb5\u6027\u8bc4\u5ba1\u8981\u6c42\u3002<\/li>\n<li><strong>\u591a\u89d2\u8272\u534f\u540c\u4e0e ALM \u8986\u76d6\uff1a<\/strong>\u501f\u52a9 Xray \u7b49\u6269\u5c55\u53ef\u5b9e\u73b0\u6d4b\u8bd5\u7ba1\u7406\u95ed\u73af\uff0c\u4f46\u5728\u9700\u6c42\u57fa\u7ebf\u5316\u4e0e\u98ce\u9669\u63a7\u5236\u7ef4\u5ea6\uff0c\u4ecd\u9700\u5f15\u5165\u5916\u90e8\u65b9\u6848\u62fc\u51d1\uff0c\u6574\u4f53 ALM \u5b8c\u6574\u5ea6\u4e0d\u53ca\u5782\u76f4\u5546\u4e1a\u5de5\u5177\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u5177\u5907\u6210\u719f IT \u6cbb\u7406\u4f53\u7cfb\u3001\u62e5\u6709\u4e13\u804c Jira \u7ba1\u7406\u5458\u4e14\u9884\u7b97\u5145\u8db3\u53ef\u91c7\u8d2d\u5408\u89c4\u63d2\u4ef6\u7684\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff1b\u5bf9\u4e8e\u5408\u89c4\u8981\u6c42\u4e25\u82db\u4f46\u7814\u53d1\u56e2\u961f\u89c4\u6a21\u6709\u9650\u7684\u533b\u7597\u5668\u68b0\u521d\u521b\u516c\u53f8\uff0c\u5176\u9690\u6027\u7684\u914d\u7f6e\u4e0e\u7ef4\u62a4\u6210\u672c\u5f80\u5f80\u96be\u4ee5\u627f\u53d7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5de5\u4f5c\u6d41\u5f15\u64ce\u6781\u5ea6\u7075\u6d3b\uff0c\u63d2\u4ef6\u751f\u6001\u65e0\u53ef\u5339\u654c\uff0c\u5168\u7403\u5f00\u53d1\u8005\u4eba\u624d\u6c60\u6df1\u539a\u3002\u7136\u800c\uff0c\u533b\u7597\u5408\u89c4\u5e76\u975e\u5176\u539f\u751f\u57fa\u56e0\uff0c\u9009\u578b\u4eba\u5458\u9700\u6e05\u9192\u8bc4\u4f30\uff1a\u7528 Jira \u62fc\u51d1\u5408\u89c4\u4f53\u7cfb\uff0c\u672c\u8d28\u662f\u9ad8\u6602\u7684\u96c6\u6210\u5de5\u7a0b\uff0c\u5207\u52ff\u4f4e\u4f30\u5176\u957f\u671f\u8fd0\u7ef4\u4ee3\u4ef7\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/e2b0188e556d_Jira-\u4ea7\u54c1\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Jira \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Azure_DevOps\"><\/span>Azure DevOps<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Azure DevOps\u662f\u5fae\u8f6f\u63a8\u51fa\u7684\u4f01\u4e1a\u7ea7DevOps\u5e73\u53f0\uff0c\u63d0\u4f9b\u4ece\u9700\u6c42\u89c4\u5212\u3001\u4ee3\u7801\u7ba1\u7406\u3001CI\/CD\u5230\u6d4b\u8bd5\u76d1\u63a7\u7684\u7aef\u5230\u7aef\u5de5\u5177\u94fe\u3002\u51ed\u501f\u5176\u5f3a\u5927\u7684\u751f\u6001\u6574\u5408\u4e0e\u9ad8\u53ef\u7528\u7684\u4e91\u57fa\u7840\u8bbe\u65bd\uff0c\u6210\u4e3a\u4f17\u591a\u5927\u578b\u4f01\u4e1a\u6784\u5efa\u7814\u53d1\u6d41\u6c34\u7ebf\u7684\u6838\u5fc3\u5e95\u5ea7\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u5408\u89c4\u4e0e\u5ba1\u8ba1\u8ffd\u6eaf\uff1a<\/strong>Azure DevOps\u63d0\u4f9b\u4e0d\u53ef\u7be1\u6539\u7684\u5ba1\u8ba1\u65e5\u5fd7\u4e0e\u7cbe\u7ec6\u7684\u6743\u9650\u63a7\u5236\u4f53\u7cfb\uff0c\u53ef\u5b8c\u6574\u8bb0\u5f55\u9700\u6c42\u53d8\u66f4\u4e0e\u4ee3\u7801\u63d0\u4ea4\u8f68\u8ff9\uff0c\u4e3a\u533b\u7597\u8f6f\u4ef6\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u5408\u89c4\u5ba1\u67e5\u63d0\u4f9b\u6570\u636e\u652f\u6491\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u5b89\u5168\u4e0e\u6570\u636e\u9690\u79c1\uff1a<\/strong>\u4f9d\u6258Microsoft\u5408\u89c4\u77e9\u9635\uff0c\u5e73\u53f0\u81ea\u5e26\u6570\u767e\u9879\u5b89\u5168\u5408\u89c4\u8ba4\u8bc1\uff0c\u652f\u6301\u6570\u636e\u9a7b\u7559\u4e0e\u52a0\u5bc6\u9694\u79bb\uff0c\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u6570\u636e\u9ad8\u4fdd\u5bc6\u6027\u8981\u6c42\u3002<\/li>\n<li><strong>\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong>\u901a\u8fc7\u5de5\u4f5c\u9879\u3001PR\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u7684\u6df1\u5ea6\u5173\u8054\uff0c\u5b9e\u73b0\u4ece\u7528\u6237\u9700\u6c42\u5230\u90e8\u7f72\u53d1\u5e03\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u786e\u4fdd\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u8fc7\u7a0b\u7684\u95ed\u73af\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5177\u5907\u4e00\u5b9a\u7814\u53d1\u6210\u719f\u5ea6\u3001\u4ee5\u5fae\u8f6f\u6280\u672f\u6808\u4e3a\u4e3b\u4e14\u5bf9\u6570\u636e\u5b89\u5168\u5408\u89c4\u6709\u4e25\u82db\u8981\u6c42\u7684\u5927\u578b\u533b\u7597IT\u4f01\u4e1a\u6216\u8de8\u56fd\u836f\u4f01\u6570\u5b57\u5316\u56e2\u961f\uff0c\u5c24\u5176\u9002\u5408\u9700\u6784\u5efa\u590d\u6742CI\/CD\u6d41\u6c34\u7ebf\u4e0e\u91cd\u5ea6\u4f9d\u8d56Azure\u4e91\u670d\u52a1\u7684\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u6574\u5408\u80fd\u529b\u6781\u5f3a\uff0c\u4e0eGitHub\u3001Visual Studio\u53ca\u7b2c\u4e09\u65b9\u5b89\u5168\u626b\u63cf\u5de5\u5177\u65e0\u7f1d\u5bf9\u63a5\uff1bAzure Pipelines\u53ef\u9ad8\u6548\u6267\u884c\u9ad8\u5e76\u53d1\u81ea\u52a8\u5316\u6784\u5efa\uff1b\u6743\u9650\u6a21\u578b\u4e0e\u9879\u76ee\u96c6\u5408\u67b6\u6784\u80fd\u7cbe\u51c6\u652f\u6491\u8de8\u90e8\u95e8\u3001\u8de8\u5730\u57df\u7684\u5927\u578b\u533b\u7597\u7814\u53d1\u534f\u540c\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/6c6e0ea47749_Azure-DevOps-\u4ea7\u54c1\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Azure DevOps \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_ALM\"><\/span>Helix ALM<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Helix ALM \u662f\u4e00\u6b3e\u4e13\u7cbe\u4e8e\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5e73\u53f0\uff0c\u5176\u5e95\u5c42\u67b6\u6784\u8bbe\u8ba1\u5929\u7136\u5951\u5408\u5f3a\u76d1\u7ba1\u8bc9\u6c42\u3002\u5b83\u5c06\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u7ba1\u7406\u4e0e\u7f3a\u9677\u8ffd\u8e2a\u6df1\u5ea6\u6574\u5408\u4e8e\u540c\u4e00\u6570\u636e\u6a21\u578b\u4e2d\uff0c\u4e3a\u590d\u6742\u4ea7\u54c1\u7814\u53d1\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u53ef\u8ffd\u6eaf\u6027\u652f\u6491\uff0c\u662f\u4f20\u7edf\u91cd\u5408\u89c4\u9886\u57df\u7684\u8d44\u6df1\u73a9\u5bb6\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u95ed\u73af\uff1a<\/strong>\u63d0\u4f9b\u4ece\u9700\u6c42\u3001\u6e90\u7801\u81f3\u6d4b\u8bd5\u7528\u4f8b\u7684\u7ec6\u7c92\u5ea6\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u4e0eIEC 62304\u5bf9\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u4e25\u82db\u8981\u6c42\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u5ba1\u67e5\u963b\u529b\u3002<\/li>\n<li><strong>\u7535\u5b50\u7b7e\u540d\u4e0e\u9a8c\u8bc1\u5c31\u7eea\uff1a<\/strong>\u5185\u7f6e\u7b26\u5408\u89c4\u8303\u7684\u7535\u5b50\u7b7e\u540d\u673a\u5236\u4e0e\u64cd\u4f5c\u5f3a\u5236\u786e\u8ba4\u6d41\u7a0b\uff0c\u7cfb\u7edf\u672c\u8eab\u63d0\u4f9b\u9a8c\u8bc1\u5c31\u7eea\u5305\uff0c\u663e\u8457\u7f29\u77ed\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u521d\u59cb\u9a8c\u8bc1\u5468\u671f\u3002<\/li>\n<li><strong>\u57fa\u7ebf\u5316\u4e0e\u914d\u7f6e\u7ba1\u63a7\uff1a<\/strong>\u652f\u6301\u6587\u6863\u4e0e\u4ee3\u7801\u7684\u5f3a\u57fa\u7ebf\u7ba1\u7406\uff0c\u786e\u4fdd\u7814\u53d1\u5404\u9636\u6bb5\u4ea7\u7269\u72b6\u6001\u9501\u5b9a\uff0c\u6ee1\u8db3\u533b\u7597\u4ea7\u54c1\u53d8\u66f4\u63a7\u5236\u7684\u5408\u89c4\u5e95\u7ebf\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u3001\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\u53ca\u751f\u547d\u79d1\u5b66\u4eea\u5668\u7684\u5d4c\u5165\u5f0f\u8f6f\u4ef6\u7814\u53d1\u3002\u5c24\u5176\u9002\u5408\u9762\u4e34FDA\u6216CE\u4e25\u82db\u5ba1\u8ba1\u3001\u4e14\u5fc5\u987b\u8f93\u51fa\u5b8c\u6574\u9a8c\u8bc1\u6587\u6863\u7684\u4f20\u7edf\u7814\u53d1\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6846\u67b6\u4e0e\u6781\u81f4\u7684\u8ffd\u6eaf\u9897\u7c92\u5ea6\uff0c\u80fd\u5c06\u5408\u89c4\u6210\u672c\u8f6c\u5316\u4e3a\u5de5\u7a0b\u8d44\u4ea7\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u4ea4\u4e92\u4f53\u9a8c\u504f\u5411\u4f20\u7edf\uff0c\u654f\u6377\u652f\u6301\u8f83\u5f31\uff0c\u5bf9\u8ffd\u6c42\u8f7b\u5feb\u8fed\u4ee3\u7684\u6570\u5b57\u533b\u7597\u56e2\u961f\u800c\u8a00\u5b66\u4e60\u66f2\u7ebf\u504f\u9661\uff0c\u9009\u578b\u65f6\u9700\u5728\u5408\u89c4\u521a\u6027\u4e0e\u654f\u6377\u5f39\u6027\u95f4\u5ba1\u614e\u6743\u8861\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/48afb5ec2fd9_Helix-ALM-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Helix ALM \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jama_Connect\"><\/span>Jama Connect<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Jama Connect \u662f\u4e00\u6b3e\u4e13\u6ce8\u4e8e\u590d\u6742\u4ea7\u54c1\u4e0e\u7cfb\u7edf\u5de5\u7a0b\u7684\u9700\u6c42\u4e0e\u98ce\u9669\u7ba1\u7406\u5e73\u53f0\u3002\u5b83\u4ee5\u9700\u6c42\u5b9a\u4e49\u4e3a\u6838\u5fc3\uff0c\u901a\u8fc7\u7aef\u5230\u7aef\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u4e3a\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u7814\u53d1\u63d0\u4f9b\u7ed3\u6784\u5316\u652f\u6491\uff0c\u800c\u975e\u4f20\u7edf\u610f\u4e49\u4e0a\u7684\u6cdb\u7528\u578b\u9879\u76ee\u534f\u4f5c\u5de5\u5177\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u9700\u6c42\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong>\u63d0\u4f9b\u4ece\u7528\u6237\u9700\u6c42\u3001\u8bbe\u8ba1\u89c4\u8303\u5230\u6d4b\u8bd5\u9a8c\u8bc1\u7684\u5b9e\u65f6\u53cc\u5411\u8ffd\u6eaf\uff0c\u8fd9\u662f\u6ee1\u8db3FDA 21 CFR Part 820\u4e0eIEC 62304\u5408\u89c4\u5ba1\u8ba1\u7684\u786c\u6027\u57fa\u7840\uff0c\u80fd\u5927\u5e45\u964d\u4f4e\u5ba1\u67e5\u88ab\u62d2\u98ce\u9669\u3002<\/li>\n<li><strong>\u5185\u7f6e\u98ce\u9669\u4e0e\u5371\u5bb3\u5206\u6790\uff1a<\/strong>\u539f\u751f\u96c6\u6210FMEA\u4e0eDFMEA\u5206\u6790\u6846\u67b6\uff0c\u652f\u6301\u5728\u9700\u6c42\u5b9a\u4e49\u9636\u6bb5\u540c\u6b65\u5f00\u5c55\u5371\u5bb3\u5206\u6790\uff0c\u786e\u4fdd\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u4e0e\u5177\u4f53\u9700\u6c42\u76f4\u63a5\u6302\u94a9\uff0c\u6ee1\u8db3ISO 14971\u533b\u7597\u98ce\u9669\u7ba1\u7406\u6807\u51c6\u3002<\/li>\n<li><strong>\u7ed3\u6784\u5316\u8bc4\u5ba1\u4e0e\u7535\u5b50\u7b7e\u540d\uff1a<\/strong>\u652f\u6301\u7b26\u540821 CFR Part 11\u7535\u5b50\u8bb0\u5f55\u4e0e\u7b7e\u540d\u89c4\u8303\u7684\u5ba1\u6279\u6d41\uff0c\u786e\u4fdd\u9700\u6c42\u57fa\u7ebf\u53d8\u66f4\u7684\u5408\u89c4\u6027\u4e0e\u4e0d\u53ef\u62b5\u8d56\u6027\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u533b\u7597\u5668\u68b0\uff08\u7279\u522b\u662fClass II\/III\u7c7b\u6709\u6e90\u8bbe\u5907\uff09\u4e0e\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u4ea7\u54c1\u7684\u8f6f\u786c\u4ef6\u9700\u6c42\u4e0e\u98ce\u9669\u7ba1\u7406\uff0c\u4ee5\u53ca\u9700\u8981\u9891\u7e41\u5e94\u5bf9FDA\u3001NMPA\u7b49\u4e25\u82db\u5408\u89c4\u5ba1\u8ba1\u7684\u7814\u53d1\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u5c06\u9700\u6c42\u3001\u98ce\u9669\u4e0e\u6d4b\u8bd5\u9a8c\u8bc1\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u5f62\u6210\u95ed\u73af\u8bc1\u636e\u94fe\uff0c\u76f4\u63a5\u8f93\u51fa\u5408\u89c4\u62a5\u544a\uff0c\u663e\u8457\u7f29\u77ed\u5ba1\u8ba1\u51c6\u5907\u5468\u671f\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\uff0c\u4e14\u5728\u654f\u6377\u8fed\u4ee3\u4e0e\u65e5\u5e38\u4efb\u52a1\u534f\u540c\u7684\u7075\u6d3b\u6027\u4e0a\u4e0d\u53ca\u8f7b\u91cf\u7ea7\u5de5\u5177\uff0c\u9009\u578b\u65f6\u9700\u6743\u8861\u5408\u89c4\u521a\u6027\u4e0e\u56e2\u961f\u654f\u6377\u8bc9\u6c42\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/8fd2c4b79fe5_Jama-Connect-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417+Jama Connect \u4ea7\u54c1\u56fe\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%80%BB%E7%BB%93\"><\/span>\u9009\u578b\u5efa\u8bae\u4e0e\u603b\u7ed3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9488\u5bf9\u4e0d\u540c\u89c4\u6a21\u4e0e\u53d1\u5c55\u9636\u6bb5\u7684\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\uff0c\u6211\u4eec\u63d0\u51fa\u4ee5\u4e0b\u53ef\u6267\u884c\u7684\u9009\u578b\u5efa\u8bae\uff1a<\/p>\n<p>1. <strong>\u521d\u521b\u53ca\u4e2d\u5c0f\u578b\u533b\u7597\u56e2\u961f<\/strong>\uff1a\u82e5\u6838\u5fc3\u75db\u70b9\u5728\u4e8e\u8de8\u90e8\u95e8\u4efb\u52a1\u534f\u540c\u4e0e\u654f\u6377\u8fed\u4ee3\uff0c\u53ef\u4f18\u5148\u8bc4\u4f30 <strong>Tower<\/strong> \u6216 <strong>Jira<\/strong>\uff0c\u4ee5\u8f83\u4f4e\u6210\u672c\u5b9e\u73b0\u7814\u53d1\u8fc7\u7a0b\u53ef\u89c6\u5316\uff0c\u540e\u7eed\u968f\u5408\u89c4\u538b\u529b\u589e\u52a0\u518d\u884c\u96c6\u6210\u4e13\u4e1aALM\u5de5\u5177\u3002<\/p>\n<p>2. <strong>\u6210\u957f\u578b\u4e0e\u672c\u571f\u5316\u533b\u7597\u4f01\u4e1a<\/strong>\uff1a\u82e5\u9700\u517c\u987e\u654f\u6377\u5f00\u53d1\u4e0e\u56fd\u5185\u5408\u89c4\u8ffd\u6eaf\uff0c\u4e14\u8981\u6c42\u5feb\u901f\u843d\u5730\u4e0e\u672c\u5730\u5316\u670d\u52a1\u652f\u6301\uff0c<strong>ONES<\/strong> \u662f\u6027\u4ef7\u6bd4\u6781\u9ad8\u7684\u9009\u62e9\uff0c\u5176\u5f00\u7bb1\u5373\u7528\u7684\u8ffd\u6eaf\u77e9\u9635\u4e0e\u6743\u9650\u4f53\u7cfb\u80fd\u6709\u6548\u5e94\u5bf9\u5ba1\u8ba1\u3002<\/p>\n<p>3. <strong>\u5927\u578b\u533b\u7597\u5668\u68b0\u4e0e\u9ad8\u5408\u89c4\u8981\u6c42\u4f01\u4e1a<\/strong>\uff1a\u82e5\u4ea7\u54c1\u6d89\u53ca\u751f\u547d\u652f\u6301\u6216\u9ad8\u98ce\u9669\u7c7b\u522b\uff0c\u5fc5\u987b\u4e25\u683c\u9075\u5faaIEC 62304\u4e0eFDA\u6cd5\u89c4\uff0c<strong>Jama Connect<\/strong> \u4e0e <strong>Helix ALM<\/strong> \u662f\u6700\u7a33\u59a5\u7684\u8def\u5f84\uff0c\u5b83\u4eec\u63d0\u4f9b\u7684\u884c\u4e1a\u9884\u7f6e\u6a21\u677f\u80fd\u6781\u5927\u7f29\u77edIQ\/OQ\/PQ\u9a8c\u8bc1\u5468\u671f\u3002<\/p>\n<p>4. <strong>\u91cd\u5ea6\u4e91\u539f\u751f\u4e0eDevOps\u9a71\u52a8\u56e2\u961f<\/strong>\uff1a\u82e5\u7814\u53d1\u6d41\u7a0b\u5df2\u6df1\u5ea6\u7ed1\u5b9a\u5fae\u8f6f\u751f\u6001\u4e14\u5177\u5907\u8f83\u5f3a\u7684\u5de5\u7a0b\u5316\u80fd\u529b\uff0c<strong>Azure DevOps<\/strong> \u7ed3\u5408\u5b9a\u5236\u5316\u5408\u89c4\u6d41\u6c34\u7ebf\uff0c\u80fd\u5b9e\u73b0\u4ece\u4ee3\u7801\u5230\u90e8\u7f72\u7684\u9ad8\u5ea6\u81ea\u52a8\u5316\u7ba1\u63a7\u3002<\/p>\n<p>\u603b\u7ed3\u800c\u8a00\uff0c2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u7814\u53d1\u7ba1\u7406\u5df2\u6b65\u5165\u6df1\u6c34\u533a\uff0c\u5de5\u5177\u4e0d\u4ec5\u662f\u6548\u7387\u7684\u52a0\u901f\u5668\uff0c\u66f4\u662f\u5408\u89c4\u7684\u62a4\u57ce\u6cb3\u3002\u660e\u786e\u81ea\u8eab\u7684\u5408\u89c4\u57fa\u7ebf\u4e0e\u4e1a\u52a1\u75db\u70b9\uff0c\u9009\u62e9\u4e0e\u80fd\u529b\u4e3b\u8f74\u76f8\u5339\u914d\u7684\u7cfb\u7edf\uff0c\u624d\u80fd\u771f\u6b63\u8ba9\u7814\u53d1\u7ba1\u7406\u6210\u4e3a\u533b\u7597\u521b\u65b0\u7684\u6838\u5fc3\u9a71\u52a8\u529b\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"FAQ%EF%BC%9A2026%E5%B9%B4%E5%B7%A5%E5%85%B7%E9%80%89%E5%9E%8B%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98\"><\/span>FAQ\uff1a2026\u5e74\u5de5\u5177\u9009\u578b\u5e38\u89c1\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%8E%92%E8%A1%8C%E6%A6%9C%E6%9C%89%E5%90%97%EF%BC%9F%E5%A6%82%E4%BD%95%E5%8F%82%E8%80%83%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u6392\u884c\u699c\u6709\u5417\uff1f\u5982\u4f55\u53c2\u8003\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u884c\u4e1a\u5185\u6ca1\u6709\u7edd\u5bf9\u5b98\u65b9\u7684\u7edf\u4e00\u6392\u884c\u699c\uff0c\u4f46\u901a\u5e38\u6839\u636e\u5408\u89c4\u80fd\u529b\u3001\u5e02\u573a\u5360\u6709\u7387\u548c\u7528\u6237\u53e3\u7891\u8fdb\u884c\u5212\u5206\u3002\u9ad8\u5408\u89c4\u9700\u6c42\u573a\u666f\u4e0bHelix ALM\u4e0eJama Connect\u6392\u540d\u9760\u524d\uff1b\u901a\u7528\u654f\u6377\u573a\u666f\u4e0bJira\u4e0eONES\u66f4\u53d7\u9752\u7750\u3002\u5efa\u8bae\u4f01\u4e1a\u4e0d\u8981\u8ff7\u4fe1\u6392\u540d\uff0c\u800c\u5e94\u57fa\u4e8e\u81ea\u8eab\u5408\u89c4\u7b49\u7ea7\u4e0e\u7814\u53d1\u89c4\u6a21\u8fdb\u884c\u9009\u578b\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%B8%BA%E4%BB%80%E4%B9%88%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%E2%80%9C%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%E2%80%9D%EF%BC%9F\"><\/span>\u4e3a\u4ec0\u4e48\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7279\u522b\u5f3a\u8c03\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u201c\u8ffd\u6eaf\u80fd\u529b\u201d\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u56e0\u4e3a\u533b\u7597\u4ea7\u54c1\u76f4\u63a5\u5173\u4e4e\u751f\u547d\u5b89\u5168\uff0c\u6cd5\u89c4\uff08\u5982FDA 21 CFR Part 11\u3001IEC 62304\uff09\u5f3a\u5236\u8981\u6c42\u4f01\u4e1a\u5fc5\u987b\u8bc1\u660e\u4ea7\u54c1\u7684\u6bcf\u4e00\u6b65\u8bbe\u8ba1\u4e0e\u5f00\u53d1\u90fd\u662f\u6709\u636e\u53ef\u67e5\u7684\u3002\u8ffd\u6eaf\u80fd\u529b\u786e\u4fdd\u4efb\u4f55\u4e0a\u7ebf\u7684\u529f\u80fd\u90fd\u80fd\u53cd\u5411\u8ffd\u6eaf\u5230\u539f\u59cb\u9700\u6c42\u4e0e\u6d4b\u8bd5\u7528\u4f8b\uff0c\u662f\u5e94\u5bf9\u76d1\u7ba1\u5ba1\u8ba1\u7684\u6838\u5fc3\u5e95\u7ebf\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E8%83%BD%E5%90%A6%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E7%9A%84%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%EF%BC%9F\"><\/span>Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u884c\u4e1a\u7684\u5408\u89c4\u8981\u6c42\uff1f<span 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