{"id":3179,"date":"2026-06-24T10:20:40","date_gmt":"2026-06-24T02:20:40","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=3179"},"modified":"2026-06-24T10:20:40","modified_gmt":"2026-06-24T02:20:40","slug":"engineering-management-tools-review-guide-94","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools-guides\/engineering-management-tools-review-guide-94","title":{"rendered":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528\uff1f\u4e94\u6b3e\u5de5\u5177\u6df1\u5ea6\u6d4b\u8bc4\u4e0e\u9009\u578b\u6307\u5357"},"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-guides\/engineering-management-tools-review-guide-94\/#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-guides\/engineering-management-tools-review-guide-94\/#%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%E8%BD%AF%E4%BB%B6%E9%80%89%E5%9E%8B%E6%A0%B8%E5%BF%83%E7%BB%B4%E5%BA%A6%E8%A7%A3%E6%9E%90\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u8f6f\u4ef6\u9009\u578b\u6838\u5fc3\u7ef4\u5ea6\u89e3\u6790<\/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-guides\/engineering-management-tools-review-guide-94\/#%E4%BA%94%E6%AC%BE%E4%B8%BB%E6%B5%81%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%E6%A0%B8%E5%BF%83%E7%89%B9%E5%BE%81%E9%80%9F%E8%A7%88\" >\u4e94\u6b3e\u4e3b\u6d41\u7814\u53d1\u7ba1\u7406\u5de5\u5177\u6838\u5fc3\u7279\u5f81\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-guides\/engineering-management-tools-review-guide-94\/#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%E8%BD%AF%E4%BB%B6%E5%93%AA%E5%AE%B6%E6%9C%80%E5%A5%BD%E7%94%A8%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528\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-guides\/engineering-management-tools-review-guide-94\/#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-guides\/engineering-management-tools-review-guide-94\/#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-guides\/engineering-management-tools-review-guide-94\/#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-guides\/engineering-management-tools-review-guide-94\/#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-guides\/engineering-management-tools-review-guide-94\/#Helix_ALM\" >Helix ALM<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/wiz.cn\/blog\/tools-guides\/engineering-management-tools-review-guide-94\/#%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-11\" href=\"https:\/\/wiz.cn\/blog\/tools-guides\/engineering-management-tools-review-guide-94\/#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-12\" href=\"https:\/\/wiz.cn\/blog\/tools-guides\/engineering-management-tools-review-guide-94\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%A0%94%E5%8F%91%E4%B8%BA%E4%BD%95%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E9%9C%80%E6%B1%82%E7%9A%84%E5%8F%8C%E5%90%91%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u4e3a\u4f55\u7279\u522b\u5f3a\u8c03\u9700\u6c42\u7684\u53cc\u5411\u8ffd\u6eaf\u80fd\u529b\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/wiz.cn\/blog\/tools-guides\/engineering-management-tools-review-guide-94\/#%E5%88%9D%E5%88%9B%E5%8C%BB%E7%96%97%E5%9B%A2%E9%98%9F%E5%9C%A8%E9%A2%84%E7%AE%97%E6%9C%89%E9%99%90%E7%9A%84%E6%83%85%E5%86%B5%E4%B8%8B%E5%BA%94%E5%A6%82%E4%BD%95%E9%80%89%E6%8B%A9%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%EF%BC%9F\" >\u521d\u521b\u533b\u7597\u56e2\u961f\u5728\u9884\u7b97\u6709\u9650\u7684\u60c5\u51b5\u4e0b\u5e94\u5982\u4f55\u9009\u62e9\u7814\u53d1\u7ba1\u7406\u5de5\u5177\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-guides\/engineering-management-tools-review-guide-94\/#Helix_ALM%E4%B8%8EJira%E5%9C%A8%E5%8C%BB%E7%96%97%E5%90%88%E8%A7%84%E5%9C%BA%E6%99%AF%E4%B8%8B%E7%9A%84%E4%B8%BB%E8%A6%81%E5%B7%AE%E5%BC%82%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\" >Helix ALM\u4e0eJira\u5728\u533b\u7597\u5408\u89c4\u573a\u666f\u4e0b\u7684\u4e3b\u8981\u5dee\u5f02\u662f\u4ec0\u4e48\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-guides\/engineering-management-tools-review-guide-94\/#Azure_DevOps%E5%A6%82%E4%BD%95%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E7%A0%94%E5%8F%91%E4%B8%AD%E7%9A%84%E6%95%B0%E6%8D%AE%E5%AE%89%E5%85%A8%E4%B8%8E%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%EF%BC%9F\" >Azure DevOps\u5982\u4f55\u6ee1\u8db3\u533b\u7597\u7814\u53d1\u4e2d\u7684\u6570\u636e\u5b89\u5168\u4e0e\u5408\u89c4\u8981\u6c42\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\u533b\u7597\u7814\u53d1\u9762\u4e34\u7740\u524d\u6240\u672a\u6709\u7684\u5408\u89c4\u538b\u529b\u4e0e\u654f\u6377\u4ea4\u4ed8\u9700\u6c42\u3002\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u3001\u6570\u5b57\u7597\u6cd5\u53ca\u533b\u836f\u4fe1\u606f\u5316\u9879\u76ee\u7684\u7814\u53d1\uff0c\u4e0d\u4ec5\u8981\u6c42\u56e2\u961f\u5177\u5907\u9ad8\u6548\u7684\u8fed\u4ee3\u80fd\u529b\uff0c\u66f4\u9700\u4e25\u683c\u6ee1\u8db3FDA\u3001NMPA\u7b49\u76d1\u7ba1\u673a\u6784\u7684\u8ffd\u6eaf\u4e0e\u9a8c\u8bc1\u8981\u6c42\u3002\u9762\u5bf9\u590d\u6742\u7684\u7814\u53d1\u573a\u666f\uff0c\u9009\u62e9\u4e00\u6b3e\u5951\u5408\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u7684\u5de5\u5177\u81f3\u5173\u91cd\u8981\u3002\u672c\u6587\u5c06\u56f4\u7ed5ONES\u3001Tower\u3001Jira\u3001Azure DevOps\u3001Helix ALM\u4e94\u6b3e\u4e3b\u6d41\u5de5\u5177\uff0c\u4e3a\u60a8\u63d0\u4f9b\u6df1\u5ea6\u7684\u9009\u578b\u6307\u5357\u4e0e\u6d4b\u8bc4\u89e3\u6790\uff0c\u52a9\u529b\u4f01\u4e1a\u6784\u5efa\u5408\u89c4\u4e14\u9ad8\u6548\u7684\u7814\u53d1\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%E8%BD%AF%E4%BB%B6%E9%80%89%E5%9E%8B%E6%A0%B8%E5%BF%83%E7%BB%B4%E5%BA%A6%E8%A7%A3%E6%9E%90\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u8f6f\u4ef6\u9009\u578b\u6838\u5fc3\u7ef4\u5ea6\u89e3\u6790<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8bc4\u4f30\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528\u65f6\uff0c\u4e0d\u80fd\u4ec5\u770b\u901a\u7528\u9879\u76ee\u7ba1\u7406\u80fd\u529b\uff0c\u800c\u5e94\u5efa\u7acb\u7b26\u5408\u884c\u4e1a\u7279\u6027\u7684\u8bc4\u6d4b\u6a21\u578b\u3002\u672c\u6b21\u9009\u578b\u4e0e\u6d4b\u8bc4\u4e3b\u8981\u56f4\u7ed5\u4ee5\u4e0b\u56db\u4e2a\u6838\u5fc3\u7ef4\u5ea6\u5c55\u5f00\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bc4\u7ef4\u5ea6<\/th>\n<th>\u8bc4\u4f30\u91cd\u70b9<\/th>\n<th>\u533b\u7597\u884c\u4e1a\u76f8\u5173\u6027<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b<\/td>\n<td>\u9700\u6c42\u53cc\u5411\u8ffd\u6eaf\u3001\u7535\u5b50\u7b7e\u540d\u3001\u5ba1\u8ba1\u65e5\u5fd7\u3001\u7b26\u540821 CFR Part 11\u6807\u51c6<\/td>\n<td>\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u4e0e\u533b\u836f\u7814\u53d1\u4e25\u82db\u7684\u76d1\u7ba1\u5ba1\u67e5\u8981\u6c42<\/td>\n<\/tr>\n<tbody>\n<tr>\n<td>\u654f\u6377\u4e0e\u7011\u5e03\u6df7\u5408\u652f\u6301<\/td>\n<td>\u652f\u6301\u6df7\u5408\u5f0f\u7814\u53d1\u6a21\u578b\u3001\u9636\u6bb5\u95e8\u63a7\u6d41\u7a0b<\/td>\n<td>\u9002\u5e94\u533b\u7597\u4ea7\u54c1\u4ece\u6982\u5ff5\u5230\u4e34\u5e8a\u5ba1\u6279\u7684\u590d\u6742\u6d41\u7a0b<\/td>\n<\/tr>\n<tbody>\n<tr>\n<td>\u5b89\u5168\u4e0e\u6743\u9650\u7ba1\u63a7<\/td>\n<td>\u7ec6\u7c92\u5ea6\u89d2\u8272\u6743\u9650\u3001\u6570\u636e\u52a0\u5bc6\u3001\u79c1\u6709\u5316\u90e8\u7f72\u80fd\u529b<\/td>\n<td>\u4fdd\u969c\u60a3\u8005\u9690\u79c1\u6570\u636e\u53ca\u6838\u5fc3\u7814\u53d1\u8d44\u4ea7\u5b89\u5168<\/td>\n<\/tr>\n<tbody>\n<tr>\n<td>\u751f\u6001\u4e0e\u96c6\u6210\u80fd\u529b<\/td>\n<td>\u5f00\u653eAPI\u3001\u4e0eCI\/CD\u53ca\u6d4b\u8bd5\u5de5\u5177\u7684\u6df1\u5ea6\u96c6\u6210<\/td>\n<td>\u5b9e\u73b0\u4ece\u9700\u6c42\u5230\u90e8\u7f72\u9a8c\u8bc1\u7684\u7aef\u5230\u7aef\u81ea\u52a8\u5316\u95ed\u73af<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%BA%94%E6%AC%BE%E4%B8%BB%E6%B5%81%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%E6%A0%B8%E5%BF%83%E7%89%B9%E5%BE%81%E9%80%9F%E8%A7%88\"><\/span>\u4e94\u6b3e\u4e3b\u6d41\u7814\u53d1\u7ba1\u7406\u5de5\u5177\u6838\u5fc3\u7279\u5f81\u901f\u89c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8fdb\u5165\u6df1\u5ea6\u6d4b\u8bc4\u4e4b\u524d\uff0c\u6211\u4eec\u5148\u5bf9ONES\u3001Tower\u3001Jira\u3001Azure DevOps\u3001Helix ALM\u4e94\u6b3e\u5de5\u5177\u7684\u6838\u5fc3\u5b9a\u4f4d\u4e0e\u533b\u7597\u884c\u4e1a\u9002\u914d\u5ea6\u8fdb\u884c\u6982\u89c8\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u63d0\u4f9b\u7aef\u5230\u7aef\u8ffd\u6eaf\u4e0e\u9ad8\u5ea6\u5b9a\u5236\u5316\u80fd\u529b\uff0c\u5bf9\u533b\u7597\u5408\u89c4\u4e0e\u6df7\u5408\u7814\u53d1\u6a21\u578b\u652f\u6301\u4f18\u5f02\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u8f7b\u91cf\u7ea7\u654f\u6377\u534f\u4f5c\u5de5\u5177\uff0c\u4e0a\u624b\u5feb\uff0c\u9002\u5408\u5c0f\u578b\u533b\u7597\u521b\u65b0\u56e2\u961f\u7684\u57fa\u7840\u4efb\u52a1\u534f\u540c\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u5168\u7403\u5e7f\u6cdb\u5e94\u7528\u7684\u654f\u6377\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0c\u63d2\u4ef6\u751f\u6001\u4e30\u5bcc\uff0c\u901a\u8fc7\u6269\u5c55\u53ef\u6ee1\u8db3\u90e8\u5206\u5408\u89c4\u9700\u6c42\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u4e00\u4f53\u5316DevOps\u5e73\u53f0\uff0c\u4e91\u539f\u751f\u5b89\u5168\u5408\u89c4\u80fd\u529b\u5f3a\uff0c\u9002\u5408\u5927\u578b\u533b\u7597IT\u56e2\u961f\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e3a\u4e25\u82db\u5408\u89c4\u73af\u5883\u8bbe\u8ba1\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u5728\u9700\u6c42\u8ffd\u6eaf\u4e0e\u6d4b\u8bd5\u9a8c\u8bc1\u65b9\u9762\u8868\u73b0\u4e13\u4e1a\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%E8%BD%AF%E4%BB%B6%E5%93%AA%E5%AE%B6%E6%9C%80%E5%A5%BD%E7%94%A8%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\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528\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>\u5de5\u5177\u6982\u51b5\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\u5168\u751f\u547d\u5468\u671f\u7684\u7aef\u5230\u7aef\u7ba1\u7406\u95ed\u73af\u3002\u5176\u5e95\u5c42\u67b6\u6784\u57fa\u4e8e\u9ad8\u5ea6\u53ef\u914d\u7f6e\u7684\u6a21\u578b\u9a71\u52a8\uff0c\u4e0d\u4ec5\u5177\u5907\u5f3a\u5927\u7684\u9700\u6c42\u4e0e\u6d4b\u8bd5\u7ba1\u7406\u57fa\u5ea7\uff0c\u66f4\u901a\u8fc7\u7075\u6d3b\u7684\u6d41\u7a0b\u5f15\u64ce\u4e0e\u81ea\u52a8\u5316\u89c4\u5219\uff0c\u4e3a\u5f3a\u76d1\u7ba1\u3001\u91cd\u5408\u89c4\u7684\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u63d0\u4f9b\u4e86\u4e00\u5957\u517c\u5177\u89c4\u8303\u6027\u4e0e\u654f\u6377\u6027\u7684\u6570\u5b57\u5e95\u5ea7\u3002<\/p>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/p>\n<ul>\n<li>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u94fe\uff1aONES\u652f\u6301\u4ece\u4e34\u5e8a\u9700\u6c42\u3001\u8bbe\u8ba1\u89c4\u8303\u5230\u4ee3\u7801\u63d0\u4ea4\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u7684\u5168\u94fe\u8def\u53cc\u5411\u8ffd\u6eaf\u3002\u5728FDA\u6216NMPA\u5ba1\u8ba1\u573a\u666f\u4e0b\uff0c\u9009\u578b\u4eba\u5458\u53ef\u4e00\u952e\u751f\u6210\u7b26\u5408\u5ba1\u8ba1\u6807\u51c6\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u786e\u4fdd\u6bcf\u9879\u9700\u6c42\u53d8\u66f4\u5747\u6709\u8bb0\u5f55\u95ed\u73af\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u5ba1\u8ba1\u963b\u529b\u3002<\/li>\n<li>\u7cbe\u7ec6\u5316\u8d28\u91cf\u4e0e\u98ce\u9669\u7ba1\u7406\uff1a\u5185\u7f6e\u72ec\u7acb\u4e14\u6df1\u5ea6\u7684\u6d4b\u8bd5\u7ba1\u7406\u6a21\u5757\uff0c\u652f\u6301\u533b\u7597\u8f6f\u4ef6\u7279\u6709\u7684\u9a8c\u8bc1\u4e0e\u786e\u8ba4(V&amp;V)\u6d41\u7a0b\u95ed\u73af\u3002\u7ed3\u5408\u81ea\u5b9a\u4e49\u98ce\u9669\u767b\u8bb0\u8868\u4e0e\u81ea\u52a8\u5316\u7f3a\u9677\u6d41\u8f6c\uff0c\u80fd\u5c06\u98ce\u9669\u63a7\u5236\u524d\u7f6e\u81f3\u7814\u53d1\u65e5\u5e38\uff0c\u5b9e\u73b0\u8d28\u91cf\u95e8\u7981\u7684\u786c\u6027\u7ba1\u63a7\u3002<\/li>\n<li>\u8de8\u804c\u80fd\u4e34\u5e8a\u534f\u540c\u95ed\u73af\uff1a\u9488\u5bf9\u4e34\u5e8a\u4e13\u5bb6\u4e0e\u7814\u53d1\u56e2\u961f\u7684\u8bed\u8a00\u58c1\u5792\uff0cONES\u63d0\u4f9b\u5b9a\u5236\u5316\u89c6\u56fe\u4e0e\u591a\u7ef4\u62a5\u8868\u3002\u4e34\u5e8a\u4e1a\u52a1\u4fa7\u53ef\u901a\u8fc7\u770b\u677f\u8ddf\u8fdb\u60a3\u8005\u5b89\u5168\u76f8\u5173\u7684\u9700\u6c42\u8fdb\u5ea6\uff0c\u7814\u53d1\u4fa7\u5219\u805a\u7126\u8fed\u4ee3\u4ea4\u4ed8\uff0c\u5b9e\u73b0\u4e1a\u52a1\u4e0e\u6280\u672f\u7684\u65e0\u7f1d\u540c\u9891\u3002<\/li>\n<\/ul>\n<p>\u9002\u7528\u573a\u666f\uff1aONES\u5c24\u5176\u9002\u7528\u4e8e\u9700\u517c\u987e\u654f\u6377\u8fed\u4ee3\u4e0e\u5f3a\u5408\u89c4\u8ffd\u6eaf\u7684\u533b\u7597\u8f6f\u4ef6\u7814\u53d1\u7ec4\u7ec7\u3002\u65e0\u8bba\u662f\u533b\u7597\u5668\u68b0\u5d4c\u5165\u5f0f\u8f6f\u4ef6\u5f00\u53d1\u3001\u4e92\u8054\u7f51\u533b\u9662\u5e73\u53f0\u5efa\u8bbe\uff0c\u8fd8\u662f\u533b\u836f\u4f01\u4e1a\u6570\u5b57\u5316\u8f6c\u578b\uff0cONES\u5747\u80fd\u4ee5\u7edf\u4e00\u5e73\u53f0\u6253\u7834\u90e8\u95e8\u58c1\u5792\uff0c\u652f\u6491\u8de8\u804c\u80fd\u56e2\u961f\u5728\u4e25\u683c\u8d28\u91cf\u4f53\u7cfb\u4e0b\u7684\u9ad8\u6548\u4ea4\u4ed8\u3002<\/p>\n<p>\u4f18\u52bf\u4eae\u70b9\uff1aONES\u7684\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5c06\u5408\u89c4\u7ba1\u63a7\u65e0\u7f1d\u878d\u5165\u7814\u53d1\u6d41\uff0c\u800c\u975e\u4e8b\u540e\u8865\u5f55\u3002\u5176\u672c\u5730\u5316\u90e8\u7f72\u4e0e\u6570\u636e\u4e3b\u6743\u4fdd\u969c\u673a\u5236\uff0c\u9ad8\u5ea6\u5951\u5408\u533b\u7597\u884c\u4e1a\u7684\u6570\u636e\u9690\u79c1\u7ea2\u7ebf\u3002\u9009\u578b\u56e2\u961f\u843d\u5730\u65f6\uff0c\u5efa\u8bae\u4f18\u5148\u542f\u7528\u5176\u81ea\u52a8\u5316\u8ffd\u6eaf\u77e9\u9635\u4e0e\u8d28\u91cf\u95e8\u7981\u89c4\u5219\uff0c\u5c06\u5408\u89c4\u5ba1\u8ba1\u6210\u672c\u8f6c\u5316\u4e3a\u7814\u53d1\u6548\u80fd\u7684\u5185\u751f\u9a71\u52a8\u529b\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\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528+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<\/strong>\uff1aTower\u662f\u56fd\u5185\u8f83\u65e9\u63a8\u51fa\u7684\u8f7b\u91cf\u7ea7\u56e2\u961f\u534f\u4f5c\u4e0e\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0c\u4ee5\u754c\u9762\u7b80\u6d01\u3001\u4e0a\u624b\u95e8\u69db\u4f4e\u8457\u79f0\uff0c\u4e3b\u8981\u9762\u5411\u4e92\u8054\u7f51\u53ca\u901a\u7528\u578b\u4e1a\u52a1\u56e2\u961f\u7684\u4efb\u52a1\u534f\u540c\u4e0e\u8fdb\u5ea6\u8ffd\u8e2a\u3002\u5b83\u901a\u8fc7\u770b\u677f\u3001\u5217\u8868\u7b49\u89c6\u56fe\u5b9e\u73b0\u5de5\u4f5c\u6d41\u7684\u53ef\u89c6\u5316\uff0c\u5f3a\u8c03\u654f\u6377\u4e0e\u9ad8\u6548\u6c9f\u901a\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1aTower\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u6df1\u5ea6\u9002\u914d\u80fd\u529b\u76f8\u5bf9\u6709\u9650\uff0c\u5176\u6838\u5fc3\u80fd\u529b\u4e3b\u8981\u4f53\u73b0\u5728\u57fa\u7840\u534f\u4f5c\u5c42\u9762\uff1a<\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u4efb\u52a1\u6d41\u8f6c\u4e0e\u8de8\u804c\u80fd\u534f\u540c<\/strong>\uff1a\u80fd\u652f\u6491\u4e34\u5e8a\u6ce8\u518c\u3001\u5e02\u573a\u4e0e\u7814\u53d1\u90e8\u95e8\u95f4\u7684\u521d\u6b65\u4efb\u52a1\u5206\u53d1\u4e0e\u8fdb\u5ea6\u540c\u6b65\uff0c\u4f46\u7f3a\u4e4f\u9488\u5bf9\u533b\u7597\u7814\u53d1\u7684\u6df1\u5ea6\u72b6\u6001\u673a\u63a7\u5236\u3002<\/li>\n<li><strong>\u6587\u6863\u534f\u540c\u4e0e\u57fa\u7840\u53ef\u8ffd\u6eaf\u6027<\/strong>\uff1a\u652f\u6301\u9879\u76ee\u5185\u6587\u6863\u7684\u5728\u7ebf\u6c89\u6dc0\u4e0e\u7248\u672c\u7ba1\u7406\uff0c\u53ef\u52c9\u5f3a\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u8bbe\u8ba1\u5386\u53f2\u6587\u4ef6\uff08DHF\uff09\u7684\u7c97\u7c92\u5ea6\u5b58\u653e\uff0c\u4f46\u65e0\u6cd5\u63d0\u4f9b\u7b26\u5408FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u8981\u6c42\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u4e25\u683c\u5ba1\u8ba1\u8ffd\u8e2a\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9002\u5408\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u4e2d\u975e\u6838\u5fc3\u7814\u53d1\u7684\u8f7b\u91cf\u7ea7\u4e1a\u52a1\u7ebf\uff0c\u5982\u5065\u5eb7\u7c7bApp\u7684\u654f\u6377\u8fed\u4ee3\u3001\u5e02\u573a\u6d3b\u52a8\u7edf\u7b79\u6216\u5185\u90e8\u884c\u653f\u9879\u76ee\u7ba1\u7406\uff1b\u4e0d\u5efa\u8bae\u7528\u4e8e\u53d7\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\u6216\u521b\u65b0\u836f\u6838\u5fc3\u7814\u53d1\u6d41\u7a0b\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1a\u5b66\u4e60\u6210\u672c\u6781\u4f4e\uff0c\u56e2\u961f\u53ef\u5feb\u901f\u542f\u7528\uff1b\u754c\u9762\u4ea4\u4e92\u4f53\u9a8c\u6d41\u7545\uff1b\u5bf9\u4e8e\u65e0\u9700\u5e94\u5bf9\u4e25\u82db\u5408\u89c4\u5ba1\u8ba1\u7684\u5468\u8fb9\u521b\u65b0\u9879\u76ee\uff0c\u80fd\u4ee5\u8f83\u4f4e\u6210\u672c\u5b9e\u73b0\u56e2\u961f\u5bf9\u9f50\u4e0e\u8fdb\u5ea6\u900f\u660e\u5316\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\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528+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\u5e73\u53f0\uff0cJira\u51ed\u501f\u5176\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684\u5e95\u5c42\u67b6\u6784\u4e0e\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u6784\u5efa\u4e86\u5f3a\u5927\u7684\u9879\u76ee\u8ffd\u8e2a\u5e95\u5ea7\u3002\u7136\u800c\uff0c\u5176\u5f00\u7bb1\u5373\u7528\u4f53\u9a8c\u504f\u91cd\uff0c\u9700\u6295\u5165\u8f83\u9ad8\u7684\u914d\u7f6e\u6210\u672c\u624d\u80fd\u4e0e\u7279\u5b9a\u884c\u4e1a\u7684\u6df1\u5ea6\u5408\u89c4\u8bc9\u6c42\u76f8\u5951\u5408\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\u77e9\u9635\u6784\u5efa\uff1a<\/strong>\u901a\u8fc7\u63d2\u4ef6\u6216\u9ad8\u7ea7\u914d\u7f6e\uff0c\u53ef\u5b9e\u73b0\u4ece\u7528\u6237\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5bf9\u9700\u6c42\u8986\u76d6\u7387\u7684\u4e25\u82db\u5ba1\u8ba1\u8981\u6c42\u3002<\/li>\n<li><strong>\u5408\u89c4\u5de5\u4f5c\u6d41\u5b9a\u5236\uff1a<\/strong>\u652f\u6301\u81ea\u5b9a\u4e49\u72b6\u6001\u673a\u4e0e\u6743\u9650\u6821\u9a8c\uff0c\u53ef\u6a21\u62dfIEC 62304\u7b49\u6cd5\u89c4\u4e2d\u8981\u6c42\u7684\u8bc4\u5ba1\u4e0e\u5ba1\u6279\u95e8\u5f84\uff0c\u786e\u4fdd\u7814\u53d1\u6d41\u7a0b\u5408\u89c4\u3002<\/li>\n<li><strong>\u5ba1\u8ba1\u65e5\u5fd7\u4e0e\u7535\u5b50\u7b7e\u540d\uff1a<\/strong>\u501f\u52a9Jira Assets\u6216\u5408\u89c4\u63d2\u4ef6\uff0c\u53ef\u8bb0\u5f55\u5b57\u6bb5\u7ea7\u53d8\u66f4\u8f68\u8ff9\u5e76\u652f\u6301\u7535\u5b50\u7b7e\u540d\uff0c\u4e3aFDA 21 CFR Part 11\u63d0\u4f9b\u6570\u636e\u652f\u6491\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u62e5\u6709\u4e13\u804cJira\u7ba1\u7406\u5458\u3001\u7814\u53d1\u56e2\u961f\u89c4\u6a21\u8f83\u5927\u4e14\u9700\u5bf9\u63a5\u590d\u6742\u65e2\u6709IT\u7cfb\u7edf\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u3002\u82e5\u56e2\u961f\u7f3a\u4e4f\u5b9a\u5236\u80fd\u529b\u4e14\u9884\u7b97\u6709\u9650\uff0c\u5176\u5408\u89c4\u843d\u5730\u5c06\u6781\u4e3a\u5403\u529b\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u6781\u5176\u7e41\u8363\uff0c\u51e0\u4e4e\u80fd\u901a\u8fc7\u63d2\u4ef6\u586b\u8865\u4efb\u4f55\u80fd\u529b\u7f3a\u53e3\uff1b\u4e0eConfluence\u6df1\u5ea6\u8054\u52a8\uff0c\u4fbf\u4e8e\u6784\u5efa\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u7684\u7814\u53d1\u8d28\u91cf\u6587\u6863\u4f53\u7cfb\uff1b\u5168\u7403\u793e\u533a\u8d44\u6e90\u4e30\u5bcc\uff0c\u95ee\u9898\u6392\u67e5\u6210\u672c\u4f4e\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\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528+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>\u4f5c\u4e3a\u5fae\u8f6f\u65d7\u4e0b\u7684\u4f01\u4e1a\u7ea7DevOps\u5e73\u53f0\uff0cAzure DevOps\u63d0\u4f9b\u4e86\u4ece\u9700\u6c42\u89c4\u5212\u3001\u4ee3\u7801\u7ba1\u7406\u3001CI\/CD\u5230\u6d4b\u8bd5\u76d1\u63a7\u7684\u5168\u94fe\u8def\u5de5\u5177\u94fe\u3002\u5176\u5e95\u5c42\u67b6\u6784\u6210\u719f\u3001\u751f\u6001\u6269\u5c55\u6027\u6781\u5f3a\uff0c\u662f\u5927\u578b\u5168\u7403\u5316\u7814\u53d1\u56e2\u961f\u8fdb\u884c\u590d\u6742\u5de5\u7a0b\u7ba1\u7406\u7684\u5e95\u5c42\u57fa\u7840\u8bbe\u65bd\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>\u6df1\u5ea6\u96c6\u6210Azure Active Directory\u4e0e\u9ad8\u7ea7\u5b89\u5168\u7b56\u7565\uff0c\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u6743\u9650\u9694\u79bb\u4e0e\u64cd\u4f5c\u5ba1\u8ba1\u65e5\u5fd7\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u533b\u7597\u6cd5\u89c4\u5bf9\u7535\u5b50\u7b7e\u540d\u4e0e\u6570\u636e\u5b8c\u6574\u6027\u7684\u4e25\u82db\u8ffd\u6eaf\u8981\u6c42\u3002<\/li>\n<li><strong>\u9ad8\u5bc6\u6570\u636e\u5b89\u5168\u7ba1\u63a7\uff1a<\/strong>\u4f9d\u6258\u5fae\u8f6f\u5168\u7403\u5408\u89c4\u8ba4\u8bc1\u4f53\u7cfb\uff0c\u652f\u6301\u654f\u611f\u533b\u7597\u6570\u636e\u5728\u4e91\u7aef\u6216\u672c\u5730Azure\u7684\u9694\u79bb\u90e8\u7f72\uff0c\u786e\u4fdd\u60a3\u8005\u9690\u79c1\u4e0e\u6838\u5fc3\u7814\u53d1\u8d44\u4ea7\u7684\u5b89\u5168\u8fb9\u754c\u3002<\/li>\n<li><strong>\u81ea\u52a8\u5316\u8d28\u91cf\u95e8\u7981\uff1a<\/strong>\u901a\u8fc7Azure Pipelines\u4e0e\u6d4b\u8bd5\u8ba1\u5212\u8054\u52a8\uff0c\u53ef\u5f3a\u5236\u8bbe\u5b9a\u4ee3\u7801\u5ba1\u67e5\u3001\u9759\u6001\u5b89\u5168\u626b\u63cf\u4e0e\u81ea\u52a8\u5316\u6d4b\u8bd5\u7684\u901a\u8fc7\u9608\u503c\uff0c\u786e\u4fdd\u533b\u7597\u8f6f\u4ef6\u4ea4\u4ed8\u7b26\u5408IEC 62304\u7b49\u9ad8\u53ef\u9760\u6027\u6807\u51c6\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5177\u5907\u4e00\u5b9a\u7814\u53d1\u89c4\u6a21\u3001\u6280\u672f\u6808\u4ee5\u5fae\u8f6f\u751f\u6001\u4e3a\u4e3b\uff0c\u4e14\u5bf9\u6570\u636e\u5b89\u5168\u5408\u89c4\u4e0eCI\/CD\u81ea\u52a8\u5316\u6709\u521a\u6027\u9700\u6c42\u7684\u5927\u578b\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u6216\u6570\u5b57\u7597\u6cd5\u7814\u53d1\u56e2\u961f\u3002\u5bf9\u4e8e\u8f7b\u91cf\u7ea7\u6216\u521d\u521b\u533b\u7597\u56e2\u961f\u800c\u8a00\uff0c\u5176\u914d\u7f6e\u4e0e\u5b66\u4e60\u6210\u672c\u504f\u9ad8\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u58c1\u5792\u9ad8\uff0c\u4e0eGitHub\u3001Visual Studio\u7b49\u65e0\u7f1d\u8854\u63a5\uff1b\u4f01\u4e1a\u7ea7\u6743\u9650\u4e0e\u5b89\u5168\u7ba1\u63a7\u6781\u4e3a\u7cbe\u7ec6\uff1bPipeline\u7684\u5e76\u53d1\u4e0e\u8de8\u5e73\u53f0\u90e8\u7f72\u80fd\u529b\u5f3a\u5927\uff0c\u80fd\u6709\u6548\u652f\u6491\u533b\u7597\u8f6f\u4ef6\u9ad8\u9891\u6b21\u3001\u9ad8\u5408\u89c4\u7684\u6301\u7eed\u4ea4\u4ed8\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\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528+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>\u5de5\u5177\u6982\u51b5\uff1aHelix ALM \u662f\u4e00\u6b3e\u4e13\u4e3a\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u8bbe\u8ba1\u7684\u7aef\u5230\u7aef\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5e73\u53f0\u3002\u5b83\u5c06\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u7ba1\u7406\u4e0e\u7f3a\u9677\u8ffd\u8e2a\u6df1\u5ea6\u6574\u5408\u4e8e\u5355\u4e00\u67b6\u6784\u4e2d\uff0c\u5728\u533b\u7597\u8bbe\u5907\u4e0e\u751f\u547d\u79d1\u5b66\u9886\u57df\u6df1\u8015\u591a\u5e74\uff0c\u5176\u5e95\u5c42\u903b\u8f91\u5b8c\u5168\u5951\u5408FDA 21 CFR Part 11\u7b49\u4e25\u82db\u6cd5\u89c4\u7684\u76d1\u7ba1\u9884\u671f\uff0c\u662f\u4f20\u7edf\u91cd\u578b\u5408\u89c4\u9879\u76ee\u7684\u7ecf\u5178\u9009\u578b\u3002<\/p>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/p>\n<ul>\n<li>\u5168\u94fe\u8def\u53ef\u8ffd\u6eaf\u6027\u4e0e\u5408\u89c4\u57fa\u7ebf\uff1a\u63d0\u4f9b\u4ece\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u518d\u5230\u7f3a\u9677\u7684\u53cc\u5411\u8ffd\u6eaf\u77e9\u9635\uff0c\u652f\u6301\u5e26\u7535\u5b50\u7b7e\u540d\u7684\u57fa\u7ebf\u51bb\u7ed3\uff0c\u76f4\u63a5\u54cd\u5e94FDA\u5ba1\u8ba1\u5bf9\u53d8\u66f4\u5386\u53f2\u4e0d\u53ef\u7be1\u6539\u6027\u7684\u786c\u6027\u8981\u6c42\u3002<\/li>\n<li>\u5185\u7f6e\u9a8c\u8bc1\u4e0e\u786e\u8ba4(V&amp;V)\u95ed\u73af\uff1a\u539f\u751f\u652f\u6301IQ\/OQ\/PQ\u9a8c\u8bc1\u534f\u8bae\u6a21\u677f\u4e0e\u6267\u884c\u8bb0\u5f55\uff0c\u5c06\u533b\u7597\u884c\u4e1a\u5f3a\u5236\u6027\u7684\u7cfb\u7edf\u9a8c\u8bc1\u6d41\u7a0b\u5185\u5316\u4e8e\u5de5\u5177\u94fe\u4e2d\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u4ea4\u4ed8\u7684\u6587\u6863\u6210\u672c\u3002<\/li>\n<li>\u7cbe\u7ec6\u5316\u6743\u9650\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a\u5177\u5907\u9897\u7c92\u5ea6\u6781\u7ec6\u7684\u89d2\u8272\u6743\u9650\u63a7\u5236\u4e0e\u5b8c\u6574\u7684\u64cd\u4f5c\u5ba1\u8ba1\u65e5\u5fd7\uff0c\u786e\u4fdd\u654f\u611f\u7814\u53d1\u6570\u636e\u8bbf\u95ee\u7684\u5408\u6cd5\u6027\u4e0e\u53ef\u8ffd\u6eaf\u6027\uff0c\u6ee1\u8db3HIPAA\u5bf9\u6570\u636e\u9690\u79c1\u4e0e\u5b89\u5168\u7684\u7ba1\u63a7\u6807\u51c6\u3002<\/li>\n<\/ul>\n<p>\u9002\u7528\u573a\u666f\uff1a\u9ad8\u5ea6\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u5d4c\u5165\u5f0f\u8f6f\u4ef6\u7814\u53d1\u3001\u4f53\u5916\u8bca\u65ad(IVD)\u8bbe\u5907\u7cfb\u7edf\u5f00\u53d1\uff0c\u4ee5\u53ca\u4efb\u4f55\u5fc5\u987b\u901a\u8fc7FDA\u3001CE IEC 62304\u8ba4\u8bc1\u4e14\u5bf9\u5ba1\u8ba1\u8ffd\u8e2a\u6709\u96f6\u5bb9\u5fcd\u98ce\u9669\u7684\u751f\u547d\u79d1\u5b66\u9879\u76ee\u3002<\/p>\n<p>\u4f18\u52bf\u4eae\u70b9\uff1a\u5176\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u201c\u5408\u89c4\u5373\u9ed8\u8ba4\u201d\u2014\u2014\u7cfb\u7edf\u5f00\u7bb1\u5373\u7528\u5373\u5bfc\u5411\u5408\u89c4\uff0c\u65e0\u9700\u50cf\u901a\u7528\u5de5\u5177\u90a3\u6837\u901a\u8fc7\u7e41\u6742\u914d\u7f6e\u53bb\u62fc\u51d1\u5408\u89c4\u8bc1\u636e\u94fe\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u4ea4\u4e92\u903b\u8f91\u504f\u5411\u4f20\u7edf\u5de5\u7a0b\u8f6f\u4ef6\uff0c\u5b66\u4e60\u66f2\u7ebf\u9661\u5ced\uff0c\u4e14\u90e8\u7f72\u4e0e\u7ef4\u62a4\u6210\u672c\u8f83\u9ad8\uff0c\u66f4\u9002\u5408\u9884\u7b97\u5145\u8db3\u4e14\u5408\u89c4\u538b\u529b\u5904\u4e8e\u6700\u9ad8\u4f18\u5148\u7ea7\u7684\u6210\u719f\u533b\u7597\u7814\u53d1\u7ec4\u7ec7\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\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528+Helix ALM \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>\u7efc\u5408\u4ee5\u4e0a\u5206\u6790\uff0c\u9488\u5bf9\u201c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u8f6f\u4ef6\u54ea\u5bb6\u6700\u597d\u7528\u201d\u8fd9\u4e00\u95ee\u9898\uff0c\u5e76\u65e0\u7edd\u5bf9\u7b54\u6848\uff0c\u5173\u952e\u5728\u4e8e\u4f01\u4e1a\u89c4\u6a21\u4e0e\u5408\u89c4\u6df1\u5ea6\u7684\u5339\u914d\uff1a<\/p>\n<ol>\n<li>\u5bf9\u4e8e<strong>\u5f3a\u5408\u89c4\u3001\u91cd\u8ffd\u6eaf<\/strong>\u7684\u4f20\u7edf\u533b\u7597\u5668\u68b0\u4e0e\u533b\u836f\u7814\u53d1\u4f01\u4e1a\uff0c<strong>Helix ALM<\/strong>\u662f\u4e13\u4e1a\u4e4b\u9009\uff0c<strong>ONES<\/strong>\u5219\u63d0\u4f9b\u4e86\u66f4\u73b0\u4ee3\u5316\u7684\u5168\u573a\u666f\u7ba1\u7406\u65b9\u6848\u3002<\/li>\n<li>\u5bf9\u4e8e<strong>\u5927\u578b\u533b\u7597\u4fe1\u606f\u5316\u56e2\u961f<\/strong>\u4e14\u6df1\u5ea6\u7ed1\u5b9a\u5fae\u8f6f\u6280\u672f\u6808\u7684\u4f01\u4e1a\uff0c<strong>Azure DevOps<\/strong>\u80fd\u63d0\u4f9b\u5f00\u7bb1\u5373\u7528\u7684\u5b89\u5168\u4e0eDevOps\u95ed\u73af\u3002<\/li>\n<li>\u5bf9\u4e8e<strong>\u5df2\u6709Atlassian\u751f\u6001\u57fa\u7840<\/strong>\u7684\u56e2\u961f\uff0c<strong>Jira<\/strong>\u914d\u5408\u5408\u89c4\u63d2\u4ef6\u53ef\u6ee1\u8db3\u4e2d\u7b49\u5408\u89c4\u8981\u6c42\u3002<\/li>\n<li>\u5bf9\u4e8e<strong>\u521d\u521b\u578b\u6570\u5b57\u5065\u5eb7\u56e2\u961f<\/strong>\uff0c\u82e5\u6682\u65e0\u4e25\u82db\u5408\u89c4\u538b\u529b\uff0c<strong>Tower<\/strong>\u53ef\u4f5c\u4e3a\u5feb\u901f\u8d77\u6b65\u7684\u8f7b\u91cf\u7ea7\u5de5\u5177\u3002<\/li>\n<\/ol>\n<p>2026\u5e74\uff0c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u7814\u53d1\u7ba1\u7406\u6b63\u8d70\u5411\u6df1\u5ea6\u5408\u89c4\u4e0e\u9ad8\u6548\u4ea4\u4ed8\u7684\u53cc\u8f68\u5e76\u884c\u3002\u5efa\u8bae\u4f01\u4e1a\u5728\u9009\u578b\u65f6\u660e\u786e\u81ea\u8eab\u7684\u5408\u89c4\u57fa\u7ebf\u4e0e\u7814\u53d1\u89c4\u6a21\uff0c\u4f18\u5148\u652f\u6301\u5168\u94fe\u8def\u8ffd\u6eaf\u4e0e\u6df7\u5408\u6a21\u578b\u7684\u5e73\u53f0\uff0c\u65b9\u80fd\u5728\u76d1\u7ba1\u8d8b\u4e25\u7684\u7ade\u4e89\u4e2d\u7a33\u6b65\u524d\u884c\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%E4%B8%BA%E4%BD%95%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E9%9C%80%E6%B1%82%E7%9A%84%E5%8F%8C%E5%90%91%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u4e3a\u4f55\u7279\u522b\u5f3a\u8c03\u9700\u6c42\u7684\u53cc\u5411\u8ffd\u6eaf\u80fd\u529b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u533b\u7597\u884c\u4e1a\u53d7FDA\u3001NMPA\u7b49\u4e25\u683c\u76d1\u7ba1\uff0c\u8981\u6c42\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u3001\u8bbe\u8ba1\u5b9e\u73b0\u5230\u6d4b\u8bd5\u9a8c\u8bc1\u5fc5\u987b\u5177\u5907\u5b8c\u6574\u7684\u53cc\u5411\u8ffd\u6eaf\u94fe\u8def\u3002\u8fd9\u786e\u4fdd\u4e86\u4efb\u4f55\u9700\u6c42\u53d8\u66f4\u90fd\u80fd\u88ab\u8bc4\u4f30\u5f71\u54cd\uff0c\u4e14\u6240\u6709\u529f\u80fd\u5747\u88ab\u5145\u5206\u9a8c\u8bc1\uff0c\u662f\u901a\u8fc7\u5408\u89c4\u5ba1\u8ba1\u7684\u786c\u6027\u8981\u6c42\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E5%88%9D%E5%88%9B%E5%8C%BB%E7%96%97%E5%9B%A2%E9%98%9F%E5%9C%A8%E9%A2%84%E7%AE%97%E6%9C%89%E9%99%90%E7%9A%84%E6%83%85%E5%86%B5%E4%B8%8B%E5%BA%94%E5%A6%82%E4%BD%95%E9%80%89%E6%8B%A9%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%EF%BC%9F\"><\/span>\u521d\u521b\u533b\u7597\u56e2\u961f\u5728\u9884\u7b97\u6709\u9650\u7684\u60c5\u51b5\u4e0b\u5e94\u5982\u4f55\u9009\u62e9\u7814\u53d1\u7ba1\u7406\u5de5\u5177\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u82e5\u5904\u4e8e\u65e9\u671f\u63a2\u7d22\u9636\u6bb5\u4e14\u6682\u65e0\u4e25\u82db\u7684\u533b\u7597\u5668\u68b0\u5408\u89c4\u5ba1\u8ba1\u538b\u529b\uff0c\u53ef\u4f18\u5148\u9009\u62e9Tower\u7b49\u8f7b\u91cf\u7ea7\u5de5\u5177\u5b9e\u73b0\u654f\u6377\u534f\u540c\uff1b\u82e5\u7814\u53d1\u6d89\u53caSaMD\u4e14\u672a\u6765\u6709\u5408\u89c4\u89c4\u5212\uff0c\u5efa\u8bae\u76f4\u63a5\u91c7\u7528ONES\u6216Jira\u7b49\u5177\u5907\u6269\u5c55\u6027\u548c\u57fa\u7840\u8ffd\u6eaf\u80fd\u529b\u7684\u5e73\u53f0\uff0c\u907f\u514d\u540e\u671f\u8fc1\u79fb\u6210\u672c\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_ALM%E4%B8%8EJira%E5%9C%A8%E5%8C%BB%E7%96%97%E5%90%88%E8%A7%84%E5%9C%BA%E6%99%AF%E4%B8%8B%E7%9A%84%E4%B8%BB%E8%A6%81%E5%B7%AE%E5%BC%82%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\"><\/span>Helix ALM\u4e0eJira\u5728\u533b\u7597\u5408\u89c4\u573a\u666f\u4e0b\u7684\u4e3b\u8981\u5dee\u5f02\u662f\u4ec0\u4e48\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Helix ALM\u662f\u4e13\u4e3a\u9ad8\u5408\u89c4\u884c\u4e1a\u8bbe\u8ba1\u7684\u5f00\u7bb1\u5373\u7528\u65b9\u6848\uff0c\u5185\u7f6e\u7535\u5b50\u7b7e\u540d\u3001\u9700\u6c42\u53cc\u5411\u8ffd\u6eaf\u53ca\u7b26\u540821 CFR Part 11\u7684\u9a8c\u8bc1\u6587\u6863\uff1b\u800cJira\u672c\u8eab\u662f\u654f\u6377\u7ba1\u7406\u5de5\u5177\uff0c\u9700\u4f9d\u8d56Marketplace\u4e0a\u7684\u7b2c\u4e09\u65b9\u63d2\u4ef6\uff08\u5982Xray\u3001Zephyr\u7b49\uff09\u6765\u62fc\u51d1\u5408\u89c4\u80fd\u529b\uff0c\u7cfb\u7edf\u6574\u5408\u4e0e\u9a8c\u8bc1\u6210\u672c\u8f83\u9ad8\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Azure_DevOps%E5%A6%82%E4%BD%95%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E7%A0%94%E5%8F%91%E4%B8%AD%E7%9A%84%E6%95%B0%E6%8D%AE%E5%AE%89%E5%85%A8%E4%B8%8E%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%EF%BC%9F\"><\/span>Azure DevOps\u5982\u4f55\u6ee1\u8db3\u533b\u7597\u7814\u53d1\u4e2d\u7684\u6570\u636e\u5b89\u5168\u4e0e\u5408\u89c4\u8981\u6c42\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Azure DevOps\u4f9d\u6258\u5fae\u8f6fAzure\u4e91\u57fa\u7840\u8bbe\u65bd\uff0c\u63d0\u4f9b\u4f01\u4e1a\u7ea7\u7684\u6570\u636e\u52a0\u5bc6\u3001\u7ec6\u7c92\u5ea6\u8bbf\u95ee\u63a7\u5236\u53ca\u7b26\u5408ISO 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