{"id":1069,"date":"2026-06-06T18:19:18","date_gmt":"2026-06-06T10:19:18","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=1069"},"modified":"2026-06-06T18:19:18","modified_gmt":"2026-06-06T10:19:18","slug":"engineering-management-tools-review-guide-21","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-guide-21","title":{"rendered":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u63a8\u8350\u54ea\u6b3e\u9760\u8c31\uff1f\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\/engineering-management-tools-review-guide-21\/#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-guide-21\/#%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%E9%80%89%E5%9E%8B%E6%96%B9%E6%B3%95%E4%B8%8E%E6%A0%B8%E5%BF%83%E6%B5%8B%E8%AF%84%E7%BB%B4%E5%BA%A6\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u9009\u578b\u65b9\u6cd5\u4e0e\u6838\u5fc3\u6d4b\u8bc4\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-guide-21\/#%E4%B8%BB%E6%B5%81%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%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\" >\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\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\/engineering-management-tools-review-guide-21\/#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%A8%E8%8D%90%E5%93%AA%E6%AC%BE%E9%9D%A0%E8%B0%B1%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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31\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-guide-21\/#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-guide-21\/#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-guide-21\/#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-guide-21\/#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-guide-21\/#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-guide-21\/#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-guide-21\/#%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%80%BB%E7%BB%93%EF%BC%9A%E5%A6%82%E4%BD%95%E9%94%9A%E5%AE%9A%E6%9C%80%E9%80%82%E5%90%88%E7%9A%84%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F\" >\u9009\u578b\u5efa\u8bae\u4e0e\u603b\u7ed3\uff1a\u5982\u4f55\u951a\u5b9a\u6700\u9002\u5408\u7684\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf<\/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-guide-21\/#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-guide-21\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E4%B8%BA%E4%BB%80%E4%B9%88%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%E9%9C%80%E6%B1%82%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u7279\u522b\u5f3a\u8c03\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u9700\u6c42\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-14\" href=\"https:\/\/wiz.cn\/blog\/tools\/engineering-management-tools-review-guide-21\/#Jira%E8%83%BD%E5%90%A6%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%9A%84%E5%90%88%E8%A7%84%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E9%9C%80%E6%B1%82%EF%BC%9F\" >Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5408\u89c4\u7814\u53d1\u7ba1\u7406\u9700\u6c42\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-guide-21\/#%E5%88%9D%E5%88%9B%E5%9E%8B%E6%95%B0%E5%AD%97%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%E8%AF%A5%E5%A6%82%E4%BD%95%E9%80%89%E5%9E%8B%EF%BC%9F\" >\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\u5728\u9884\u7b97\u6709\u9650\u7684\u60c5\u51b5\u4e0b\u8be5\u5982\u4f55\u9009\u578b\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-guide-21\/#Azure_DevOps%E5%9C%A8%E5%8C%BB%E7%96%97%E7%A0%94%E5%8F%91%E4%B8%AD%E7%9A%84%E6%A0%B8%E5%BF%83%E4%BC%98%E5%8A%BF%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\" >Azure DevOps\u5728\u533b\u7597\u7814\u53d1\u4e2d\u7684\u6838\u5fc3\u4f18\u52bf\u662f\u4ec0\u4e48\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\u77402026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u6570\u5b57\u5316\u8f6c\u578b\u7684\u6301\u7eed\u6df1\u5316\uff0c\u7814\u53d1\u73af\u8282\u6240\u9762\u4e34\u7684\u5408\u89c4\u538b\u529b\u4e0e\u534f\u540c\u590d\u6742\u5ea6\u8fbe\u5230\u4e86\u524d\u6240\u672a\u6709\u7684\u9ad8\u5ea6\u3002\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u3001\u6570\u5b57\u7597\u6cd5\u53ca\u521b\u65b0\u836f\u7814\u9879\u76ee\u4e0d\u4ec5\u9700\u8981\u654f\u6377\u7684\u8fed\u4ee3\u901f\u5ea6\uff0c\u66f4\u5fc5\u987b\u4e25\u683c\u9075\u5faaFDA 21 CFR Part 11\u3001ISO 13485\u53caIEC 62304\u7b49\u884c\u4e1a\u6cd5\u89c4\u3002\u9762\u5bf9\u6d77\u91cf\u7684\u9700\u6c42\u8ffd\u6eaf\u4e0e\u8d28\u91cf\u5ba1\u8ba1\u8981\u6c42\uff0c\u4f20\u7edf\u7684\u7ba1\u7406\u65b9\u5f0f\u5df2\u96be\u4ee5\u4e3a\u7ee7\u3002\u5bfb\u627e\u4e00\u6b3e\u771f\u6b63\u5951\u5408\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u7684\u7cfb\u7edf\uff0c\u6210\u4e3a\u4f01\u4e1a\u964d\u4f4e\u5408\u89c4\u98ce\u9669\u3001\u63d0\u5347\u4ea4\u4ed8\u6548\u7387\u7684\u5173\u952e\u7834\u5c40\u70b9\u3002\u672c\u6587\u5c06\u4e3a\u60a8\u7cfb\u7edf\u68b3\u7406\u9009\u578b\u903b\u8f91\uff0c\u5e76\u6df1\u5ea6\u5256\u6790\u4e3b\u6d41\u5de5\u5177\uff0c\u89e3\u7b54\u201c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u63a8\u8350\u54ea\u6b3e\u9760\u8c31\u201d\u8fd9\u4e00\u6838\u5fc3\u547d\u9898\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%E9%80%89%E5%9E%8B%E6%96%B9%E6%B3%95%E4%B8%8E%E6%A0%B8%E5%BF%83%E6%B5%8B%E8%AF%84%E7%BB%B4%E5%BA%A6\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u9009\u578b\u65b9\u6cd5\u4e0e\u6838\u5fc3\u6d4b\u8bc4\u7ef4\u5ea6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8bc4\u4f30\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u65f6\uff0c\u4e0d\u80fd\u4ec5\u505c\u7559\u5728\u57fa\u7840\u7684\u9879\u76ee\u7ba1\u7406\u529f\u80fd\u5c42\u9762\uff0c\u800c\u5e94\u5efa\u7acb\u4ee5\u201c\u5408\u89c4\u4e0e\u8ffd\u6eaf\u201d\u4e3a\u6838\u5fc3\u7684\u6d4b\u8bc4\u6a21\u578b\u3002\u9009\u578b\u56e2\u961f\u5e94\u4ece\u4ee5\u4e0b\u56db\u5927\u7ef4\u5ea6\u8fdb\u884c\u7efc\u5408\u8003\u91cf\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bc4\u7ef4\u5ea6<\/th>\n<th>\u5173\u952e\u8003\u5bdf\u70b9<\/th>\n<th>\u533b\u7597\u884c\u4e1a\u7279\u5b9a\u8981\u6c42<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b<\/td>\n<td>\u7aef\u5230\u7aef\u9700\u6c42\u8ffd\u6eaf\u3001\u7535\u5b50\u7b7e\u540d\u3001\u5ba1\u8ba1\u8ffd\u8e2a<\/td>\n<td>\u5fc5\u987b\u6ee1\u8db3ISO 62304\u53ca21 CFR Part 11\u5408\u89c4\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u654f\u6377\u4e0e\u7011\u5e03\u6df7\u5408\u652f\u6301<\/td>\n<td>\u5de5\u4f5c\u6d41\u81ea\u5b9a\u4e49\u3001\u591a\u8303\u5f0f\u9879\u76ee\u6a21\u578b\u652f\u6301<\/td>\n<td>\u9002\u5e94\u533b\u7597\u4ea7\u54c1\u4ece\u6982\u5ff5\u9a8c\u8bc1\u5230\u4e34\u5e8a\u5ba1\u6279\u7684\u6df7\u5408\u7ba1\u7406\u6a21\u5f0f<\/td>\n<\/tr>\n<tr>\n<td>\u8d28\u91cf\u4e0e\u98ce\u9669\u7ba1\u7406<\/td>\n<td>CAPA\u7ba1\u7406\u3001FMEA\u96c6\u6210\u3001\u7f3a\u9677\u5173\u8054\u98ce\u9669\u9879<\/td>\n<td>\u5b9e\u73b0\u7814\u53d1\u8fc7\u7a0b\u4e0e\u8d28\u91cf\u4f53\u7cfb\u7684\u53cc\u5411\u8054\u52a8<\/td>\n<\/tr>\n<tr>\n<td>\u751f\u6001\u4e0e\u96c6\u6210\u80fd\u529b<\/td>\n<td>\u5f00\u653eAPI\u3001\u7b2c\u4e09\u65b9\u5f00\u53d1\u5de5\u5177\u4e0e\u6d4b\u8bd5\u5de5\u5177\u5bf9\u63a5<\/td>\n<td>\u9700\u65e0\u7f1d\u5bf9\u63a5Jenkins\u3001GitLab\u53ca\u4e13\u4e1a\u533b\u7597\u6d4b\u8bd5\u8f6f\u4ef6<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%BB%E6%B5%81%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%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>\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\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\u5bf9\u5e02\u9762\u4e0a\u5907\u53d7\u5173\u6ce8\u76846\u6b3e\u7814\u53d1\u7ba1\u7406\u5de5\u5177\u8fdb\u884c\u6838\u5fc3\u7279\u5f81\u901f\u89c8\uff0c\u5e2e\u52a9\u60a8\u5feb\u901f\u5efa\u7acb\u6574\u4f53\u8ba4\u77e5\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u63d0\u4f9b\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u5e95\u5ea7\uff0c\u5177\u5907\u5f3a\u5927\u7684\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\u4e0e\u5168\u5c40\u8ffd\u6eaf\u80fd\u529b\uff0c\u9002\u5408\u9700\u8981\u7075\u6d3b\u642d\u5efa\u5408\u89c4\u4f53\u7cfb\u7684\u672c\u571f\u533b\u7597\u56e2\u961f\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u4ee5\u8f7b\u91cf\u7ea7\u534f\u540c\u89c1\u957f\uff0c\u754c\u9762\u76f4\u89c2\u6613\u7528\uff0c\u9002\u5408\u521d\u521b\u578b\u6570\u5b57\u5065\u5eb7\u56e2\u961f\u7684\u57fa\u7840\u7814\u53d1\u534f\u4f5c\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\u63d2\u4ef6\u751f\u6001\u6781\u5176\u4e30\u5bcc\uff0c\u53ef\u901a\u8fc7\u6269\u5c55\u5b9e\u73b0\u533b\u7597\u5408\u89c4\uff0c\u4f46\u914d\u7f6e\u6210\u672c\u4e0e\u7ef4\u62a4\u95e8\u69db\u8f83\u9ad8\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u4e0b\u7684\u5168\u80fd\u9009\u624b\uff0c\u63d0\u4f9b\u4ece\u4ee3\u7801\u5230\u90e8\u7f72\u7684\u5b8c\u6574DevOps\u94fe\u8def\uff0c\u9002\u5408\u5927\u578b\u533b\u7597IT\u56e2\u961f\u6784\u5efa\u4e91\u539f\u751f\u5408\u89c4\u6d41\u6c34\u7ebf\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e3a\u4e25\u82db\u5408\u89c4\u73af\u5883\u8bbe\u8ba1\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u5185\u7f6e\u5f3a\u5927\u7684\u9700\u6c42\u4e0e\u6d4b\u8bd5\u8ffd\u6eaf\u77e9\u9635\uff0c\u662f\u4f20\u7edf\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\u7684\u5408\u89c4\u5229\u5668\u3002<\/li>\n<li><strong>Jama Connect<\/strong>\uff1a\u805a\u7126\u4e8e\u590d\u6742\u4ea7\u54c1\u7814\u53d1\u7684\u9700\u6c42\u7ba1\u7406\u4e0e\u98ce\u9669\u5206\u6790\uff0c\u5176\u884c\u4e1a\u9886\u5148\u7684Live Traceability\u2122\u6280\u672f\uff0c\u4e3a\u533b\u7597\u5408\u89c4\u5ba1\u8ba1\u63d0\u4f9b\u5f3a\u6709\u529b\u7684\u652f\u6491\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%A8%E8%8D%90%E5%93%AA%E6%AC%BE%E9%9D%A0%E8%B0%B1%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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31\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\u4f01\u7ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u57282026\u5e74\u5df2\u6f14\u8fdb\u4e3a\u8986\u76d6\u9879\u76ee\u5168\u751f\u547d\u5468\u671f\u7684\u6570\u5b57\u5316\u67a2\u7ebd\u3002\u5176\u4ee5\u300c\u7edf\u4e00\u5e95\u5ea7+\u7075\u6d3b\u7ec4\u88c5\u300d\u7684\u67b6\u6784\u8bbe\u8ba1\uff0c\u6253\u7834\u4e86\u4f20\u7edf\u5de5\u5177\u7684\u6570\u636e\u5b64\u5c9b\uff0c\u4e3a\u533b\u7597\u5065\u5eb7\u8fd9\u7c7b\u5f3a\u76d1\u7ba1\u3001\u957f\u5468\u671f\u3001\u591a\u8de8\u57df\u7684\u884c\u4e1a\uff0c\u63d0\u4f9b\u4e86\u4e00\u5957\u4ece\u9700\u6c42\u89c4\u5212\u5230\u4ea4\u4ed8\u8ffd\u8e2a\u7684\u7aef\u5230\u7aef\u89e3\u51b3\u65b9\u6848\uff0c\u662f\u5f53\u524d\u63a2\u5bfb\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u63a8\u8350\u54ea\u6b3e\u9760\u8c31\u65f6\u7684\u6838\u5fc3\u5019\u9009\u8005\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>\u5f3a\u5408\u89c4\u4e0e\u5168\u94fe\u8def\u8ffd\u6eaf\uff1aONES\u5185\u7f6e\u7684\u8ffd\u8e2a\u77e9\u9635\u80fd\u529b\uff0c\u80fd\u5c06\u533b\u7597\u8f6f\u4ef6\u7684\u6cd5\u89c4\u9700\u6c42\uff08\u5982FDA\u3001NMPA\u5408\u89c4\u6307\u5357\uff09\u5411\u4e0b\u62c6\u89e3\u81f3\u4ee3\u7801\u63d0\u4ea4\u4e0e\u6d4b\u8bd5\u7528\u4f8b\uff0c\u5b9e\u73b0\u9700\u6c42-\u8bbe\u8ba1-\u5f00\u53d1-\u9a8c\u8bc1\u7684\u53cc\u5411\u95ed\u73af\uff0c\u4e3a\u5ba1\u8ba1\u63d0\u4f9b\u4e0d\u53ef\u7be1\u6539\u7684\u6570\u5b57\u8bc1\u636e\u94fe\u3002<\/li>\n<li>\u590d\u6742\u591a\u89d2\u8272\u534f\u540c\u4e0e\u6743\u9650\u9694\u79bb\uff1a\u533b\u7597\u7814\u53d1\u6d89\u53ca\u4e34\u5e8a\u4e13\u5bb6\u3001\u6cd5\u89c4\u6ce8\u518c\u3001\u8f6f\u786c\u4ef6\u5de5\u7a0b\u5e08\u7b49\u3002ONES\u63d0\u4f9b\u7cbe\u7ec6\u5316\u89d2\u8272\u6743\u9650\u77e9\u9635\u4e0e\u5de5\u4f5c\u6d41\u7f16\u6392\uff0c\u786e\u4fdd\u5404\u57df\u4eba\u5458\u5728\u540c\u4e00\u9879\u76ee\u5185\u6309\u5408\u89c4\u8fb9\u754c\u72ec\u7acb\u4f5c\u4e1a\uff0c\u6570\u636e\u6309\u9700\u53ef\u89c1\u3001\u4e92\u4e0d\u5e72\u6270\u3002<\/li>\n<li>\u8d28\u91cf\u95e8\u7981\u4e0e\u98ce\u9669\u7ba1\u7406\u524d\u7f6e\uff1a\u652f\u6301\u5728\u7814\u53d1\u6d41\u6c34\u7ebf\u4e2d\u5d4c\u5165\u533b\u7597\u7279\u6709\u7684\u8d28\u91cf\u8bc4\u5ba1\u8282\u70b9\uff08\u5982\u8bbe\u8ba1\u53d8\u66f4\u5f71\u54cd\u8bc4\u4f30\u3001\u4e34\u5e8a\u9a8c\u8bc1\u95e8\u7981\uff09\uff0c\u5c06\u98ce\u9669\u7ba1\u63a7\u4ece\u4e8b\u540e\u8865\u6551\u524d\u7f6e\u4e3a\u8fc7\u7a0b\u62e6\u622a\uff0c\u4fdd\u969c\u4ea4\u4ed8\u7269\u7b26\u5408\u5b89\u5168\u6709\u6548\u6027\u5e95\u7ebf\u3002<\/li>\n<\/ul>\n<p>\u9002\u7528\u573a\u666f\uff1a\u9ad8\u5ea6\u9002\u914d\u533b\u7597\u5668\u68b0\u5d4c\u5165\u5f0f\u8f6f\u4ef6\u7814\u53d1\u3001\u533b\u836f\u6570\u5b57\u5316\u5e73\u53f0\u5efa\u8bbe\u53ca\u4e92\u8054\u7f51\u533b\u9662\u8fed\u4ee3\u3002\u5c24\u5176\u9488\u5bf9\u9700\u5e94\u5bf9\u4e25\u82db\u5408\u89c4\u5ba1\u8ba1\u3001\u591a\u5b66\u79d1\u4ea4\u53c9\u534f\u4f5c\u53ca\u5f3a\u8c03\u5168\u751f\u547d\u5468\u671f\u6587\u6863\u53d7\u63a7\u7684\u767e\u4eba\u7ea7\u4ee5\u4e0a\u533b\u7597\u7814\u53d1\u7ec4\u7ec7\uff0cONES\u80fd\u5c06\u5408\u89c4\u8981\u6c42\u65e0\u7f1d\u8f6c\u5316\u4e3a\u65e5\u5e38\u7814\u53d1\u52a8\u4f5c\u3002<\/p>\n<p>\u4f18\u52bf\u4eae\u70b9\uff1aONES\u7684\u6700\u5927\u4ef7\u503c\u5728\u4e8e\u5c06\u300c\u5408\u89c4\u8d1f\u62c5\u300d\u8f6c\u5316\u4e3a\u300c\u7814\u53d1\u52a8\u80fd\u300d\u3002\u5176\u4e0d\u8981\u6c42\u56e2\u961f\u6539\u53d8\u654f\u6377\u4e60\u60ef\u53bb\u8fce\u5408\u76d1\u7ba1\uff0c\u800c\u662f\u901a\u8fc7\u5e95\u5c42\u67b6\u6784\u7684\u8ffd\u6eaf\u5173\u8054\u4e0e\u81ea\u52a8\u5316\u6d41\u8f6c\uff0c\u8ba9\u5408\u89c4\u8bc1\u636e\u5728\u7814\u53d1\u63a8\u8fdb\u4e2d\u81ea\u7136\u6c89\u6dc0\u3002\u9009\u578b\u56e2\u961f\u53ef\u4f18\u5148\u5728\u6838\u5fc3\u4ea7\u54c1\u7ebf\u542f\u52a8\u9700\u6c42\u8ffd\u6eaf\u6a21\u5757\uff0c\u4ee5\u4e00\u6761\u9ad8\u98ce\u9669\u7279\u6027\u4e3a\u8bd5\u70b9\uff0c\u9a8c\u8bc1\u5176\u7aef\u5230\u7aef\u95ed\u73af\u6548\u80fd\uff0c\u518d\u9010\u6b65\u6a2a\u5411\u6269\u5c55\u81f3\u5168\u7ec4\u7ec7\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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31+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>Tower 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21 CFR Part 11\uff09\u3001\u9700\u4e25\u683c\u5ba1\u8ba1\u8ffd\u8e2a\u4e0e\u7535\u5b50\u7b7e\u540d\u7684\u786c\u6838\u7814\u53d1\u573a\u666f\uff0cTower\u65e0\u6cd5\u80dc\u4efb\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5b66\u4e60\u6210\u672c\u6781\u4f4e\uff0c\u56e2\u961f\u53ef\u5728\u4e00\u4e24\u5929\u5185\u5feb\u901f\u542f\u7528\u5e76\u8dd1\u901a\u654f\u6377\u6d41\u7a0b\uff1b\u754c\u9762\u4ea4\u4e92\u4f53\u9a8c\u4f18\u79c0\uff0c\u8f7b\u91cf\u7075\u6d3b\uff1b\u8ba2\u9605\u6210\u672c\u8f83\u4f4e\uff0c\u9002\u5408\u9884\u7b97\u6709\u9650\u4e14\u5904\u4e8e\u6982\u5ff5\u9a8c\u8bc1\u9636\u6bb5\u7684\u521d\u521b\u5065\u5eb7\u56e2\u961f\u4f5c\u4e3a\u8fc7\u6e21\u6027\u5de5\u5177\u4f7f\u7528\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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31+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<\/strong>\uff1a\u4f5c\u4e3a\u5168\u7403\u5e94\u7528\u6700\u5e7f\u6cdb\u7684\u654f\u6377\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0cJira\u51ed\u501f\u5176\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684Issue\u8ddf\u8e2a\u673a\u5236\u4e0e\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u6784\u5efa\u4e86\u8de8\u884c\u4e1a\u7684\u7814\u53d1\u7ba1\u7406\u5e95\u5ea7\u3002\u7136\u800c\uff0c\u5176\u5f00\u7bb1\u5373\u7528\u7684\u6807\u51c6\u914d\u7f6e\u66f4\u504f\u5411\u901a\u7528\u8f6f\u4ef6\u7814\u53d1\uff0c\u5728\u5e94\u5bf9\u5f3a\u76d1\u7ba1\u884c\u4e1a\u65f6\uff0c\u5f80\u5f80\u9700\u8981\u4f9d\u8d56\u6df1\u5ea6\u914d\u7f6e\u4e0e\u7b2c\u4e09\u65b9\u6269\u5c55\u6765\u8865\u9f50\u5408\u89c4\u77ed\u677f\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1a<\/p>\n<ul>\n<li><strong>\u53ef\u8ffd\u6eaf\u6027\u77e9\u9635\u6784\u5efa<\/strong>\uff1a\u901a\u8fc7Issue\u5173\u8054\u4e0e\u63d2\u4ef6\u652f\u6301\uff0c\u53ef\u5b9e\u73b0\u9700\u6c42\u3001\u4ee3\u7801\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u7684\u7aef\u5230\u7aef\u8ffd\u8e2a\uff0c\u4f46\u9700\u6295\u5165\u8f83\u591a\u524d\u671f\u6cbb\u7406\u6210\u672c\u6765\u7ef4\u62a4\u94fe\u63a5\u7684\u5b8c\u6574\u6027\uff0c\u4ee5\u6ee1\u8db3FDA 21 CFR Part 11\u7684\u5ba1\u8ba1\u8981\u6c42\u3002<\/li>\n<li><strong>\u5408\u89c4\u5de5\u4f5c\u6d41\u5f3a\u5236<\/strong>\uff1a\u5229\u7528\u5176\u5f3a\u5927\u7684\u5de5\u4f5c\u6d41\u5f15\u64ce\uff0c\u53ef\u5bf9\u533b\u7597\u8f6f\u4ef6\u7684\u53d8\u66f4\u63a7\u5236\u8bbe\u7f6e\u5f3a\u5236\u7684\u5ba1\u6279\u95e8\u7981\u4e0e\u7535\u5b50\u7b7e\u540d\uff0c\u786e\u4fdd\u7814\u53d1\u6d41\u7a0b\u7b26\u5408IEC 62304\u6807\u51c6\u4e0b\u7684\u8fc7\u7a0b\u7ea6\u675f\u3002<\/li>\n<li><strong>\u9a8c\u8bc1\u4e0e\u786e\u8ba4(V&amp;V)\u96c6\u6210<\/strong>\uff1a\u9700\u501f\u52a9Xray\u6216Zephyr\u7b49\u6d4b\u8bd5\u7ba1\u7406\u63d2\u4ef6\uff0c\u65b9\u80fd\u642d\u5efa\u7b26\u5408\u533b\u7597\u884c\u4e1a\u89c4\u8303\u7684V\u6a21\u578b\u9a8c\u8bc1\u73af\u5883\uff0c\u5b9e\u73b0\u6d4b\u8bd5\u6267\u884c\u4e0e\u7f3a\u9677\u95ed\u73af\u7684\u7ed3\u6784\u5316\u7ba1\u7406\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9002\u5408\u5177\u5907\u6210\u719fIT\u6cbb\u7406\u4f53\u7cfb\u3001\u62e5\u6709\u4e13\u804cJira\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\u8ffd\u6c42\u5f00\u7bb1\u5373\u7528\u5408\u89c4\u80fd\u529b\u7684\u4e2d\u5c0f\u578b\u533b\u7597\u5668\u68b0\u56e2\u961f\u800c\u8a00\uff0c\u5176\u843d\u5730\u95e8\u69db\u4e0e\u9690\u6027\u6210\u672c\u504f\u9ad8\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1a\u654f\u6377\u7ba1\u7406\u8303\u5f0f\u6210\u719f\uff0c\u5de5\u4f5c\u6d41\u81ea\u5b9a\u4e49\u80fd\u529b\u6781\u5f3a\uff1b\u5f00\u53d1\u8005\u751f\u6001\u65e0\u53ef\u5339\u654c\uff0c\u51e0\u4e4e\u80fd\u4e0e\u6240\u6709\u4e3b\u6d41DevOps\u5de5\u5177\u94fe\u65e0\u7f1d\u96c6\u6210\uff1b\u793e\u533a\u8d44\u6e90\u4e30\u5bcc\uff0c\u4fbf\u4e8e\u89e3\u51b3\u590d\u6742\u914d\u7f6e\u95ee\u9898\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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31+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\u6df1\u539a\u7684\u751f\u6001\u5e95\u5ea7\uff0c\u5b83\u5df2\u6210\u4e3a\u5927\u578b\u4f01\u4e1a\u6784\u5efa\u6807\u51c6\u5316\u7814\u53d1\u6d41\u6c34\u7ebf\u7684\u6838\u5fc3\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>\u4f01\u4e1a\u7ea7\u5408\u89c4\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u5185\u7f6e\u9ad8\u5ea6\u53ef\u914d\u7f6e\u7684\u5ba1\u8ba1\u65e5\u5fd7\u4e0e\u6743\u9650\u7ba1\u63a7\u4f53\u7cfb\uff0c\u6ee1\u8db3\u533b\u7597\u884c\u4e1aFDA 21 CFR Part 11\u7b49\u4e25\u82db\u5408\u89c4\u8981\u6c42\uff0c\u786e\u4fdd\u7814\u53d1\u8fc7\u7a0b\u5168\u94fe\u8def\u64cd\u4f5c\u7559\u75d5\u4e0e\u9632\u7be1\u6539\u3002<\/li>\n<li><strong>\u81ea\u52a8\u5316CI\/CD\u4e0e\u5b89\u5168\u5de6\u79fb\uff1a<\/strong>\u901a\u8fc7Azure Pipelines\u4e0eDefender\u96c6\u6210\uff0c\u5728\u533b\u7597\u8f6f\u4ef6\u4ea4\u4ed8\u4e2d\u5f3a\u5236\u6267\u884c\u9759\u6001\u4ee3\u7801\u5b89\u5168\u626b\u63cf\u4e0e\u4f9d\u8d56\u6f0f\u6d1e\u68c0\u67e5\uff0c\u4fdd\u969c\u60a3\u8005\u6570\u636e\u5b89\u5168\u4e0e\u7cfb\u7edf\u9ad8\u53ef\u7528\u6027\u3002<\/li>\n<li><strong>\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong>\u652f\u6301Work Item\u4e0e\u4ee3\u7801\u3001PR\u53ca\u90e8\u7f72\u7684\u6df1\u5ea6\u5173\u8054\uff0c\u4e3a\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684IEC 62304\u8ba4\u8bc1\u63d0\u4f9b\u4ece\u9700\u6c42\u5230\u53d1\u5e03\u7684\u5b8c\u6574\u8ffd\u6eaf\u77e9\u9635\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5177\u5907\u4e00\u5b9a\u7814\u53d1\u89c4\u6a21\u3001\u91cd\u5ea6\u4f9d\u8d56\u5fae\u8f6f\u6280\u672f\u6808\uff0c\u4e14\u9700\u6784\u5efa\u4e25\u683c\u5408\u89c4\u6d41\u6c34\u7ebf\u4e0e\u81ea\u52a8\u5316\u6d4b\u8bd5\u95ed\u73af\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u5c24\u5176\u9488\u5bf9SaaS\u5316\u533b\u7597\u5e73\u53f0\u6216AI\u8bca\u65ad\u8f6f\u4ef6\u7684\u6301\u7eed\u4ea4\u4ed8\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u6574\u5408\u80fd\u529b\u6781\u5f3a\uff0c\u4e0eGitHub\u3001Azure\u4e91\u539f\u751f\u5b89\u5168\u670d\u52a1\u65e0\u7f1d\u8054\u52a8\uff1b\u6d41\u6c34\u7ebf\u5373\u4ee3\u7801\u4fdd\u969c\u4e86\u533b\u7597\u4ea4\u4ed8\u7684\u786e\u5b9a\u6027\u4e0e\u53ef\u91cd\u590d\u6027\uff1b\u7075\u6d3b\u7684\u6d41\u7a0b\u6a21\u677f\u80fd\u652f\u6491\u4ece\u4f20\u7edf\u7011\u5e03\u5230\u654f\u6377\u7684\u5e73\u6ed1\u8fc7\u6e21\uff0c\u964d\u4f4e\u5408\u89c4\u8f6c\u578b\u6469\u64e6\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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31+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\u4e3a\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u6253\u9020\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5e73\u53f0\uff0c\u6df1\u8015\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u8ffd\u8e2a\u4e0e\u7f3a\u9677\u95ed\u73af\uff0c\u4ee5\u7aef\u5230\u7aef\u7684\u53ef\u8ffd\u6eaf\u6027\u4e0e\u4e25\u82db\u7684\u5408\u89c4\u5ba1\u8ba1\u80fd\u529b\u89c1\u957f\uff0c\u662f\u4f20\u7edf\u4e25\u76d1\u7ba1\u9886\u57df\u7684\u91cd\u5ea6\u9009\u578b\u76ee\u6807\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u53cc\u5411\u8ffd\u6eaf\u4f53\u7cfb\uff1a<\/strong>\u5b9e\u73b0\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u3001\u8bbe\u8ba1\u89c4\u8303\u5230\u6d4b\u8bd5\u7528\u4f8b\u4e0e\u7f3a\u9677\u7684\u53cc\u5411\u5b9e\u65f6\u5173\u8054\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u4e0eIEC 62304\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u4e0e\u9632\u7be1\u6539\u7684\u4e25\u82db\u5ba1\u67e5\u8981\u6c42\u3002<\/li>\n<li><strong>\u5185\u7f6e\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u539f\u751f\u652f\u6301\u7b26\u5408\u89c4\u8303\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u4e0d\u53ef\u7be1\u6539\u7684\u64cd\u4f5c\u65e5\u5fd7\uff0c\u65e0\u9700\u989d\u5916\u5f00\u53d1\u5373\u53ef\u843d\u5730\u533b\u7597\u8f6f\u4ef6\u7814\u53d1\u7684\u5408\u89c4\u9632\u7ebf\uff0c\u5927\u5e45\u964d\u4f4e\u8fce\u5ba1\u6210\u672c\u3002<\/li>\n<li><strong>\u98ce\u9669\u4e0e\u9700\u6c42\u8054\u52a8\u7ba1\u63a7\uff1a<\/strong>\u63d0\u4f9b\u98ce\u9669\u5206\u6790\u77e9\u9635\uff0c\u5c06\u5371\u5bb3\u5206\u6790\u4e0e\u9700\u6c42\u57fa\u7ebf\u76f4\u63a5\u6302\u94a9\uff0c\u786e\u4fdd\u533b\u7597\u5668\u68b0\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u5728\u7814\u53d1\u6d41\u7a0b\u4e2d\u88ab\u7cbe\u51c6\u9a8c\u8bc1\u4e0e\u95ed\u73af\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u5fc5\u987b\u901a\u8fc7FDA\u3001CE\u7b49\u4e25\u82db\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u53ca\u4e09\u7c7b\u5668\u68b0\u7814\u53d1\u56e2\u961f\uff0c\u5c24\u5176\u9002\u5408\u5bf9\u5408\u89c4\u5ba1\u8ba1\u4e0e\u8ffd\u6eaf\u6027\u6709\u96f6\u5bb9\u5fcd\u8981\u6c42\u3001\u7814\u53d1\u6d41\u7a0b\u6781\u5ea6\u6807\u51c6\u5316\u7684\u4f20\u7edf\u533b\u7597\u4f01\u4e1a\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\u7c92\u5ea6\u3002\u4f46\u9700\u5ba2\u89c2\u5ba1\u89c6\uff0c\u5176UI\u4ea4\u4e92\u4e0e\u654f\u6377\u9002\u914d\u6027\u504f\u4f20\u7edf\uff0c\u5b66\u4e60\u66f2\u7ebf\u9661\u5ced\uff0c\u4e14\u672c\u5730\u5316\u90e8\u7f72\u6210\u672c\u8f83\u9ad8\uff0c\u9009\u578b\u65f6\u9700\u6743\u8861\u5408\u89c4\u6536\u76ca\u4e0e\u654f\u6377\u6548\u7387\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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31+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\u7aef\u5230\u7aef\u9700\u6c42\u53ca\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\u3002\u5b83\u4ee5\u9700\u6c42\u5b9a\u4e49\u4e0e\u8ffd\u6eaf\u4e3a\u6838\u5fc3\uff0c\u6784\u5efa\u4e86\u8986\u76d6\u7cfb\u7edf\u751f\u547d\u5468\u671f\u5168\u94fe\u8def\u7684\u95ed\u73af\u7ba1\u7406\u67b6\u6784\uff0c\u5728\u822a\u7a7a\u3001\u6c7d\u8f66\u4e0e\u533b\u7597\u7b49\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u6df1\u8015\u591a\u5e74\uff0c\u662f\u4e1a\u754c\u516c\u8ba4\u7684\u9700\u6c42\u9a71\u52a8\u578b\u7814\u53d1\u7ba1\u63a7\u5229\u5668\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\u8ffd\u6eaf\u94fe\u6784\u5efa\uff1a<\/strong>\u63d0\u4f9b\u884c\u4e1a\u9886\u5148\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u80fd\u81ea\u52a8\u5efa\u7acb\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u8bbe\u8ba1\u5230\u9a8c\u8bc1\u6d4b\u8bd5\u7684\u5b9e\u65f6\u5173\u8054\uff0c\u786e\u4fdd\u533b\u7597\u4ea7\u54c1\u7814\u53d1\u5168\u94fe\u8def\u65e0\u9700\u6c42\u65ad\u5c42\uff0c\u8f7b\u677e\u5e94\u5bf9FDA\u7b49\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u67e5\u3002<\/li>\n<li><strong>\u5185\u7f6e\u5408\u89c4\u6846\u67b6\u4e0e\u9a8c\u8bc1\u652f\u6301\uff1a<\/strong>\u9884\u7f6eIEC 62304\u3001ISO 14971\u7b49\u533b\u7597\u884c\u4e1a\u5408\u89c4\u6a21\u677f\u4e0e\u98ce\u9669\u8bc4\u4f30\u6a21\u578b\uff0c\u5e76\u63d0\u4f9b\u7b26\u5408GxP\u89c4\u8303\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u6279\u6d41\uff0c\u5927\u5e45\u7f29\u77ed\u8f6f\u4ef6\u9a8c\u8bc1\u5468\u671f\u3002<\/li>\n<li><strong>\u5b9e\u65f6\u98ce\u9669\u4e0e\u5371\u5bb3\u5206\u6790\u8054\u52a8\uff1a<\/strong>\u5c06\u5371\u5bb3\u5206\u6790\u6df1\u5ea6\u878d\u5165\u9700\u6c42\u4e0e\u6d4b\u8bd5\u6d41\u7a0b\uff0c\u5b9e\u73b0\u98ce\u9669\u63a7\u5236\u9879\u7684\u53cc\u5411\u8ffd\u8e2a\uff0c\u786e\u4fdd\u533b\u7597\u8bbe\u5907\u7814\u53d1\u4e2d\u7684\u98ce\u9669\u7f13\u89e3\u63aa\u65bd\u88ab\u6709\u6548\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u4e0e\u786c\u4ef6\u7ed3\u5408\u7684\u590d\u6742\u7cfb\u7edf\u7814\u53d1\uff0c\u7279\u522b\u662f\u5bf9IEC 62304\u5408\u89c4\u6709\u5f3a\u5236\u8981\u6c42\u3001\u9700\u9891\u7e41\u5e94\u5bf9FDA\u6216NMPA\u5ba1\u67e5\uff0c\u4e14\u6781\u5ea6\u4f9d\u8d56\u9700\u6c42\u8ffd\u6eaf\u4e0e\u98ce\u9669\u7ba1\u7406\u7684\u4e8c\u7c7b\u3001\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u7814\u53d1\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6838\u5fc3\u58c1\u5792\u5728\u4e8e\u5c06\u9700\u6c42\u3001\u98ce\u9669\u4e0e\u6d4b\u8bd5\u9a8c\u8bc1\u6df1\u5ea6\u8026\u5408\u7684\u8ffd\u6eaf\u80fd\u529b\uff0c\u6709\u6548\u89c4\u907f\u4e86\u5408\u89c4\u4ea4\u4ed8\u4e2d\u7684\u903b\u8f91\u65ad\u5c42\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u654f\u6377\u9879\u76ee\u7ba1\u7406\u4e0e\u65e5\u5e38\u534f\u4f5c\u529f\u80fd\u76f8\u5bf9\u8f83\u5f31\uff0c\u5bf9\u4e8e\u8ffd\u6c42\u8f7b\u91cf\u654f\u6377\u8fed\u4ee3\u7684\u7eaf\u8f6f\u4ef6\u56e2\u961f\u800c\u8a00\u7565\u663e\u7b28\u91cd\uff0c\u9009\u578b\u65f6\u9700\u5728\u5408\u89c4\u521a\u6027\u4e0e\u654f\u6377\u67d4\u6027\u95f4\u5ba1\u614e\u6743\u8861\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\u63a8\u8350\u54ea\u6b3e\u9760\u8c31+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%EF%BC%9A%E5%A6%82%E4%BD%95%E9%94%9A%E5%AE%9A%E6%9C%80%E9%80%82%E5%90%88%E7%9A%84%E7%A0%94%E5%8F%91%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F\"><\/span>\u9009\u578b\u5efa\u8bae\u4e0e\u603b\u7ed3\uff1a\u5982\u4f55\u951a\u5b9a\u6700\u9002\u5408\u7684\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9488\u5bf9\u201c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u63a8\u8350\u54ea\u6b3e\u9760\u8c31\u201d\u8fd9\u4e00\u95ee\u9898\uff0c\u6ca1\u6709\u653e\u4e4b\u56db\u6d77\u800c\u7686\u51c6\u7684\u7b54\u6848\uff0c\u4f01\u4e1a\u9700\u6839\u636e\u81ea\u8eab\u89c4\u6a21\u3001\u7814\u53d1\u8303\u5f0f\u4e0e\u5408\u89c4\u7b49\u7ea7\u8fdb\u884c\u5339\u914d\uff1a<\/p>\n<ol>\n<li><strong>\u5f3a\u5408\u89c4\u9a71\u52a8\u7684\u4f20\u7edf\u533b\u7597\u5668\u68b0\u4f01\u4e1a<\/strong>\uff1a\u82e5\u6838\u5fc3\u8bc9\u6c42\u662f\u96f6\u59a5\u534f\u7684\u5408\u89c4\u5ba1\u8ba1\u4e0e\u7aef\u5230\u7aef\u8ffd\u6eaf\uff0c<strong>Helix ALM<\/strong>\u4e0e<strong>Jama Connect<\/strong>\u662f\u9996\u9009\uff0c\u5b83\u4eec\u5929\u751f\u4e3aIEC 62304\u800c\u751f\uff0c\u80fd\u6781\u5927\u964d\u4f4e\u5408\u89c4\u4e3e\u8bc1\u6210\u672c\u3002<\/li>\n<li><strong>\u654f\u6377\u4e0e\u5408\u89c4\u5e76\u91cd\u7684\u5927\u578b\u533b\u7597\u79d1\u6280\u56e2\u961f<\/strong>\uff1a\u82e5\u56e2\u961f\u5177\u5907\u8f83\u5f3a\u7684\u6280\u672f\u914d\u7f6e\u80fd\u529b\u4e14\u91c7\u7528\u6df7\u5408\u5f00\u53d1\u6a21\u5f0f\uff0c<strong>ONES<\/strong>\u6216<strong>Azure DevOps<\/strong>\u80fd\u591f\u517c\u987e\u654f\u6377\u6548\u7387\u4e0e\u5408\u89c4\u7ba1\u63a7\uff0c\u901a\u8fc7\u5b9a\u5236\u5316\u642d\u5efa\u6ee1\u8db3\u5ba1\u8ba1\u8981\u6c42\u3002<\/li>\n<li><strong>\u5904\u4e8e\u5feb\u901f\u8fed\u4ee3\u671f\u7684\u6570\u5b57\u5065\u5eb7\u4e0eSaMD\u521d\u521b\u56e2\u961f<\/strong>\uff1a\u82e5\u65e9\u671f\u66f4\u770b\u91cd\u534f\u540c\u6548\u7387\u4e0e\u6210\u672c\uff0c<strong>Jira<\/strong>\u914d\u5408\u5408\u89c4\u63d2\u4ef6\uff0c\u6216\u76f4\u63a5\u91c7\u7528<strong>Tower<\/strong>\u8fdb\u884c\u8f7b\u91cf\u7ba1\u7406\uff0c\u662f\u66f4\u5177\u6027\u4ef7\u6bd4\u7684\u8d77\u6b65\u65b9\u6848\u3002<\/li>\n<\/ol>\n<p>\u603b\u7ed3\u800c\u8a00\uff0c2026\u5e74\u7684\u533b\u7597\u5065\u5eb7\u7814\u53d1\u7ba1\u7406\uff0c\u5df2\u4ece\u5355\u7eaf\u7684\u6548\u7387\u5de5\u5177\u6f14\u53d8\u4e3a\u5408\u89c4\u57fa\u7840\u8bbe\u65bd\u3002\u4f01\u4e1a\u5728\u9009\u578b\u65f6\u5e94\u7a7f\u900f\u8425\u9500\u8868\u8c61\uff0c\u76f4\u51fb\u201c\u8ffd\u6eaf\u3001\u5408\u89c4\u3001\u8d28\u91cf\u201d\u4e09\u5927\u6838\u5fc3\uff0c\u65b9\u80fd\u5728\u4e25\u76d1\u7ba1\u73af\u5883\u4e0b\u5b9e\u73b0\u7814\u53d1\u6548\u80fd\u7684\u771f\u6b63\u8dc3\u5347\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%E4%B8%BA%E4%BB%80%E4%B9%88%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%E9%9C%80%E6%B1%82%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u7279\u522b\u5f3a\u8c03\u7814\u53d1\u7ba1\u7406\u7cfb\u7edf\u7684\u9700\u6c42\u8ffd\u6eaf\u80fd\u529b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u56e0\u4e3a\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\uff08\u5982\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff09\u76f4\u63a5\u5173\u4e4e\u751f\u547d\u5b89\u5168\uff0c\u884c\u4e1a\u6cd5\u89c4\uff08\u5982ISO 62304\u3001FDA 21 CFR Part 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