{"id":736,"date":"2026-06-08T06:16:26","date_gmt":"2026-06-07T22:16:26","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=736"},"modified":"2026-06-08T06:16:26","modified_gmt":"2026-06-07T22:16:26","slug":"tool-review-best-guide-15","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/tool-review-best-guide-15","title":{"rendered":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u6df1\u5ea6\u6d4b\u8bc4\uff1a\u54ea\u4e9b\u5de5\u5177\u503c\u5f97\u5c1d\u8bd5"},"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\/tool-review-best-guide-15\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E9%9C%80%E6%B1%82%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\u9700\u6c42\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\/tool-review-best-guide-15\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u7684\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\/tool-review-best-guide-15\/#%E4%B8%BB%E6%B5%81%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%B7%A5%E5%85%B7%E9%80%9F%E8%A7%88%E4%B8%8E%E6%A0%B8%E5%BF%83%E7%89%B9%E5%BE%81\" >\u4e3b\u6d41\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u5de5\u5177\u901f\u89c8\u4e0e\u6838\u5fc3\u7279\u5f81<\/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\/tool-review-best-guide-15\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%93%AA%E4%BA%9B%E5%80%BC%E5%BE%97%E5%B0%9D%E8%AF%95%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\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\/tool-review-best-guide-15\/#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\/tool-review-best-guide-15\/#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\/tool-review-best-guide-15\/#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\/tool-review-best-guide-15\/#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\/tool-review-best-guide-15\/#Helix_RM\" >Helix RM<\/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\/tool-review-best-guide-15\/#Visure_Requirements\" >Visure Requirements<\/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\/tool-review-best-guide-15\/#%E5%B7%A5%E5%85%B7%E4%BD%BF%E7%94%A8%E5%BB%BA%E8%AE%AE%E4%B8%8E2026%E5%B9%B4%E9%80%89%E5%9E%8B%E6%80%BB%E7%BB%93\" >\u5de5\u5177\u4f7f\u7528\u5efa\u8bae\u4e0e2026\u5e74\u9009\u578b\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\/tool-review-best-guide-15\/#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\/tool-review-best-guide-15\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E5%9C%A8%E9%80%89%E6%8B%A9%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%97%B6%EF%BC%8C%E6%9C%80%E5%BA%94%E4%BC%98%E5%85%88%E8%80%83%E8%99%91%E4%BB%80%E4%B9%88%E8%83%BD%E5%8A%9B%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u5728\u9009\u62e9\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u65f6\uff0c\u6700\u5e94\u4f18\u5148\u8003\u8651\u4ec0\u4e48\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\/tool-review-best-guide-15\/#Jira%E6%98%AF%E5%90%A6%E9%80%82%E5%90%88%E7%94%A8%E4%BA%8E%E9%9C%80%E8%A6%81%E4%B8%A5%E6%A0%BC%E5%90%88%E8%A7%84%E7%9A%84%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E8%BD%AF%E4%BB%B6%E7%A0%94%E5%8F%91%EF%BC%9F\" >Jira\u662f\u5426\u9002\u5408\u7528\u4e8e\u9700\u8981\u4e25\u683c\u5408\u89c4\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\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\/tool-review-best-guide-15\/#%E4%B8%BA%E4%BB%80%E4%B9%88Helix_RM%E5%92%8CVisure_Requirements%E5%B8%B8%E8%A2%AB%E6%8E%A8%E8%8D%90%E7%BB%99%E7%94%9F%E5%91%BD%E7%A7%91%E5%AD%A6%E9%A2%86%E5%9F%9F%EF%BC%9F\" >\u4e3a\u4ec0\u4e48Helix RM\u548cVisure Requirements\u5e38\u88ab\u63a8\u8350\u7ed9\u751f\u547d\u79d1\u5b66\u9886\u57df\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\/tool-review-best-guide-15\/#%E5%AF%B9%E4%BA%8E%E6%B3%A8%E9%87%8D%E6%82%A3%E8%80%85%E6%95%B0%E6%8D%AE%E9%9A%90%E7%A7%81%E7%9A%84%E5%9B%BD%E5%86%85%E5%8C%BB%E7%96%97%E6%9C%BA%E6%9E%84%EF%BC%8C%E9%83%A8%E7%BD%B2%E6%96%B9%E5%BC%8F%E6%9C%89%E4%BD%95%E5%BB%BA%E8%AE%AE%EF%BC%9F\" >\u5bf9\u4e8e\u6ce8\u91cd\u60a3\u8005\u6570\u636e\u9690\u79c1\u7684\u56fd\u5185\u533b\u7597\u673a\u6784\uff0c\u90e8\u7f72\u65b9\u5f0f\u6709\u4f55\u5efa\u8bae\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%E9%9C%80%E6%B1%82%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\u9700\u6c42\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\u4ece\u8fdc\u7a0b\u8bca\u7597\u5e73\u53f0\u5230\u9662\u5185\u6838\u5fc3\u4e1a\u52a1\u7cfb\u7edf\uff0c\u9700\u6c42\u7684\u590d\u6742\u6027\u4e0e\u5408\u89c4\u6027\u8981\u6c42\u5747\u8fbe\u5230\u4e86\u524d\u6240\u672a\u6709\u7684\u9ad8\u5ea6\u3002\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u9700\u6c42\u7ba1\u7406\u4e0d\u4ec5\u5173\u4e4e\u4ea7\u54c1\u4ea4\u4ed8\u7684\u6548\u7387\uff0c\u66f4\u76f4\u63a5\u6d89\u53ca\u60a3\u8005\u5b89\u5168\u3001\u6570\u636e\u9690\u79c1\u53ca\u884c\u4e1a\u6cd5\u89c4\u7684\u9075\u4ece\u3002\u9762\u5bf9\u6d77\u91cf\u7684\u4e34\u5e8a\u53cd\u9988\u4e0e\u4e25\u82db\u7684\u5408\u89c4\u5ba1\u8ba1\uff0c\u4f20\u7edf\u7684\u6587\u6863\u9a71\u52a8\u6a21\u5f0f\u5df2\u96be\u4ee5\u4e3a\u7ee7\u3002\u672c\u6587\u5c06\u4ee5\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u4e3a\u4e3b\u8f74\uff0c\u4e3a\u60a8\u7cfb\u7edf\u68b3\u7406\u5f53\u524d\u4e3b\u6d41\u7684\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\uff0c\u6df1\u5ea6\u89e3\u6790\u54ea\u4e9b\u5de5\u5177\u503c\u5f97\u5c1d\u8bd5\uff0c\u52a9\u529b\u4f01\u4e1a\u6784\u5efa\u9ad8\u6548\u3001\u5408\u89c4\u7684\u9700\u6c42\u7ba1\u7406\u95ed\u73af\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%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u7684\u9009\u578b\u65b9\u6cd5\u4e0e\u6838\u5fc3\u6d4b\u8bc4\u7ef4\u5ea6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8bc4\u4f302026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\u65f6\uff0c\u5fc5\u987b\u5efa\u7acb\u8d34\u5408\u884c\u4e1a\u7279\u6027\u7684\u6d4b\u8bc4\u7ef4\u5ea6\u3002\u6211\u4eec\u57fa\u4e8e\u4ee5\u4e0b\u56db\u5927\u6838\u5fc3\u7ef4\u5ea6\u6784\u5efa\u9009\u578b\u65b9\u6cd5\u4f53\u7cfb\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\u5065\u5eb7\u884c\u4e1a\u5173\u8054\u6027<\/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\u65e5\u5fd7<\/td>\n<td>\u6ee1\u8db3FDA 21 CFR Part 11\u3001HIPAA\u7b49\u6cd5\u89c4\u8981\u6c42<\/td>\n<\/tr>\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<\/td>\n<td>\u4fdd\u969c\u60a3\u8005PHI\u6570\u636e\u4e0e\u533b\u7597\u6838\u5fc3\u8d44\u4ea7\u5b89\u5168<\/td>\n<\/tr>\n<tr>\n<td>\u8de8\u56e2\u961f\u534f\u4f5c\u80fd\u529b<\/td>\n<td>\u591a\u90e8\u95e8\u534f\u540c\u3001\u4e34\u5e8a\u53cd\u9988\u8054\u52a8\u3001\u654f\u6377\u4e0e\u7011\u5e03\u6df7\u5408\u652f\u6301<\/td>\n<td>\u6253\u901a\u4e34\u5e8a\u4e13\u5bb6\u3001\u7814\u53d1\u4e0e\u5408\u89c4\u56e2\u961f\u7684\u6c9f\u901a\u58c1\u5792<\/td>\n<\/tr>\n<tr>\n<td>\u7cfb\u7edf\u96c6\u6210\u4e0e\u6269\u5c55<\/td>\n<td>\u5f00\u653eAPI\u3001\u4e0eCI\/CD\u53ca\u6d4b\u8bd5\u5de5\u5177\u7684\u539f\u751f\u96c6\u6210<\/td>\n<td>\u5b9e\u73b0\u4ece\u9700\u6c42\u5230\u9a8c\u8bc1\u7684\u81ea\u52a8\u5316\u4ea4\u4ed8\u94fe\u8def<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%BB%E6%B5%81%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%B7%A5%E5%85%B7%E9%80%9F%E8%A7%88%E4%B8%8E%E6%A0%B8%E5%BF%83%E7%89%B9%E5%BE%81\"><\/span>\u4e3b\u6d41\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u5de5\u5177\u901f\u89c8\u4e0e\u6838\u5fc3\u7279\u5f81<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8fdb\u5165\u6df1\u5ea6\u6d4b\u8bc4\u4e4b\u524d\uff0c\u6211\u4eec\u5148\u5bf9\u5165\u9009\u7684\u516d\u6b3e\u5de5\u5177\u8fdb\u884c\u5168\u666f\u5f0f\u901f\u89c8\uff0c\u4e86\u89e3\u5b83\u4eec\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u4e0a\u7684\u57fa\u672c\u76d8\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u63d0\u4f9b\u5f3a\u5927\u7684\u9879\u76ee\u7ec4\u5408\u4e0e\u9700\u6c42\u95ed\u73af\u7ba1\u7406\uff0c\u5177\u5907\u7cbe\u7ec6\u5316\u7684\u6743\u9650\u4f53\u7cfb\u4e0e\u672c\u5730\u5316\u79c1\u6709\u90e8\u7f72\u4f18\u52bf\uff0c\u9002\u5408\u5bf9\u6570\u636e\u5b89\u5168\u4e0e\u5408\u89c4\u5ba1\u8ba1\u6709\u9ad8\u8981\u6c42\u7684\u5927\u578b\u533b\u7597\u673a\u6784\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u4ee5\u8f7b\u91cf\u7ea7\u534f\u540c\u89c1\u957f\uff0c\u64cd\u4f5c\u95e8\u69db\u4f4e\uff0c\u9002\u5408\u533b\u7597\u521d\u521b\u56e2\u961f\u6216\u975e\u6280\u672f\u80cc\u666f\u7684\u4e34\u5e8a\u8fd0\u8425\u56e2\u961f\u8fdb\u884c\u8f7b\u91cf\u7ea7\u9700\u6c42\u6536\u96c6\u4e0e\u4efb\u52a1\u8ffd\u8e2a\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u654f\u6377\u5f00\u53d1\u9886\u57df\u7684\u6807\u6746\uff0c\u62e5\u6709\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u53ef\u901a\u8fc7\u6269\u5c55\u5b9e\u73b0\u5408\u89c4\u8ffd\u6eaf\uff0c\u9002\u5408\u91c7\u7528\u654f\u6377\u8fed\u4ee3\u6a21\u5f0f\u7684\u533b\u7597\u4e92\u8054\u7f51\u4ea7\u54c1\u56e2\u961f\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u4e0b\u7684\u5168\u80fd\u9009\u624b\uff0c\u63d0\u4f9b\u4ece\u9700\u6c42\u5230CI\/CD\u7684\u5168\u94fe\u8def\u7ba1\u7406\uff0c\u4e0e\u4e91\u670d\u52a1\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u9002\u5408\u6280\u672f\u5b9e\u529b\u96c4\u539a\u4e14\u5168\u9762\u4e0a\u4e91\u7684\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u3002<\/li>\n<li><strong>Helix RM<\/strong>\uff1a\u4e13\u6ce8\u4e8e\u9700\u6c42\u4e0e\u5408\u89c4\u7ba1\u7406\uff0c\u5185\u7f6e\u533b\u7597\u884c\u4e1a\u5408\u89c4\u6a21\u677f\u4e0e\u8ffd\u6eaf\u77e9\u9635\uff0c\u662f\u533b\u7597\u5668\u68b0\u4e0e\u751f\u547d\u79d1\u5b66\u9886\u57df\u7684\u91cd\u5ea6\u5408\u89c4\u9996\u9009\u3002<\/li>\n<li><strong>Visure Requirements<\/strong>\uff1a\u4e1a\u754c\u77e5\u540d\u7684\u4e13\u4e1a\u9700\u6c42\u5de5\u7a0b\u5de5\u5177\uff0c\u6df1\u690d\u4e8e\u5b89\u5168\u5173\u952e\u578b\u7cfb\u7edf\u9886\u57df\uff0c\u63d0\u4f9b\u5f00\u7bb1\u5373\u7528\u7684\u533b\u7597\u6807\u51c6\u5408\u89c4\u6a21\u5757\uff0c\u9002\u5408\u9ad8\u7b49\u7ea7\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\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%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%93%AA%E4%BA%9B%E5%80%BC%E5%BE%97%E5%B0%9D%E8%AF%95%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\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\uff1a<\/strong>ONES\u4f5c\u4e3a\u56fd\u5185\u9886\u5148\u7684\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u57282026\u5e74\u7684\u8fed\u4ee3\u4e2d\u5df2\u6784\u5efa\u51fa\u9ad8\u5ea6\u6210\u719f\u7684\u4f01\u7ea7\u9700\u6c42\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u95ed\u73af\u3002\u5176\u5e95\u5c42\u67b6\u6784\u517c\u987e\u654f\u6377\u4e0e\u89c4\u8303\uff0c\u4e3a\u533b\u7597\u5065\u5eb7\u8fd9\u7c7b\u5f3a\u5408\u89c4\u3001\u957f\u5468\u671f\u7684\u884c\u4e1a\u63d0\u4f9b\u4e86\u575a\u5b9e\u7684\u6570\u5b57\u5316\u57fa\u5ea7\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u5f3a\u5408\u89c4\u9700\u6c42\u8ffd\u6eaf\u94fe\u8def\uff1a<\/strong>\u652f\u6301\u4ece\u4e34\u5e8a\u4e1a\u52a1\u8bc9\u6c42\u5230\u7cfb\u7edf\u7528\u4f8b\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\u3002\u9762\u5bf9\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7684\u4e25\u82db\u5ba1\u8ba1\uff0cONES\u80fd\u4e00\u952e\u8f93\u51fa\u7b26\u5408ISO 13485\u4e0eIEC 62304\u6807\u51c6\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u786e\u4fdd\u9700\u6c42\u65e0\u65ad\u5c42\u3002<\/li>\n<li><strong>\u591a\u89d2\u8272\u534f\u540c\u4e0e\u6743\u9650\u9694\u79bb\uff1a<\/strong>\u533b\u7597\u9879\u76ee\u6d89\u53ca\u4e34\u5e8a\u4e13\u5bb6\u3001\u5408\u89c4\u5b98\u4e0e\u7814\u53d1\u56e2\u961f\uff0c\u77e5\u8bc6\u58c1\u5792\u6df1\u3002ONES\u63d0\u4f9b\u7cbe\u7ec6\u5316\u89d2\u8272\u6743\u9650\u914d\u7f6e\uff0c\u786e\u4fdd\u60a3\u8005\u9690\u79c1\u6570\u636e\u4e0e\u6838\u5fc3\u9700\u6c42\u5728\u53d7\u63a7\u8303\u56f4\u5185\u6d41\u8f6c\uff0c\u6253\u7834\u8de8\u804c\u80fd\u6c9f\u901a\u9e3f\u6c9f\u3002<\/li>\n<li><strong>\u9700\u6c42\u57fa\u7ebf\u4e0e\u53d8\u66f4\u98ce\u63a7\uff1a<\/strong>\u533b\u7597\u9700\u6c42\u53d8\u66f4\u7275\u4e00\u53d1\u800c\u52a8\u5168\u8eab\u3002\u7cfb\u7edf\u652f\u6301\u4e25\u683c\u7684\u9700\u6c42\u57fa\u7ebf\u7ba1\u7406\uff0c\u4efb\u4f55\u53d8\u66f4\u5747\u89e6\u53d1\u5f71\u54cd\u9762\u8bc4\u4f30\u4e0e\u5ba1\u6279\u6d41\uff0c\u5c06\u4e34\u5e8a\u5408\u89c4\u98ce\u9669\u964d\u81f3\u6700\u4f4e\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u6709\u4e00\u5b9a\u89c4\u6a21\u3001\u9700\u517c\u987e\u654f\u6377\u4ea4\u4ed8\u4e0e\u5f3a\u5408\u89c4\u5ba1\u8ba1\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u5c24\u5176\u662f\u7814\u53d1\u6838\u5fc3\u8bca\u7597\u7cfb\u7edf\u3001\u4e92\u8054\u7f51\u533b\u9662\u5e73\u53f0\u53ca\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u672c\u571f\u5316\u670d\u52a1\u54cd\u5e94\u6781\u5feb\uff0c\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6a21\u677f\u5927\u5e45\u964d\u4f4e\u7cfb\u7edf\u642d\u5efa\u6210\u672c\u3002\u5ba2\u89c2\u800c\u8a00\uff0c\u82e5\u56e2\u961f\u4ec5\u505a\u8f7b\u91cf\u7ea7\u5065\u5eb7\u5c0f\u7a0b\u5e8f\u5f00\u53d1\uff0c\u5176\u91cd\u578b\u5408\u89c4\u914d\u7f6e\u7565\u663e\u5197\u4f59\uff1b\u4f46\u5bf9\u4e8e\u8ffd\u6c42\u4f53\u7cfb\u5316\u5408\u89c4\u7684\u9009\u578b\u8005\uff0cONES\u662f\u5f53\u524d\u6700\u503c\u5f97\u5c1d\u8bd5\u7684\u56fd\u4ea7\u65b9\u6848\u4e4b\u4e00\u3002<\/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\u8001\u724c\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u5e73\u53f0\uff0cTower\u4ee5\u654f\u6377\u4e0e\u6613\u7528\u4e3a\u6838\u5fc3\uff0c\u81f4\u529b\u4e8e\u964d\u4f4e\u56e2\u961f\u534f\u4f5c\u95e8\u69db\u3002\u7136\u800c\uff0c\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e25\u82db\u7684\u5408\u89c4\u8bed\u5883\u4e0b\uff0c\u5176\u8f7b\u91cf\u5316\u7279\u6027\u65e2\u662f\u6548\u7387\u7684\u50ac\u5316\u5242\uff0c\u4e5f\u662f\u4e13\u4e1a\u6df1\u5ea6\u7684\u8fb9\u754c\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u9700\u6c42\u6d41\u8f6c\u4e0e\u4efb\u52a1\u62c6\u89e3\uff1a<\/strong>\u652f\u6301\u5c06\u9ad8\u5c42\u7ea7\u9700\u6c42\u5feb\u901f\u8f6c\u5316\u4e3a\u53ef\u6267\u884c\u4efb\u52a1\uff0c\u9002\u5408\u533b\u7597\u9879\u76ee\u524d\u671f\u7684\u654f\u6377\u63a2\u7d22\u4e0e\u8de8\u804c\u80fd\u534f\u540c\uff0c\u4f46\u5728\u5904\u7406\u590d\u6742\u7684\u533b\u7597\u9700\u6c42\u8ffd\u6eaf\u94fe\u65f6\uff0c\u7f3a\u4e4f\u539f\u751f\u7684\u5c42\u7ea7\u5173\u8054\u673a\u5236\u3002<\/li>\n<li><strong>\u57fa\u7840\u5408\u89c4\u8f85\u52a9\u4e0e\u4fe1\u606f\u7559\u75d5\uff1a<\/strong>\u63d0\u4f9b\u4efb\u52a1\u8bc4\u8bba\u4e0e\u53d8\u66f4\u8bb0\u5f55\uff0c\u80fd\u5728\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u6ee1\u8db3\u533b\u7597\u9879\u76ee\u5bf9\u64cd\u4f5c\u7559\u75d5\u7684\u57fa\u7840\u8bc9\u6c42\uff0c\u4f46\u65e0\u6cd5\u81ea\u52a8\u751f\u6210\u7b26\u5408FDA 21 CFR Part 11\u6216ISO 13485\u6807\u51c6\u7684\u5408\u89c4\u5ba1\u67e5\u62a5\u544a\u3002<\/li>\n<li><strong>\u591a\u7aef\u540c\u6b65\u4e0e\u4e34\u5e8a\u53cd\u9988\u6536\u96c6\uff1a<\/strong>\u51ed\u501f\u51fa\u8272\u7684\u79fb\u52a8\u7aef\u4f53\u9a8c\uff0c\u4fbf\u4e8e\u4e34\u5e8a\u533b\u62a4\u4eba\u5458\u5feb\u901f\u63d0\u4ea4\u4e00\u7ebf\u53cd\u9988\u4e0e\u75db\u70b9\uff0c\u7f29\u77ed\u9700\u6c42\u53d1\u73b0\u5468\u671f\uff0c\u4f46\u7f3a\u4e4f\u5bf9\u7ed3\u6784\u5316\u533b\u7597\u6570\u636e\u5b57\u6bb5\u7684\u5f3a\u5236\u6821\u9a8c\u80fd\u529b\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u533b\u7597\u5065\u5eb7\u521d\u521b\u56e2\u961f\u7684\u975e\u6838\u5fc3\u4e1a\u52a1\u6d41\u7a0b\u4f18\u5316\u3001\u5065\u5eb7\u79d1\u666e\u7c7bApp\u7684\u8f7b\u91cf\u7ea7\u8fed\u4ee3\uff0c\u4ee5\u53ca\u9662\u5185\u975e\u6d89\u89c4\u884c\u653f\u534f\u4f5c\u9879\u76ee\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5b66\u4e60\u6210\u672c\u6781\u4f4e\uff0c\u90e8\u7f72\u654f\u6377\uff0c\u80fd\u8fc5\u901f\u62c9\u901a\u4e34\u5e8a\u4e0e\u5f00\u53d1\u56e2\u961f\u7684\u6c9f\u901a\u58c1\u5792\uff1b\u4f46\u5728\u9762\u5bf9\u5f3a\u76d1\u7ba1\u3001\u9ad8\u8ffd\u6eaf\u8981\u6c42\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u9700\u6c42\u7ba1\u7406\u65f6\uff0c\u5b58\u5728\u672c\u8d28\u7684\u5408\u89c4\u77ed\u677f\u3002\u9009\u578b\u4eba\u5458\u9700\u660e\u786e\uff1a\u82e5\u9879\u76ee\u6d89\u53ca\u6838\u5fc3\u533b\u7597\u5408\u89c4\uff0cTower\u4ec5\u53ef\u4f5c\u4e3a\u524d\u7aef\u9700\u6c42\u6536\u96c6\u6c60\uff0c\u5fc5\u987b\u642d\u914d\u4e13\u4e1a\u9700\u6c42\u7ba1\u7406\u5de5\u5177\u4f7f\u7528\uff0c\u5207\u5fcc\u5c06\u5176\u4f5c\u4e3a\u6d89\u89c4\u7cfb\u7edf\u7684\u4e3b\u6570\u636e\u6e90\u3002<\/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\u654f\u6377\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0cJira\u57282026\u5e74\u4f9d\u7136\u662f\u4f17\u591a\u7814\u53d1\u56e2\u961f\u7684\u57fa\u7840\u8bbe\u65bd\u3002\u7136\u800c\uff0c\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u8fd9\u4e00\u5f3a\u5408\u89c4\u3001\u91cd\u8ffd\u6eaf\u7684\u7279\u5b9a\u9886\u57df\uff0c\u5176\u539f\u751f\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u5b58\u5728\u660e\u663e\u7ed3\u6784\u6027\u7f3a\u53e3\uff0c\u9700\u4f9d\u8d56\u6df1\u5ea6\u5b9a\u5236\u6216\u751f\u6001\u63d2\u4ef6\u8865\u9f50\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u5408\u89c4\u8ffd\u6eaf\u94fe\u6784\u5efa\uff1a<\/strong>\u539f\u751f\u4ec5\u63d0\u4f9bIssue\u7ea7\u5173\u8054\uff0c\u65e0\u6cd5\u76f4\u63a5\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u5bf9\u9700\u6c42-\u4ee3\u7801-\u6d4b\u8bd5\u7aef\u5230\u7aef\u53cc\u5411\u8ffd\u6eaf\u7684\u5f3a\u5236\u8981\u6c42\uff0c\u5fc5\u987b\u5f15\u5165\u63d2\u4ef6\uff08\u5982Xray\u6216Helix ALM\u96c6\u6210\uff09\u65b9\u80fd\u5efa\u7acb\u5408\u89c4\u8bc1\u636e\u94fe\u3002<\/li>\n<li><strong>\u9700\u6c42\u57fa\u7ebf\u4e0e\u53d8\u66f4\u63a7\u5236\uff1a<\/strong>\u539f\u751f\u7f3a\u4e4f\u4e25\u683c\u7684\u9700\u6c42\u57fa\u7ebf\u9501\u5b9a\u4e0e\u5ba1\u6279\u6d41\uff0c\u533b\u7597\u4ea7\u54c1\u9700\u6c42\u53d8\u66f4\u9700\u7ecf\u4e25\u82db\u8bc4\u5ba1\uff0cJira\u9700\u901a\u8fc7\u5b9a\u5236\u5316\u5de5\u4f5c\u6d41\u4e0e\u6743\u9650\u77e9\u9635\u52c9\u5f3a\u5b9e\u73b0\uff0c\u914d\u7f6e\u6210\u672c\u8f83\u9ad8\u3002<\/li>\n<li><strong>\u98ce\u9669\u4e0e\u5408\u89c4\u8054\u52a8\uff1a<\/strong>\u5bf9\u533b\u7597\u884c\u4e1a\u81f3\u5173\u91cd\u8981\u7684FMEA\u4e0e\u9700\u6c42\u8054\u52a8\uff0cJira\u539f\u751f\u65e0\u89e3\uff0c\u9700\u5efa\u7acb\u72ec\u7acbIssue\u7c7b\u578b\u5e76\u5f3a\u5173\u8054\uff0c\u6570\u636e\u5b64\u5c9b\u98ce\u9669\u5927\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u533b\u7597\u4e92\u8054\u7f51\u4ea7\u54c1\u6216\u8f7b\u91cf\u7ea7\u5065\u5eb7SaaS\u7684\u654f\u6377\u7814\u53d1\u8fed\u4ee3\uff1b\u4e0d\u9002\u7528\u4e8e\u690d\u5165\u6027\u533b\u7597\u5668\u68b0\u6216\u6838\u5fc3\u8bca\u7597\u7cfb\u7edf\u7b49\u5f3a\u5408\u89c4\u8f6f\u4ef6\u7684\u72ec\u7acb\u9700\u6c42\u7ba1\u63a7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u654f\u6377\u7ba1\u7406\u751f\u6001\u6781\u5ea6\u7e41\u8363\uff0c\u4e0eCI\/CD\u5de5\u5177\u94fe\u96c6\u6210\u65e0\u7f1d\uff0c\u5f00\u53d1\u8005\u63a5\u53d7\u5ea6\u6781\u9ad8\uff0c\u63d2\u4ef6\u5e02\u573a\u80fd\u63d0\u4f9b\u5408\u89c4\u8865\u6551\u65b9\u6848\u3002<\/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\u4ece\u9700\u6c42\u89c4\u5212\u5230\u4ee3\u7801\u90e8\u7f72\u7684\u5168\u94fe\u8def\u80fd\u529b\uff0c\u5728\u533b\u7597\u7814\u53d1\u4f53\u7cfb\u4e2d\u5177\u5907\u6df1\u539a\u7684\u751f\u6001\u57fa\u7840\u4e0e\u5408\u89c4\u6f5c\u529b\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027\u6784\u5efa\uff1a<\/strong>\u901a\u8fc7Work Item\u5c42\u7ea7\u5173\u8054\uff0c\u5b9e\u73b0\u4ece\u5408\u89c4\u9700\u6c42\u3001\u8bbe\u8ba1\u89c4\u683c\u5230\u4ee3\u7801\u63d0\u4ea4\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u5bf9\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u786c\u6027\u8981\u6c42\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u6743\u9650\u4e0e\u5ba1\u8ba1\u7ba1\u63a7\uff1a<\/strong>\u7ec6\u7c92\u5ea6\u7684\u6743\u9650\u77e9\u9635\u4e0e\u539f\u751f\u5ba1\u8ba1\u65e5\u5fd7\uff0c\u786e\u4fdd\u654f\u611f\u533b\u7597\u6570\u636e\u5728\u9700\u6c42\u6d41\u8f6c\u4e2d\u7684\u64cd\u4f5c\u5408\u89c4\u4e0e\u9632\u7be1\u6539\uff0c\u964d\u4f4e\u6570\u636e\u6cc4\u9732\u98ce\u9669\u3002<\/li>\n<li><strong>\u5408\u89c4\u751f\u6001\u65e0\u7f1d\u96c6\u6210\uff1a<\/strong>\u539f\u751f\u5bf9\u63a5Azure\u4e91\u5b89\u5168\u4e0e\u5408\u89c4\u8ba4\u8bc1\u4f53\u7cfb\uff0c\u5e76\u53ef\u901a\u8fc7\u6269\u5c55\u5e02\u573a\u96c6\u6210\u9759\u6001\u4ee3\u7801\u5206\u6790\u7b49\u533b\u7597\u4e13\u7528\u9a8c\u8bc1\u5de5\u5177\uff0c\u6784\u5efa\u95ed\u73af\u7684\u5408\u89c4\u4ea4\u4ed8\u6d41\u6c34\u7ebf\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u4ee5\u5fae\u8f6f\u6280\u672f\u6808\u4e3a\u4e3b\u3001\u9700\u6ee1\u8db3\u4e25\u82db\u533b\u7597\u5408\u89c4\u5ba1\u8ba1\u4e14\u7814\u53d1\u56e2\u961f\u89c4\u6a21\u8f83\u5927\u7684\u4f01\u4e1a\uff0c\u5c24\u5176\u662f\u6d89\u53ca\u533b\u7597\u5668\u68b0\u8f6f\u4ef6(SaMD)\u7684\u4e91\u539f\u751f\u7814\u53d1\u4f53\u7cfb\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5ba1\u8ba1\u65e5\u5fd7\u4e0e\u6743\u9650\u4f53\u7cfb\u6781\u5176\u4e25\u5bc6\uff1b\u5168\u94fe\u8def\u8ffd\u6eaf\u80fd\u529b\u6210\u719f\uff1b\u4e0eAzure\u4e91\u53ca\u4f01\u4e1aAD\u8d26\u53f7\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u5b89\u5168\u57fa\u7ebf\u6781\u9ad8\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_RM\"><\/span>Helix RM<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Helix RM \u662f Perforce \u65d7\u4e0b\u4e13\u6ce8\u4e8e\u9700\u6c42\u5b9a\u4e49\u4e0e\u8ffd\u6eaf\u7684\u4e13\u4e1a\u7ea7\u5de5\u5177\uff0c\u4ee5\u4e25\u5bc6\u7684\u7aef\u5230\u7aef\u8ffd\u6eaf\u6027\u4e0e\u5408\u89c4\u6027\u7ba1\u63a7\u89c1\u957f\uff0c\u5728\u5f3a\u76d1\u7ba1\u9886\u57df\u6df1\u8015\u591a\u5e74\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u5168\u751f\u547d\u5468\u671f\u7aef\u5230\u7aef\u8ffd\u6eaf\uff1a<\/strong>\u63d0\u4f9b\u4ece\u9ad8\u5c42\u4e1a\u52a1\u9700\u6c42\u5230\u7cfb\u7edf\u3001\u8f6f\u4ef6\u53ca\u6d4b\u8bd5\u7528\u4f8b\u7684\u65e0\u7f1d\u53cc\u5411\u8ffd\u6eaf\u94fe\u8def\uff0c\u7cbe\u51c6\u6ee1\u8db3\u533b\u7597\u8bbe\u5907\u7814\u53d1\u4e2dFDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u7684\u4e25\u82db\u5ba1\u67e5\u8981\u6c42\u3002<\/li>\n<li><strong>\u5408\u89c4\u57fa\u7ebf\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u5185\u7f6e\u7b26\u5408\u533b\u7597\u884c\u4e1a\u89c4\u8303\u7684\u57fa\u7ebf\u7ba1\u7406\uff0c\u6240\u6709\u9700\u6c42\u53d8\u66f4\u5747\u5e26\u4e0d\u53ef\u7be1\u6539\u7684\u6570\u5b57\u7b7e\u540d\u4e0e\u5b8c\u6574\u5ba1\u8ba1\u65e5\u5fd7\uff0c\u786e\u4fdd\u5408\u89c4\u4ea4\u4ed8\u8fc7\u7a0b\u65e0\u6b7b\u89d2\u3002<\/li>\n<li><strong>\u98ce\u9669\u4e0e\u9700\u6c42\u6df1\u5ea6\u8054\u52a8\uff1a<\/strong>\u652f\u6301\u5c06FMEA\u7b49\u98ce\u9669\u5206\u6790\u6761\u76ee\u76f4\u63a5\u5173\u8054\u81f3\u5177\u4f53\u9700\u6c42\uff0c\u5b9e\u73b0\u98ce\u9669\u63a7\u5236\u4e0e\u9700\u6c42\u5b9a\u4e49\u7684\u53cc\u5411\u9a8c\u8bc1\uff0c\u4ece\u6e90\u5934\u4fdd\u969c\u533b\u7597\u4ea7\u54c1\u5b89\u5168\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u3001\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\uff08IVD\uff09\u7b49\u5f3a\u5408\u89c4\u3001\u9ad8\u5b89\u5168\u98ce\u9669\u4ea7\u54c1\u7684\u8f6f\u786c\u4ef6\u7814\u53d1\u4e0e\u5408\u89c4\u7533\u62a5\u573a\u666f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5408\u89c4\u903b\u8f91\u6781\u5176\u4e25\u5bc6\uff0c\u8ffd\u6eaf\u77e9\u9635\u81ea\u52a8\u5316\u751f\u6210\u80fd\u529b\u5927\u5e45\u7f29\u51cf\u5ba1\u8ba1\u51c6\u5907\u5468\u671f\u3002\u5ba2\u89c2\u8bc4\u4f30\uff1a\u5176\u4ea4\u4e92\u4f53\u9a8c\u504f\u4f20\u7edf\uff0c\u5b66\u4e60\u95e8\u69db\u9ad8\uff0c\u4e14\u5bf9\u654f\u6377\u5f00\u53d1\u652f\u6301\u8f83\u5f31\u3002\u82e5\u56e2\u961f\u6838\u5fc3\u75db\u70b9\u662f\u5e94\u5bf9\u4e25\u82db\u7684\u5408\u89c4\u5ba1\u8ba1\uff0cHelix RM \u662f\u503c\u5f97\u5c1d\u8bd5\u7684\u5229\u5668\uff1b\u82e5\u4fa7\u91cd\u8f7b\u91cf\u7ea7\u654f\u6377\u8fed\u4ee3\uff0c\u5219\u9700\u8c28\u614e\u8003\u91cf\u5176\u5f15\u5165\u6210\u672c\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Visure_Requirements\"><\/span>Visure Requirements<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Visure Requirements\u662f\u6df1\u8015\u4e8e\u5b89\u5168\u82db\u6c42\u578b\u884c\u4e1a\u7684\u4e13\u4e1a\u9700\u6c42\u7ba1\u7406\u5e73\u53f0\uff0c\u5728\u533b\u7597\u8bbe\u5907\u4e0e\u4f53\u5916\u8bca\u65ad\u9886\u57df\u62e5\u6709\u6df1\u539a\u7684\u884c\u4e1a\u5b9e\u8df5\u79ef\u7d2f\uff0c\u5176\u8bbe\u8ba1\u903b\u8f91\u9ad8\u5ea6\u5951\u5408FDA 21 CFR Part 820\u4e0eIEC 62304\u7b49\u5408\u89c4\u6846\u67b6\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u94fe\u6784\u5efa\uff1a<\/strong>\u652f\u6301\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u5230\u8f6f\u4ef6\u8bbe\u8ba1\u3001\u6d4b\u8bd5\u7528\u4f8b\u53ca\u98ce\u9669\u63a7\u5236\u9879\u7684\u53cc\u5411\u5168\u94fe\u8def\u8ffd\u6eaf\uff0c\u786e\u4fdd\u5ba1\u8ba1\u8bc1\u636e\u94fe\u7684\u5b8c\u6574\u95ed\u73af\uff0c\u76f4\u51fb\u533b\u7597\u884c\u4e1a\u5ba1\u67e5\u75db\u70b9\u3002<\/li>\n<li><strong>\u9700\u6c42\u4e0e\u98ce\u9669\u6df1\u5ea6\u8026\u5408\uff1a<\/strong>\u5185\u7f6e\u98ce\u9669\u7ba1\u63a7\u6a21\u5757\uff0c\u652f\u6301FMEA\u4e0eFTA\u5206\u6790\u6761\u76ee\u4e0e\u5177\u4f53\u9700\u6c42\u7684\u52a8\u6001\u5173\u8054\uff0c\u5b9e\u73b0\u9700\u6c42\u53d8\u66f4\u5bf9\u7cfb\u7edf\u98ce\u9669\u5f71\u54cd\u7684\u5b9e\u65f6\u8bc4\u4f30\uff0c\u6ee1\u8db3ISO 14971\u5408\u89c4\u8981\u6c42\u3002<\/li>\n<li><strong>\u5408\u89c4\u6587\u6863\u81ea\u52a8\u5316\u8f93\u51fa\uff1a<\/strong>\u9884\u7f6e\u533b\u7597\u884c\u4e1a\u6a21\u677f\uff0c\u4e00\u952e\u751f\u6210\u7b26\u5408FDA\u4e0eCE\u8ba4\u8bc1\u8981\u6c42\u7684\u9a8c\u8bc1\u786e\u8ba4\u62a5\u544a\u53ca\u9700\u6c42\u8ffd\u8e2a\u77e9\u9635\uff08RTM\uff09\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u7533\u62a5\u7684\u6587\u6863\u7f16\u5236\u6210\u672c\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u533b\u7597\u5668\u68b0\u8f6f\u786c\u4ef6\u7814\u53d1\u3001\u53d7FDA\u6216MDR\u4e25\u683c\u76d1\u7ba1\u7684\u751f\u547d\u79d1\u5b66\u9879\u76ee\uff0c\u4ee5\u53ca\u9700\u8981\u5e94\u5bf9\u9ad8\u9891\u6b21\u4e25\u683c\u5ba1\u8ba1\u7684\u5408\u89c4\u9a71\u52a8\u578b\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5728\u533b\u7597\u5408\u89c4\u4e0e\u5ba1\u8ba1\u8ffd\u6eaf\u7ef4\u5ea6\u5177\u5907\u65e0\u53ef\u66ff\u4ee3\u7684\u4e13\u4e1a\u6df1\u5ea6\u3002\u4f46\u9700\u5ba2\u89c2\u8bc4\u4f30\uff0c\u5176UI\u4ea4\u4e92\u4e0e\u654f\u6377\u534f\u4f5c\u4f53\u9a8c\u504f\u4f20\u7edf\uff0c\u5bf9\u975e\u5b89\u5168\u82db\u6c42\u578b\u6216\u7eaf\u4e92\u8054\u7f51\u533b\u7597\u9879\u76ee\u800c\u8a00\u8fc7\u4e8e\u7b28\u91cd\u3002\u82e5\u56e2\u961f\u6838\u5fc3\u8bc9\u6c42\u662f\u201c\u901a\u8fc7\u4e25\u82db\u5ba1\u8ba1\u201d\uff0cVisure\u662f\u503c\u5f97\u6295\u5165\u7684\u5229\u5668\uff1b\u82e5\u4fa7\u91cd\u8f7b\u91cf\u7ea7\u8fed\u4ee3\uff0c\u5219\u9700\u8c28\u614e\u8bc4\u4f30\u5176\u5f15\u5165\u6210\u672c\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E5%B7%A5%E5%85%B7%E4%BD%BF%E7%94%A8%E5%BB%BA%E8%AE%AE%E4%B8%8E2026%E5%B9%B4%E9%80%89%E5%9E%8B%E6%80%BB%E7%BB%93\"><\/span>\u5de5\u5177\u4f7f\u7528\u5efa\u8bae\u4e0e2026\u5e74\u9009\u578b\u603b\u7ed3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9488\u5bf9\u4e0d\u540c\u89c4\u6a21\u4e0e\u4e1a\u52a1\u5f62\u6001\u7684\u533b\u7597\u5065\u5eb7\u7ec4\u7ec7\uff0c\u6211\u4eec\u63d0\u51fa\u4ee5\u4e0b\u5de5\u5177\u4f7f\u7528\u5efa\u8bae\uff1a\u5bf9\u4e8e\u7814\u53d1\u9ad8\u7b49\u7ea7\u533b\u7597\u5668\u68b0\u4e14\u9762\u4e34\u6781\u4e25\u5408\u89c4\u538b\u529b\u7684\u4f01\u4e1a\uff0c\u5efa\u8bae\u4f18\u5148\u8bc4\u4f30Helix RM\u4e0eVisure Requirements\uff0c\u5b83\u4eec\u7684\u4e13\u4e1a\u8ffd\u6eaf\u80fd\u529b\u80fd\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u6210\u672c\uff1b\u5bf9\u4e8e\u8ffd\u6c42\u654f\u6377\u4ea4\u4ed8\u4e14\u5177\u5907\u4e00\u5b9a\u5b9a\u5236\u80fd\u529b\u7684\u533b\u7597SaaS\u56e2\u961f\uff0cJira\u4e0eAzure DevOps\u662f\u6784\u5efa\u7814\u53d1\u5de5\u7a0b\u4f53\u7cfb\u7684\u6709\u529b\u652f\u6491\uff1b\u800c\u5bf9\u4e8e\u6ce8\u91cd\u6570\u636e\u4e3b\u6743\u3001\u9700\u8981\u4e00\u4f53\u5316\u7ba1\u7406\u5e73\u53f0\u7684\u5927\u578b\u533b\u7597\u96c6\u56e2\uff0cONES\u7684\u672c\u5730\u5316\u4e0e\u7efc\u5408\u7ba1\u7406\u80fd\u529b\u66f4\u4e3a\u5951\u5408\uff1bTower\u5219\u66f4\u9002\u5b9c\u5c0f\u578b\u56e2\u961f\u6216\u4f5c\u4e3a\u4e1a\u52a1\u4fa7\u7684\u9700\u6c42\u8f7b\u6536\u96c6\u5165\u53e3\u3002<\/p>\n<p>\u7efc\u4e0a\u6240\u8ff0\uff0c2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u7684\u9009\u578b\uff0c\u672c\u8d28\u4e0a\u662f\u5728\u5408\u89c4\u7ba1\u63a7\u4e0e\u654f\u6377\u4ea4\u4ed8\u4e4b\u95f4\u5bfb\u627e\u6700\u4f18\u89e3\u3002\u660e\u786e\u81ea\u8eab\u7684\u4e1a\u52a1\u8fb9\u754c\u3001\u5408\u89c4\u57fa\u7ebf\u4e0e\u56e2\u961f\u73b0\u72b6\uff0c\u624d\u80fd\u5728\u4f17\u591a\u5de5\u5177\u4e2d\u7b5b\u9009\u51fa\u771f\u6b63\u503c\u5f97\u5c1d\u8bd5\u7684\u5229\u5668\uff0c\u8ba9\u9700\u6c42\u7ba1\u7406\u6210\u4e3a\u533b\u7597\u4ea7\u54c1\u521b\u65b0\u7684\u5b89\u5168\u5e95\u5ea7\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%E5%9C%A8%E9%80%89%E6%8B%A9%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%97%B6%EF%BC%8C%E6%9C%80%E5%BA%94%E4%BC%98%E5%85%88%E8%80%83%E8%99%91%E4%BB%80%E4%B9%88%E8%83%BD%E5%8A%9B%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u5728\u9009\u62e9\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u65f6\uff0c\u6700\u5e94\u4f18\u5148\u8003\u8651\u4ec0\u4e48\u80fd\u529b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6700\u5e94\u4f18\u5148\u8003\u8651\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b\u3002\u533b\u7597\u884c\u4e1a\u6d89\u53ca\u60a3\u8005\u5b89\u5168\u4e0e\u9690\u79c1\uff0c\u7cfb\u7edf\u5fc5\u987b\u652f\u6301\u7aef\u5230\u7aef\u7684\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff08RTM\uff09\u4ee5\u53ca\u7b26\u5408FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u7684\u7535\u5b50\u7b7e\u540d\u548c\u5ba1\u8ba1\u65e5\u5fd7\u529f\u80fd\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E6%98%AF%E5%90%A6%E9%80%82%E5%90%88%E7%94%A8%E4%BA%8E%E9%9C%80%E8%A6%81%E4%B8%A5%E6%A0%BC%E5%90%88%E8%A7%84%E7%9A%84%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E8%BD%AF%E4%BB%B6%E7%A0%94%E5%8F%91%EF%BC%9F\"><\/span>Jira\u662f\u5426\u9002\u5408\u7528\u4e8e\u9700\u8981\u4e25\u683c\u5408\u89c4\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Jira\u539f\u751f\u66f4\u504f\u5411\u654f\u6377\u9879\u76ee\u7ba1\u7406\uff0c\u82e5\u7528\u4e8e\u4e25\u683c\u5408\u89c4\u7684\u533b\u7597\u5668\u68b0\u7814\u53d1\uff0c\u9700\u914d\u5408\u5408\u89c4\u7c7b\u63d2\u4ef6\uff08\u5982Xray\u7b49\uff09\u8fdb\u884c\u6df1\u5ea6\u5b9a\u5236\uff0c\u4ee5\u6784\u5efa\u7b26\u5408IEC 62304\u6807\u51c6\u7684\u8ffd\u6eaf\u94fe\u8def\uff0c\u914d\u7f6e\u6210\u672c\u76f8\u5bf9\u8f83\u9ad8\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E4%B8%BA%E4%BB%80%E4%B9%88Helix_RM%E5%92%8CVisure_Requirements%E5%B8%B8%E8%A2%AB%E6%8E%A8%E8%8D%90%E7%BB%99%E7%94%9F%E5%91%BD%E7%A7%91%E5%AD%A6%E9%A2%86%E5%9F%9F%EF%BC%9F\"><\/span>\u4e3a\u4ec0\u4e48Helix RM\u548cVisure Requirements\u5e38\u88ab\u63a8\u8350\u7ed9\u751f\u547d\u79d1\u5b66\u9886\u57df\uff1f<span 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