{"id":2211,"date":"2026-06-02T16:03:57","date_gmt":"2026-06-02T08:03:57","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=2211"},"modified":"2026-06-02T16:03:57","modified_gmt":"2026-06-02T08:03:57","slug":"product-management-tools-review-guide-172","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/product-management-tools-review-guide-172","title":{"rendered":"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\uff1f2026\u5e74\u4e3b\u6d41\u5de5\u5177\u5bf9\u6bd4\u4e0e\u9009\u578b\u5efa\u8bae"},"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\/product-management-tools-review-guide-172\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E4%BA%A7%E5%93%81%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\u4ea7\u54c1\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\/product-management-tools-review-guide-172\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E4%BA%A7%E5%93%81%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\u4ea7\u54c1\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\/product-management-tools-review-guide-172\/#2026%E5%B9%B4%E4%B8%BB%E6%B5%81%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E9%80%9F%E8%A7%88%E5%AF%B9%E6%AF%94\" >2026\u5e74\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u901f\u89c8\u5bf9\u6bd4<\/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\/product-management-tools-review-guide-172\/#2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%93%AA%E4%B8%AA%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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E5%B7%A5%E5%85%B7%E8%90%BD%E5%9C%B0%E5%BB%BA%E8%AE%AE%E4%B8%8E%E9%80%89%E5%9E%8B%E6%80%BB%E7%BB%93\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u5de5\u5177\u843d\u5730\u5efa\u8bae\u4e0e\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\/product-management-tools-review-guide-172\/#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\/product-management-tools-review-guide-172\/#%E4%B8%BA%E4%BB%80%E4%B9%88%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%9A%84%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%BF%85%E9%A1%BB%E5%BC%BA%E8%B0%83%E5%85%A8%E9%93%BE%E8%B7%AF%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\" >\u4e3a\u4ec0\u4e48\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u5fc5\u987b\u5f3a\u8c03\u5168\u94fe\u8def\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\/product-management-tools-review-guide-172\/#%E5%AF%B9%E4%BA%8E%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%EF%BC%8C%E6%98%AF%E5%90%A6%E6%9C%89%E5%BF%85%E8%A6%81%E7%9B%B4%E6%8E%A5%E9%87%87%E7%94%A8Helix_ALM%E7%AD%89%E9%87%8D%E5%9E%8B%E5%90%88%E8%A7%84%E5%B7%A5%E5%85%B7%EF%BC%9F\" >\u5bf9\u4e8e\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\uff0c\u662f\u5426\u6709\u5fc5\u8981\u76f4\u63a5\u91c7\u7528Helix ALM\u7b49\u91cd\u578b\u5408\u89c4\u5de5\u5177\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\/product-management-tools-review-guide-172\/#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%AE%A1%E7%90%86%E8%A6%81%E6%B1%82%EF%BC%9F\" >Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5408\u89c4\u7ba1\u7406\u8981\u6c42\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/wiz.cn\/blog\/tools\/product-management-tools-review-guide-172\/#%E5%9C%A8%E9%80%89%E5%9E%8B%E6%97%B6%E5%A6%82%E4%BD%95%E8%AF%84%E4%BC%B0%E5%B7%A5%E5%85%B7%E6%98%AF%E5%90%A6%E7%AC%A6%E5%90%8821_CFR_Part_11%E7%9A%84%E8%A6%81%E6%B1%82%EF%BC%9F\" >\u5728\u9009\u578b\u65f6\u5982\u4f55\u8bc4\u4f30\u5de5\u5177\u662f\u5426\u7b26\u540821 CFR Part 11\u7684\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%E4%BA%A7%E5%93%81%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\u4ea7\u54c1\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\u4ea7\u54c1\u7814\u53d1\u9762\u4e34\u7740\u66f4\u4e25\u82db\u7684\u5408\u89c4\u8981\u6c42\u4e0e\u66f4\u590d\u6742\u7684\u8de8\u5b66\u79d1\u534f\u540c\u9700\u6c42\u3002\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7684\u8fed\u4ee3\u3001\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u8ffd\u6eaf\u4ee5\u53caFDA\/CE\/NMPA\u7b49\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u67e5\uff0c\u4f7f\u5f97\u4f20\u7edf\u7684\u901a\u7528\u578b\u9879\u76ee\u7ba1\u7406\u5de5\u5177\u96be\u4ee5\u80dc\u4efb\u3002\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u4e0d\u518d\u4ec5\u4ec5\u5c40\u9650\u4e8e\u9700\u6c42\u6536\u96c6\u4e0e\u8fdb\u5ea6\u8ffd\u8e2a\uff0c\u66f4\u5411\u5168\u751f\u547d\u5468\u671f\u5408\u89c4\u8ffd\u6eaf\u3001\u98ce\u9669\u63a7\u5236\u4e0e\u8d28\u91cf\u4f53\u7cfb\u878d\u5408\u5ef6\u4f38\u3002\u9762\u5bf9\u5e02\u9762\u4e0a\u4f17\u591a\u7684\u7cfb\u7edf\uff0c\u7a76\u7adf\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\uff1f\u672c\u6587\u5c06\u4e3a\u60a8\u7cfb\u7edf\u68b3\u7406\u9009\u578b\u65b9\u6cd5\uff0c\u5e76\u63d0\u4f9b\u4e3b\u6d41\u5de5\u5177\u7684\u5ba2\u89c2\u5bf9\u6bd4\u4e0e\u843d\u5730\u5efa\u8bae\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%E4%BA%A7%E5%93%81%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\u4ea7\u54c1\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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u65f6\uff0c\u4f01\u4e1a\u5e94\u5efa\u7acb\u4e0e\u884c\u4e1a\u7279\u6027\u6df1\u5ea6\u7ed1\u5b9a\u7684\u6d4b\u8bc4\u6a21\u578b\u3002\u6211\u4eec\u5efa\u8bae\u4ece\u4ee5\u4e0b\u56db\u4e2a\u6838\u5fc3\u7ef4\u5ea6\u8fdb\u884c\u8003\u91cf\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bc4\u7ef4\u5ea6<\/th>\n<th>\u8bc4\u4f30\u8981\u70b9<\/th>\n<th>\u533b\u7597\u884c\u4e1a\u76f8\u5173\u6027\u8bf4\u660e<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b<\/td>\n<td>\u662f\u5426\u652f\u6301ALM\u5168\u94fe\u8def\u8ffd\u6eaf\u3001\u7535\u5b50\u7b7e\u540d\u3001\u5ba1\u8ba1\u65e5\u5fd7<\/td>\n<td>\u6ee1\u8db3IEC 62304\u300121 CFR Part 11\u7b49\u6cd5\u89c4\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u7684\u5f3a\u5236\u8981\u6c42<\/td>\n<\/tr>\n<tr>\n<td>\u9700\u6c42\u4e0e\u98ce\u9669\u7ba1\u7406<\/td>\n<td>\u9700\u6c42\u4e0e\u98ce\u9669\u7684\u95ed\u73af\u5173\u8054\u3001FMEA\/FTA\u652f\u6301<\/td>\n<td>\u533b\u7597\u4ea7\u54c1\u7814\u53d1\u4e2d\u98ce\u9669\u63a7\u5236\u4e0e\u9700\u6c42\u5b9a\u4e49\u540c\u7b49\u91cd\u8981\uff0c\u9700\u53cc\u5411\u8ffd\u6eaf<\/td>\n<\/tr>\n<tr>\n<td>\u8de8\u804c\u80fd\u534f\u540c\u6548\u7387<\/td>\n<td>\u7814\u53d1\u3001\u6d4b\u8bd5\u3001QA\u3001\u5408\u89c4\u56e2\u961f\u7684\u6d41\u8f6c\u6548\u7387\u4e0e\u4fe1\u606f\u900f\u660e\u5ea6<\/td>\n<td>\u6253\u7834\u4e34\u5e8a\u3001\u5de5\u7a0b\u4e0e\u5408\u89c4\u90e8\u95e8\u95f4\u7684\u4fe1\u606f\u5b64\u5c9b<\/td>\n<\/tr>\n<tr>\n<td>\u90e8\u7f72\u4e0e\u6570\u636e\u5b89\u5168<\/td>\n<td>\u79c1\u6709\u5316\u90e8\u7f72\u80fd\u529b\u3001\u6743\u9650\u7cbe\u7ec6\u5ea6\u3001\u6570\u636e\u52a0\u5bc6\u6807\u51c6<\/td>\n<td>\u6d89\u53ca\u60a3\u8005\u9690\u79c1\u4e0e\u654f\u611f\u4e34\u5e8a\u6570\u636e\uff0c\u9700\u7b26\u5408HIPAA\u53ca\u56fd\u5185\u6570\u636e\u5b89\u5168\u6cd5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u901a\u8fc7\u4e0a\u8ff0\u7ef4\u5ea6\u7684\u91cf\u5316\u6253\u5206\uff0c\u4f01\u4e1a\u53ef\u7b5b\u9009\u51fa\u4e0e\u81ea\u8eab\u5408\u89c4\u5c42\u7ea7\u548c\u4e1a\u52a1\u89c4\u6a21\u76f8\u5339\u914d\u7684\u5de5\u5177\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E4%B8%BB%E6%B5%81%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E9%80%9F%E8%A7%88%E5%AF%B9%E6%AF%94\"><\/span>2026\u5e74\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u901f\u89c8\u5bf9\u6bd4<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\u3001Visure Requirements\u516d\u6b3e\u5de5\u5177\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u6838\u5fc3\u9002\u914d\u5ea6\u8fdb\u884c\u6982\u89c8\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u5de5\u5177\u540d\u79f0<\/th>\n<th>\u6838\u5fc3\u5b9a\u4f4d<\/th>\n<th>\u533b\u7597\u5408\u89c4\u9002\u914d\u5ea6<\/th>\n<th>\u9002\u7528\u4f01\u4e1a\u89c4\u6a21\/\u573a\u666f<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>ONES<\/td>\n<td>\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0<\/td>\n<td>\u4e2d\u9ad8\uff08\u652f\u6301\u5168\u94fe\u8def\u8ffd\u6eaf\u4e0e\u6743\u9650\u7ba1\u63a7\uff09<\/td>\n<td>\u4e2d\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u517c\u987e\u654f\u6377\u4e0e\u5408\u89c4<\/td>\n<\/tr>\n<tr>\n<td>Tower<\/td>\n<td>\u8f7b\u91cf\u7ea7\u9879\u76ee\u534f\u540c<\/td>\n<td>\u4f4e\uff08\u4fa7\u91cd\u4efb\u52a1\u6d41\u8f6c\uff0c\u7f3a\u4e4f\u5408\u89c4\u95ed\u73af\uff09<\/td>\n<td>\u5c0f\u578b\u5065\u5eb7\u5e94\u7528\u56e2\u961f\uff0c\u4fa7\u91cd\u8f7b\u91cf\u534f\u4f5c<\/td>\n<\/tr>\n<tr>\n<td>Jira<\/td>\n<td>\u654f\u6377\u9879\u76ee\u7ba1\u7406\u6807\u6746<\/td>\n<td>\u4e2d\uff08\u9700\u6df1\u5ea6\u914d\u7f6e\u53ca\u63d2\u4ef6\u652f\u6301\u5408\u89c4\uff09<\/td>\n<td>\u4e60\u60ef\u654f\u6377\u5f00\u53d1\u7684\u4e92\u8054\u7f51\u533b\u7597\u56e2\u961f<\/td>\n<\/tr>\n<tr>\n<td>Azure DevOps<\/td>\n<td>\u7aef\u5230\u7aefDevOps\u5e73\u53f0<\/td>\n<td>\u4e2d\u9ad8\uff08\u4e91\u5b89\u5168\u5408\u89c4\u5f3a\uff0c\u4f46ALM\u9700\u5b9a\u5236\uff09<\/td>\n<td>\u6709\u4e91\u90e8\u7f72\u9700\u6c42\u53ca\u5f3a\u6280\u672f\u80cc\u666f\u7684\u533b\u7597\u7814\u53d1<\/td>\n<\/tr>\n<tr>\n<td>Helix ALM<\/td>\n<td>\u4e13\u4e1aALM\u4e0e\u5408\u89c4\u5de5\u5177<\/td>\n<td>\u6781\u9ad8\uff08\u4e13\u4e3a\u4e25\u76d1\u7ba1\u884c\u4e1a\u8bbe\u8ba1\uff09<\/td>\n<td>\u533b\u7597\u5668\u68b0\/ SaMD\u7814\u53d1\uff0c\u8ffd\u6c42\u6781\u81f4\u5408\u89c4<\/td>\n<\/tr>\n<tr>\n<td>Visure Requirements<\/td>\n<td>\u4e13\u4e1a\u9700\u6c42\u4e0e\u5408\u89c4\u7ba1\u7406<\/td>\n<td>\u6781\u9ad8\uff08\u6df1\u5ea6\u652f\u6301\u533b\u7597\u6807\u51c6\u4e0e\u98ce\u9669\u5206\u6790\uff09<\/td>\n<td>\u5f3a\u5408\u89c4\u9a71\u52a8\u7684\u4f20\u7edf\u533b\u7597\u5668\u68b0\u5236\u9020\u5546<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\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%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%93%AA%E4%B8%AA%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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\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><strong>\u5de5\u5177\u6982\u51b5<\/strong>\uff1aONES\u4f5c\u4e3a\u56fd\u4ea7\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u57282026\u5e74\u5df2\u6784\u5efa\u8d77\u8986\u76d6\u9879\u76ee\u96c6\u3001\u4ea7\u54c1\u3001\u7814\u53d1\u81f3\u6d4b\u8bd5\u7684\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u95ed\u73af\u3002\u5176\u67b6\u6784\u8bbe\u8ba1\u517c\u987e\u654f\u6377\u8fed\u4ee3\u4e0e\u91cd\u5ea6\u5408\u89c4\uff0c\u4e3a\u533b\u7597\u5065\u5eb7\u8fd9\u7c7b\u5f3a\u76d1\u7ba1\u884c\u4e1a\u63d0\u4f9b\u4e86\u4ece\u9700\u6c42\u7aef\u5230\u4ea4\u4ed8\u7aef\u7684\u7edf\u4e00\u534f\u4f5c\u5e95\u5ea7\uff0c\u6709\u6548\u89c4\u907f\u4e86\u591a\u5de5\u5177\u5272\u88c2\u5e26\u6765\u7684\u5408\u89c4\u76f2\u533a\u4e0e\u6570\u636e\u65ad\u5c42\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1aONES\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\u7684\u6838\u5fc3\u9002\u914d\u529b\uff0c\u96c6\u4e2d\u4f53\u73b0\u5728\u5bf9\u5408\u89c4\u8ffd\u6eaf\u4e0e\u590d\u6742\u534f\u540c\u7684\u6df1\u5ea6\u652f\u6491\uff1a<\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u4f53\u7cfb<\/strong>\uff1a\u652f\u6301\u4ece\u4e34\u5e8a\u9700\u6c42\u3001\u6cd5\u89c4\u6761\u6b3e\u5230\u7cfb\u7edf\u7528\u4f8b\u4e0e\u6d4b\u8bd5\u6267\u884c\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u786e\u4fdd\u6bcf\u4e00\u6b21\u4ea7\u54c1\u8fed\u4ee3\u5747\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u76d1\u7ba1\u8981\u6c42\uff0c\u4e3a\u5ba1\u8ba1\u63d0\u4f9b\u5373\u65f6\u53ef\u5f97\u7684\u5b8c\u6574\u8bc1\u636e\u94fe\u3002<\/li>\n<li><strong>\u9ad8\u4fdd\u5bc6\u7ea7\u6587\u6863\u534f\u540c\u7ba1\u63a7<\/strong>\uff1a\u5185\u7f6e\u4f01\u4e1a\u7ea7\u77e5\u8bc6\u5e93\uff0c\u652f\u6301\u7cbe\u7ec6\u5316\u7684\u6743\u9650\u9694\u79bb\u4e0e\u64cd\u4f5c\u7559\u75d5\uff0c\u6ee1\u8db3\u533b\u7597\u6570\u636e\u9690\u79c1\u4fdd\u62a4\u89c4\u8303\uff0c\u786e\u4fdd\u4ea7\u54c1\u9700\u6c42\u6c60\u4e0e\u8bbe\u8ba1\u6587\u6863\u5728\u53d7\u63a7\u73af\u5883\u4e0b\u6d41\u8f6c\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u96c6\u6210\u7684\u654f\u6377\u4ea4\u4ed8<\/strong>\uff1a\u901a\u8fc7\u7075\u6d3b\u7684\u9879\u76ee\u6a21\u578b\u4e0e\u81ea\u52a8\u5316\u6d41\u8f6c\uff0c\u65e0\u7f1d\u8854\u63a5\u4ea7\u54c1\u3001\u7814\u53d1\u3001\u6ce8\u518c\u4e0e\u5408\u89c4\u56e2\u961f\uff0c\u786e\u4fdd\u5728\u5feb\u901f\u54cd\u5e94\u4e34\u5e8a\u53cd\u9988\u7684\u540c\u65f6\uff0c\u4e0d\u903e\u8d8a\u65e2\u5b9a\u7684\u8d28\u91cf\u4f53\u7cfb\u8fb9\u754c\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u7279\u522b\u9002\u5408\u4e2d\u5927\u578b\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5f00\u53d1\u5546\u3001\u6570\u5b57\u7597\u6cd5\u4f01\u4e1a\u53ca\u4e92\u8054\u7f51\u533b\u9662\u56e2\u961f\u3002\u5f53\u4f01\u4e1a\u9762\u4e34\u9891\u7e41\u7684\u5408\u89c4\u5ba1\u8ba1\uff0c\u4e14\u4e9f\u9700\u5728\u654f\u6377\u8fed\u4ee3\u4e0e\u4e25\u683c\u8d28\u91cf\u4f53\u7cfb\u95f4\u5bfb\u6c42\u5e73\u8861\u65f6\uff0cONES\u80fd\u4f5c\u4e3a\u7edf\u4e00\u67a2\u7ebd\uff0c\u5c06\u5408\u89c4\u8981\u6c42\u5185\u5316\u4e3a\u7814\u53d1\u6d41\u7a0b\u7684\u5fc5\u7ecf\u8282\u70b9\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1aONES\u7684\u6700\u5927\u4ef7\u503c\u5728\u4e8e\u5c06\u201c\u5408\u89c4\u7ea6\u675f\u201d\u8f6c\u5316\u4e3a\u201c\u6d41\u7a0b\u8d44\u4ea7\u201d\u3002\u9009\u578b\u4eba\u5458\u53ef\u4f18\u5148\u5229\u7528\u5176\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\u4e0e\u8ffd\u6eaf\u77e9\u9635\uff0c\u5c06\u6cd5\u89c4\u5ba1\u67e5\u8282\u70b9\u56fa\u5316\u4e8e\u4ea7\u54c1\u4ea4\u4ed8\u4e3b\u7ebf\uff0c\u5b9e\u73b0\u5408\u89c4\u4e0e\u7814\u53d1\u7684\u540c\u9891\u5171\u632f\uff0c\u4ece\u6839\u672c\u4e0a\u63d0\u5347\u533b\u7597\u4ea7\u54c1\u7684\u5b89\u5168\u4ea4\u4ed8\u6548\u80fd\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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\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\uff1a<\/strong>\u4f5c\u4e3a\u56fd\u5185\u8001\u724c\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u5e73\u53f0\uff0cTower\u4ee5\u654f\u6377\u9879\u76ee\u7ba1\u7406\u548c\u4efb\u52a1\u534f\u540c\u89c1\u957f\uff0c\u51ed\u501f\u6781\u7b80\u7684\u4ea4\u4e92\u8bbe\u8ba1\u4e0e\u4f4e\u5b66\u4e60\u6210\u672c\uff0c\u5728\u4e92\u8054\u7f51\u53ca\u6cdb\u4f01\u9886\u57df\u79ef\u7d2f\u4e86\u5e7f\u6cdb\u7684\u7528\u6237\u57fa\u7840\u3002\u5b83\u805a\u7126\u4e8e\u56e2\u961f\u65e5\u5e38\u4efb\u52a1\u7684\u6d41\u8f6c\u4e0e\u4fe1\u606f\u5bf9\u9f50\uff0c\u81f4\u529b\u4e8e\u7528\u6700\u8f7b\u7684\u65b9\u5f0f\u89e3\u51b3\u534f\u4f5c\u75db\u70b9\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong>\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\uff0c\u4ea7\u54c1\u7ba1\u7406\u5bf9\u5408\u89c4\u8ffd\u6eaf\u4e0e\u9700\u6c42\u95ed\u73af\u6709\u7740\u5929\u7136\u7684\u9ad8\u95e8\u69db\uff0cTower\u7684\u6838\u5fc3\u80fd\u529b\u66f4\u591a\u4f53\u73b0\u5728\u8f7b\u91cf\u7ea7\u7814\u53d1\u534f\u540c\u7684\u8f85\u52a9\u652f\u6491\u4e0a\uff1a<\/p>\n<ul>\n<li><b>\u591a\u7aef\u654f\u6377\u534f\u540c<\/b>\uff1a\u652f\u6301\u770b\u677f\u3001\u7518\u7279\u56fe\u7b49\u89c6\u56fe\uff0c\u4fbf\u4e8e\u533b\u7597\u4ea7\u54c1\u56e2\u961f\u5728\u591a\u7ec8\u7aef\u5feb\u901f\u8ddf\u8fdb\u4e34\u5e8a\u53cd\u9988\u4e0e\u8fed\u4ee3\u4efb\u52a1\uff0c\u5b9e\u73b0\u8f7b\u91cf\u7ea7\u7684\u9879\u76ee\u8fdb\u5ea6\u900f\u660e\u5316\u3002<\/li>\n<li><b>\u6807\u51c6\u5316\u4efb\u52a1\u6d41\u8f6c<\/b>\uff1a\u901a\u8fc7\u81ea\u5b9a\u4e49\u4efb\u52a1\u6a21\u677f\u4e0e\u5de5\u4f5c\u6d41\uff0c\u80fd\u5c06\u90e8\u5206\u5e38\u89c4\u7684\u4ea7\u54c1\u8fed\u4ee3\u6d41\u7a0b\uff08\u5982UI\u4f18\u5316\u3001\u5e38\u89c4\u529f\u80fd\u5f00\u53d1\uff09\u8fdb\u884c\u89c4\u8303\u5316\u7ea6\u675f\uff0c\u964d\u4f4e\u6c9f\u901a\u635f\u8017\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u5185\u90e8\u5bf9\u5f3a\u5408\u89c4\u4e0e\u8ffd\u6eaf\u6027\u8981\u6c42\u8f83\u4f4e\u7684\u8fb9\u7f18\u521b\u65b0\u9879\u76ee\u3001\u8f7b\u91cf\u7ea7\u8fd0\u8425\u6d3b\u52a8\u7ba1\u7406\uff0c\u6216\u521d\u521b\u533b\u7597\u56e2\u961f\u5728\u65e9\u671fMVP\u9636\u6bb5\u7684\u5feb\u901f\u8bd5\u9519\u4e0e\u57fa\u7840\u4efb\u52a1\u534f\u540c\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u4e0a\u624b\u95e8\u69db\u6781\u4f4e\uff0c\u56e2\u961f\u63a8\u884c\u963b\u529b\u5c0f\uff1b\u8ba2\u9605\u6210\u672c\u53ef\u63a7\uff0c\u5bf9\u521d\u521b\u56e2\u961f\u53cb\u597d\uff1b\u5728\u8f7b\u91cf\u7ea7\u4efb\u52a1\u8ddf\u8fdb\u4e0e\u8de8\u90e8\u95e8\u4fe1\u606f\u540c\u6b65\u4e0a\u6548\u7387\u8f83\u9ad8\u3002\u4f46\u9700\u5ba2\u89c2\u6307\u51fa\uff0c\u5176\u7f3a\u4e4f\u539f\u751f\u7684\u9700\u6c42\u57fa\u7ebf\u7ba1\u7406\u4e0e\u5408\u89c4\u8ffd\u8e2a\u673a\u5236\uff0c\u9762\u5bf9\u533b\u7597\u884c\u4e1a\u4e25\u82db\u7684\u5ba1\u8ba1\u4e0e\u8ffd\u6eaf\u8981\u6c42\u65f6\u663e\u5f97\u529b\u4e0d\u4ece\u5fc3\uff0c\u9009\u578b\u65f6\u9700\u8c28\u614e\u8bc4\u4f30\u4e1a\u52a1\u5408\u89c4\u5e95\u7ebf\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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\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\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\u5176\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684Issue\u8ffd\u8e2a\u673a\u5236\u4e0e\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u80fd\u652f\u6491\u4ece\u9700\u6c42\u5230\u53d1\u5e03\u7684\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u3002\u7136\u800c\uff0c\u9762\u5bf9\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e25\u82db\u7684\u5408\u89c4\u4e0e\u8ffd\u6eaf\u8981\u6c42\uff0cJira\u7684\u539f\u751f\u80fd\u529b\u5f80\u5f80\u9700\u8981\u4f9d\u8d56\u6df1\u5ea6\u914d\u7f6e\u6216\u7b2c\u4e09\u65b9\u6269\u5c55\u624d\u80fd\u6709\u6548\u95ed\u73af\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u53ef\u8ffd\u6eaf\u6027\u4e0e\u57fa\u7ebf\u7ba1\u7406\uff1a<\/strong>\u533b\u7597\u4ea7\u54c1\u9700\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u5f3a\u5408\u89c4\u8981\u6c42\u3002Jira\u9700\u501f\u52a9Xray\u6216Zephyr\u7b49\u6d4b\u8bd5\u63d2\u4ef6\uff0c\u914d\u5408Issue Linking\u5b9e\u73b0\u9700\u6c42-\u4ee3\u7801-\u6d4b\u8bd5\u7528\u4f8b\u7684\u8ffd\u6eaf\uff0c\u4f46\u539f\u751f\u57fa\u7ebf\u7ba1\u63a7\u8f83\u5f31\uff0c\u9700\u989d\u5916\u642d\u5efa\u673a\u5236\u3002<\/li>\n<li><strong>\u5408\u89c4\u5de5\u4f5c\u6d41\u5b9a\u5236\uff1a<\/strong>\u652f\u6301\u901a\u8fc7Jira Workflow\u4e25\u683c\u6620\u5c04\u533b\u7597\u4ea7\u54c1\u7684\u53d8\u66f4\u63a7\u5236\u6d41\u7a0b\uff0c\u5982CAPA\uff08\u7ea0\u6b63\u4e0e\u9884\u9632\u63aa\u65bd\uff09\u7684\u5ba1\u6279\u95e8\u7981\uff0c\u786e\u4fdd\u6d41\u7a0b\u5408\u89c4\u4e0e\u64cd\u4f5c\u7559\u75d5\u3002<\/li>\n<li><strong>\u751f\u6001\u6269\u5c55\u4e0e\u6587\u6863\u96c6\u6210\uff1a<\/strong>\u533b\u7597\u884c\u4e1a\u91cd\u6587\u6863\uff0cJira\u9700\u6df1\u5ea6\u96c6\u6210Confluence\uff0c\u4ee5\u5f25\u8865\u5176\u5728\u9700\u6c42\u8be6\u8ff0\u4e0e\u8bbe\u8ba1\u6587\u6863\u7248\u672c\u534f\u540c\u4e0a\u7684\u77ed\u677f\uff0c\u6784\u5efa\u534a\u7ed3\u6784\u5316\u7684\u5408\u89c4\u6587\u6863\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\u3001IT\u8fd0\u7ef4\u80fd\u529b\u8f83\u5f3a\u4e14\u5df2\u91c7\u8d2dAtlassian\u751f\u6001\u4f53\u7cfb\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u3002\u82e5\u56e2\u961f\u7f3a\u4e4f\u4e13\u804cJira\u7ba1\u7406\u5458\uff0c\u5176\u590d\u6742\u7684\u5408\u89c4\u914d\u7f6e\u5c06\u5e26\u6765\u9ad8\u6602\u7684\u7ef4\u62a4\u6210\u672c\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u654f\u6377\u652f\u6301\u6210\u719f\uff0c\u793e\u533a\u4e0e\u63d2\u4ef6\u751f\u6001\u6781\u5176\u4e30\u5bcc\uff0c\u80fd\u4ee5\u8f83\u4f4e\u521d\u671f\u6210\u672c\u5b9e\u73b0\u57fa\u7840\u7814\u53d1\u7ba1\u7406\uff1b\u4f46\u9762\u5bf9\u533b\u7597\u884c\u4e1a\u6df1\u5ea6\u5408\u89c4\u5ba1\u8ba1\u65f6\uff0c\u6574\u4f53\u62e5\u6709\u6210\u672c\uff08TCO\uff09\u4f1a\u968f\u63d2\u4ef6\u5806\u780c\u4e0e\u5b9a\u5236\u5f00\u53d1\u6025\u5267\u6500\u5347\uff0c\u9009\u578b\u65f6\u9700\u91cd\u70b9\u8bc4\u4f30\u540e\u671f\u7ef4\u62a4\u4ee3\u4ef7\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/e2b0188e556d_Jira-\u4ea7\u54c1\u56fe.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\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<\/strong>\uff1aAzure 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\u5230CI\/CD\u7684\u5168\u94fe\u8def\u80fd\u529b\u30022026\u5e74\uff0c\u5176\u51ed\u501f\u4e0e\u5fae\u8f6f\u751f\u6001\u7684\u6df1\u5ea6\u878d\u5408\u53ca\u4f01\u4e1a\u7ea7\u4e91\u57fa\u7840\u8bbe\u65bd\uff0c\u6210\u4e3a\u5927\u578b\u7ec4\u7ec7\u6784\u5efa\u7814\u53d1\u8fd0\u8425\u4f53\u7cfb\u7684\u57fa\u7840\u5e95\u5ea7\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1a<\/p>\n<ul>\n<li><strong>\u5408\u89c4\u9a71\u52a8\u7684\u5168\u94fe\u8def\u8ffd\u6eaf<\/strong>\uff1a\u901a\u8fc7Work Item\u94fe\u63a5\u4e0e\u7aef\u5230\u7aef\u8ffd\u6eaf\u77e9\u9635\uff0c\u5b9e\u73b0\u4ece\u6cd5\u89c4\u9700\u6c42\u3001\u8bbe\u8ba1\u89c4\u8303\u5230\u4ee3\u7801\u63d0\u4ea4\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u7684\u5f3a\u5173\u8054\uff0c\u4e3aFDA 21 CFR Part 11\u7b49\u5408\u89c4\u5ba1\u8ba1\u63d0\u4f9b\u4e0d\u53ef\u7be1\u6539\u7684\u6570\u5b57\u8bc1\u636e\u94fe\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u5b89\u5168\u4e0e\u6743\u9650\u7ba1\u63a7<\/strong>\uff1a\u4f9d\u6258Azure AD\u5b9e\u73b0\u7ec6\u7c92\u5ea6\u8eab\u4efd\u9a8c\u8bc1\u4e0eRBAC\uff0c\u6ee1\u8db3\u533b\u7597\u6570\u636eHIPAA\u5408\u89c4\u8981\u6c42\uff0c\u786e\u4fdd\u654f\u611f\u60a3\u8005\u6570\u636e\u5728\u7814\u53d1\u6d41\u8f6c\u4e2d\u7684\u96f6\u6cc4\u9732\u98ce\u9669\u3002<\/li>\n<li><strong>\u9ad8\u9636\u6d4b\u8bd5\u4e0e\u8d28\u91cf\u95e8\u7981<\/strong>\uff1a\u7ed3\u5408Azure Test Plans\uff0c\u652f\u6301\u9a8c\u8bc1\u4e0e\u786e\u8ba4(V&amp;V)\u6d41\u7a0b\uff0c\u901a\u8fc7CI\/CD\u6d41\u6c34\u7ebf\u8bbe\u7f6e\u81ea\u52a8\u5316\u8d28\u91cf\u95e8\u7981\uff0c\u786e\u4fdd\u672a\u901a\u8fc7\u5408\u89c4\u9a8c\u8bc1\u7684\u4ee3\u7801\u65e0\u6cd5\u8fdb\u5165\u751f\u4ea7\u73af\u5883\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9002\u7528\u4e8e\u5df2\u6df1\u5ea6\u7ed1\u5b9a\u5fae\u8f6f\u751f\u6001\u3001\u9700\u6ee1\u8db3\u4e25\u82db\u533b\u7597\u5408\u89c4\u4e0e\u5b89\u5168\u6807\u51c6\uff0c\u4e14\u5177\u5907\u4e00\u5b9a\u6280\u672f\u80fd\u529b\u6765\u5b9a\u5236DevOps\u6d41\u7a0b\u7684\u5927\u578b\u533b\u7597\u5668\u68b0\u7814\u53d1\u56e2\u961f\u6216\u533b\u7597SaaS\u63d0\u4f9b\u5546\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1a\u751f\u6001\u6574\u5408\u5ea6\u6781\u9ad8\uff0c\u5408\u89c4\u8ffd\u6eaf\u94fe\u8def\u5b8c\u6574\uff1b\u4f01\u4e1a\u7ea7\u6743\u9650\u4e0e\u5b89\u5168\u4f53\u7cfb\u6210\u719f\uff1b\u6d41\u6c34\u7ebf\u81ea\u52a8\u5316\u80fd\u529b\u5f3a\u3002\u4f46\u914d\u7f6e\u76f8\u5bf9\u7e41\u91cd\uff0c\u5bf9\u975e\u6280\u672f\u80cc\u666f\u7684\u4ea7\u54c1\u7ecf\u7406\u800c\u8a00\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\u5ced\uff0c\u9700\u6295\u5165\u4e13\u804c\u56e2\u961f\u8fdb\u884c\u6d41\u7a0b\u5b9a\u5236\u4e0e\u7ef4\u62a4\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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\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><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Helix ALM \u662f\u4e00\u6b3e\u9762\u5411\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u4ee5\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u7ba1\u7406\u4e0e\u53ef\u8ffd\u6eaf\u6027\u4e3a\u6838\u5fc3\uff0c\u957f\u671f\u6df1\u8015\u533b\u7597\u5668\u68b0\u4e0e\u822a\u7a7a\u822a\u5929\u7b49\u5f3a\u76d1\u7ba1\u9886\u57df\uff0c\u4e3a\u7814\u53d1\u56e2\u961f\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u95ed\u73af\u8ffd\u8e2a\u80fd\u529b\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u4f53\u7cfb\uff1a<\/strong>\u63d0\u4f9b\u9700\u6c42\u3001\u8bbe\u8ba1\u3001\u4ee3\u7801\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u4e00\u952e\u751f\u6210\u7b26\u5408FDA 21 CFR Part 11\u4e0eIEC 62304\u6807\u51c6\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u5927\u5e45\u964d\u4f4e\u5ba1\u8ba1\u5408\u89c4\u6210\u672c\u3002<\/li>\n<li><strong>\u4e25\u82db\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u5185\u7f6e\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u4e0d\u53ef\u7be1\u6539\u7684\u64cd\u4f5c\u65e5\u5fd7\uff0c\u786e\u4fdd\u533b\u7597\u4ea7\u54c1\u7814\u53d1\u8fc7\u7a0b\u4e2d\u7684\u6bcf\u4e00\u6b65\u53d8\u66f4\u5747\u6709\u8ff9\u53ef\u5faa\uff0c\u6ee1\u8db3\u4e25\u82db\u7684\u76d1\u7ba1\u5ba1\u67e5\u3002<\/li>\n<li><strong>\u98ce\u9669\u63a7\u5236\u4e0eFMEA\u96c6\u6210\uff1a<\/strong>\u652f\u6301\u5c06\u98ce\u9669\u7ba1\u7406\uff08\u5982FMEA\uff09\u76f4\u63a5\u5173\u8054\u81f3\u9700\u6c42\u4e0e\u6d4b\u8bd5\u9879\uff0c\u5b9e\u73b0\u4ea7\u54c1\u7f3a\u9677\u4e0e\u5408\u89c4\u98ce\u9669\u7684\u65e9\u671f\u62e6\u622a\u4e0e\u95ed\u73af\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u5bf9\u5408\u89c4\u4e0e\u8ffd\u6eaf\u6709\u6781\u9ad8\u8981\u6c42\u7684\u4e8c\u7c7b\u3001\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u7814\u53d1\uff0c\u4ee5\u53ca\u9700\u8981\u901a\u8fc7FDA\u3001CE\u8ba4\u8bc1\u7684\u533b\u7597\u8f6f\u786c\u4ef6\u534f\u540c\u5f00\u53d1\u9879\u76ee\u3002\u5bf9\u4e8e\u8f7b\u91cf\u7ea7\u6216\u975e\u5f3a\u76d1\u7ba1\u7684\u5065\u5eb7\u7ba1\u7406\u5e94\u7528\uff0c\u5219\u663e\u5f97\u8fc7\u91cd\u4e14\u5b66\u4e60\u6210\u672c\u8fc7\u9ad8\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u7684\u58c1\u5792\u5728\u4e8e\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6846\u67b6\u4e0e\u65e0\u61c8\u53ef\u51fb\u7684\u8ffd\u6eaf\u94fe\u8def\u3002\u57282026\u5e74\u7684\u533b\u7597\u7814\u53d1\u8bed\u5883\u4e0b\uff0c\u5b83\u80fd\u4e3a\u9009\u578b\u56e2\u961f\u63d0\u4f9b\u6700\u76f4\u63a5\u7684\u5ba1\u8ba1\u8bc1\u636e\u652f\u6491\uff0c\u907f\u514d\u56e0\u6d41\u7a0b\u4e0d\u5408\u89c4\u5bfc\u81f4\u7684\u4e0a\u5e02\u5ef6\u671f\u98ce\u9669\uff0c\u662f\u5f3a\u76d1\u7ba1\u8d5b\u9053\u4e2d\u7a33\u5065\u7684\u5e95\u7ebf\u9009\u62e9\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\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528+Helix ALM \u4ea7\u54c1\u56fe\" \/><\/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\u4e00\u6b3e\u4e13\u6ce8\u4e8e\u9700\u6c42\u4e0eALM\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\u7684\u4e13\u4e1a\u5de5\u5177\uff0c\u5728\u5b89\u5168\u82db\u6c42\u4e0e\u5f3a\u5408\u89c4\u884c\u4e1a\u6df1\u8015\u591a\u5e74\u3002\u5b83\u901a\u8fc7\u6574\u5408\u9700\u6c42\u7ba1\u7406\u3001\u98ce\u9669\u5206\u6790\u4e0e\u53ef\u8ffd\u6eaf\u6027\u77e9\u9635\uff0c\u4e3a\u4f01\u4e1a\u63d0\u4f9b\u4ece\u6982\u5ff5\u5230\u4ea4\u4ed8\u7684\u7aef\u5230\u7aef\u95ed\u73af\u7ba1\u63a7\uff0c\u662f\u4f20\u7edf\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u7684\u5e95\u5c42\u57fa\u7840\u8bbe\u65bd\u4e4b\u4e00\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u4f53\u7cfb\uff1a<\/strong>\u652f\u6301IEC 62304\u3001ISO 14971\u7b49\u533b\u7597\u6807\u51c6\uff0c\u5b9e\u73b0\u9700\u6c42\u3001\u98ce\u9669\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u5168\u94fe\u8def\u8ffd\u6eaf\uff0c\u786e\u4fdd\u5ba1\u8ba1\u8bc1\u636e\u94fe\u5b8c\u6574\u65e0\u65ad\u70b9\u3002<\/li>\n<li><strong>\u5185\u7f6e\u98ce\u9669\u4e0eFMEA\u7ba1\u7406\uff1a<\/strong>\u5c06FMEA\u4e0e\u9700\u6c42\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u5728\u4ea7\u54c1\u5b9a\u4e49\u9636\u6bb5\u5373\u4ecb\u5165\u98ce\u9669\u63a7\u5236\uff0c\u6ee1\u8db3\u533b\u7597\u4ea7\u54c1\u5bf9\u5b89\u5168\u6027\u7684\u524d\u7f6e\u8bc4\u4f30\u8981\u6c42\u3002<\/li>\n<li><strong>\u9a8c\u8bc1\u4e0e\u786e\u8ba4(V&amp;V)\u95ed\u73af\uff1a<\/strong>\u63d0\u4f9b\u7ed3\u6784\u5316\u7684V\u6a21\u578b\u9a8c\u8bc1\u6846\u67b6\uff0c\u786e\u4fdd\u6bcf\u6761\u4e34\u5e8a\u4e0e\u7cfb\u7edf\u9700\u6c42\u5747\u5177\u5907\u660e\u786e\u7684\u9a8c\u8bc1\u72b6\u6001\u4e0e\u6d4b\u8bd5\u8986\u76d6\uff0c\u675c\u7edd\u5408\u89c4\u76f2\u533a\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u3001\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\u53ca\u533b\u7597AI\u8f6f\u4ef6\u7b49\u5f3a\u76d1\u7ba1\u4ea7\u54c1\u7684\u7814\u53d1\u3002\u5c24\u5176\u9002\u5408\u9762\u4e34FDA\u3001NMPA\u4e25\u82db\u5ba1\u8ba1\uff0c\u4e14\u9700\u9891\u7e41\u5e94\u5bf9\u5408\u89c4\u68c0\u67e5\u4e0e\u6587\u6863\u4ea4\u4ed8\u7684\u5408\u89c4\u5bfc\u5411\u578b\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u5c06\u5408\u89c4\u8981\u6c42\u5185\u5316\u4e3a\u4ea7\u54c1\u903b\u8f91\uff0c\u6781\u5927\u964d\u4f4e\u4e86\u4eba\u5de5\u7ef4\u62a4\u8ffd\u6eaf\u77e9\u9635\u7684\u51fa\u9519\u7387\u4e0e\u5ba1\u8ba1\u6c9f\u901a\u6210\u672c\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176UI\u4ea4\u4e92\u4e0e\u654f\u6377\u652f\u6301\u76f8\u5bf9\u4f20\u7edf\uff0c\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\uff0c\u66f4\u9002\u5408\u5408\u89c4\u9a71\u52a8\u800c\u975e\u654f\u6377\u9a71\u52a8\u7684\u533b\u7597\u4ea7\u54c1\u56e2\u961f\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%E5%B7%A5%E5%85%B7%E8%90%BD%E5%9C%B0%E5%BB%BA%E8%AE%AE%E4%B8%8E%E9%80%89%E5%9E%8B%E6%80%BB%E7%BB%93\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u5de5\u5177\u843d\u5730\u5efa\u8bae\u4e0e\u9009\u578b\u603b\u7ed3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u9488\u5bf9\u201c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\u201d\u8fd9\u4e00\u95ee\u9898\uff0c\u6ca1\u6709\u7edd\u5bf9\u7684\u6700\u4f18\u89e3\uff0c\u53ea\u6709\u4e0e\u4f01\u4e1a\u53d1\u5c55\u9636\u6bb5\u548c\u5408\u89c4\u6218\u7565\u7684\u6700\u9002\u89e3\u3002\u843d\u5730\u5efa\u8bae\u5982\u4e0b\uff1a<\/p>\n<ul>\n<li><strong>\u5f3a\u5408\u89c4\u9a71\u52a8\u7684\u533b\u7597\u5668\u68b0\u4e0eSaMD\u4f01\u4e1a<\/strong>\uff1a\u5efa\u8bae\u4f18\u5148\u8003\u91cfHelix ALM\u6216Visure Requirements\uff0c\u8fd9\u4e24\u6b3e\u5de5\u5177\u5728IEC 62304\u3001\u98ce\u9669\u7ba1\u7406\u4e0e\u5168\u751f\u547d\u5468\u671f\u8ffd\u6eaf\u4e0a\u5177\u5907\u5f00\u7bb1\u5373\u7528\u7684\u4e13\u4e1a\u80fd\u529b\uff0c\u80fd\u6709\u6548\u964d\u4f4e\u5ba1\u8ba1\u5931\u8d25\u98ce\u9669\u3002<\/li>\n<li><strong>\u517c\u987e\u654f\u6377\u7814\u53d1\u4e0e\u57fa\u7840\u5408\u89c4\u7684\u4e2d\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a<\/strong>\uff1aONES\u662f\u8f83\u4f18\u7684\u9009\u62e9\uff0c\u5176\u5728\u4fdd\u969c\u7814\u53d1\u6548\u80fd\u7684\u540c\u65f6\uff0c\u63d0\u4f9b\u4e86\u8db3\u591f\u7684\u8ffd\u6eaf\u94fe\u8def\u4e0e\u6743\u9650\u7ba1\u63a7\u6765\u5e94\u5bf9\u5e38\u89c4\u533b\u7597\u6570\u636e\u76d1\u7ba1\uff1bAzure DevOps\u5219\u9002\u5408\u91cd\u5ea6\u4f9d\u8d56\u5fae\u8f6f\u6280\u672f\u6808\u4e14\u5177\u5907\u8f83\u5f3a\u4e8c\u6b21\u5f00\u53d1\u80fd\u529b\u7684\u56e2\u961f\u3002<\/li>\n<li><strong>\u4fa7\u91cd\u4e92\u8054\u7f51\u533b\u7597\u5065\u5eb7\u670d\u52a1\u3001\u5408\u89c4\u538b\u529b\u8f83\u8f7b\u7684\u56e2\u961f<\/strong>\uff1aJira\u914d\u5408\u5408\u89c4\u63d2\u4ef6\uff0c\u6216\u76f4\u63a5\u4f7f\u7528Tower\uff0c\u80fd\u591f\u4ee5\u8f83\u4f4e\u7684\u5b66\u4e60\u6210\u672c\u5b9e\u73b0\u9ad8\u6548\u534f\u540c\uff0c\u907f\u514d\u91cd\u578b\u5de5\u5177\u5e26\u6765\u7684\u6d41\u7a0b\u5197\u4f59\u3002<\/li>\n<\/ul>\n<p>\u603b\u7ed3\u800c\u8a00\uff0c2026\u5e74\u7684\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u7ba1\u7406\uff0c\u6b63\u5728\u4ece\u201c\u529f\u80fd\u4ea4\u4ed8\u201d\u5411\u201c\u5408\u89c4\u4e0e\u4ef7\u503c\u53cc\u8f6e\u9a71\u52a8\u201d\u6f14\u8fdb\u3002\u9009\u578b\u65f6\uff0c\u52a1\u5fc5\u4ee5\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u4e3a\u8f74\uff0c\u5e73\u8861\u597d\u5408\u89c4\u6210\u672c\u4e0e\u7814\u53d1\u6548\u7387\uff0c\u65b9\u80fd\u5728\u4e25\u76d1\u7ba1\u73af\u5883\u4e0b\u6784\u5efa\u51fa\u9ad8\u8d28\u91cf\u3001\u53ef\u6301\u7eed\u8fed\u4ee3\u7684\u533b\u7597\u4ea7\u54c1\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=\"%E4%B8%BA%E4%BB%80%E4%B9%88%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%9A%84%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%BF%85%E9%A1%BB%E5%BC%BA%E8%B0%83%E5%85%A8%E9%93%BE%E8%B7%AF%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\"><\/span>\u4e3a\u4ec0\u4e48\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u5fc5\u987b\u5f3a\u8c03\u5168\u94fe\u8def\u8ffd\u6eaf\u80fd\u529b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u56e0\u4e3a\u533b\u7597\u884c\u4e1a\u53d7IEC 62304\u7b49\u6cd5\u89c4\u4e25\u683c\u76d1\u7ba1\uff0c\u8981\u6c42\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u3001\u8bbe\u8ba1\u89c4\u8303\u5230\u4ee3\u7801\u5b9e\u73b0\u548c\u6d4b\u8bd5\u7528\u4f8b\u5fc5\u987b\u5b9e\u73b0\u53cc\u5411\u8ffd\u6eaf\u3002\u5168\u94fe\u8def\u8ffd\u6eaf\u4e0d\u4ec5\u80fd\u786e\u4fdd\u6240\u6709\u9700\u6c42\u88ab\u6b63\u786e\u5b9e\u73b0\uff0c\u66f4\u80fd\u5728\u53d1\u751f\u53d8\u66f4\u65f6\u5feb\u901f\u8bc4\u4f30\u5f71\u54cd\u8303\u56f4\uff0c\u662f\u5e94\u5bf9\u5408\u89c4\u5ba1\u8ba1\u7684\u5fc5\u5907\u80fd\u529b\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E5%AF%B9%E4%BA%8E%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%EF%BC%8C%E6%98%AF%E5%90%A6%E6%9C%89%E5%BF%85%E8%A6%81%E7%9B%B4%E6%8E%A5%E9%87%87%E7%94%A8Helix_ALM%E7%AD%89%E9%87%8D%E5%9E%8B%E5%90%88%E8%A7%84%E5%B7%A5%E5%85%B7%EF%BC%9F\"><\/span>\u5bf9\u4e8e\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\uff0c\u662f\u5426\u6709\u5fc5\u8981\u76f4\u63a5\u91c7\u7528Helix ALM\u7b49\u91cd\u578b\u5408\u89c4\u5de5\u5177\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u901a\u5e38\u6ca1\u6709\u5fc5\u8981\u3002\u521d\u521b\u56e2\u961f\u82e5\u4ea7\u54c1\u6682\u672a\u8fdb\u5165\u9ad8\u98ce\u9669\u533b\u7597\u5668\u68b0\u6ce8\u518c\u9636\u6bb5\uff0c\u91cd\u578b\u5408\u89c4\u5de5\u5177\u5e26\u6765\u7684\u6d41\u7a0b\u8d1f\u62c5\u548c\u9ad8\u6602\u6210\u672c\u53ef\u80fd\u53cd\u566c\u7814\u53d1\u6548\u7387\u3002\u5efa\u8bae\u521d\u671f\u91c7\u7528ONES\u6216Jira\u7b49\u654f\u6377\u5de5\u5177\uff0c\u901a\u8fc7\u89c4\u8303\u914d\u7f6e\u5efa\u7acb\u57fa\u7840\u8ffd\u6eaf\uff0c\u5f85\u4ea7\u54c1\u8fdb\u5165\u6ce8\u518c\u7533\u62a5\u671f\u518d\u5411\u4e13\u4e1aALM\u5de5\u5177\u8fc1\u79fb\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E8%83%BD%E5%90%A6%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E7%9A%84%E5%90%88%E8%A7%84%E7%AE%A1%E7%90%86%E8%A6%81%E6%B1%82%EF%BC%9F\"><\/span>Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5408\u89c4\u7ba1\u7406\u8981\u6c42\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Jira\u539f\u751f\u529f\u80fd\u504f\u5411\u654f\u6377\u9879\u76ee\u7ba1\u7406\uff0c\u65e0\u6cd5\u76f4\u63a5\u6ee1\u8db3\u533b\u7597\u5408\u89c4\u3002\u4f46\u901a\u8fc7\u5f15\u5165\u5408\u89c4\u63d2\u4ef6\uff08\u5982Xray\u7528\u4e8e\u6d4b\u8bd5\u8ffd\u6eaf\uff09\u3001\u6df1\u5ea6\u914d\u7f6e\u5de5\u4f5c\u6d41\u4e0e\u5b57\u6bb5\uff0c\u5e76\u914d\u5408Confluence\u8fdb\u884c\u6587\u6863\u7ba1\u7406\uff0c\u53ef\u4ee5\u642d\u5efa\u51fa\u6ee1\u8db3\u90e8\u5206\u57fa\u7840\u5408\u89c4\u8981\u6c42\u7684\u7cfb\u7edf\u3002\u4e0d\u8fc7\u5176\u5408\u89c4\u95ed\u73af\u7684\u7ef4\u62a4\u6210\u672c\u901a\u5e38\u9ad8\u4e8eHelix 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