{"id":2019,"date":"2026-06-04T10:13:17","date_gmt":"2026-06-04T02:13:17","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=2019"},"modified":"2026-06-04T10:13:17","modified_gmt":"2026-06-04T02:13:17","slug":"product-management-tools-guide-3","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/product-management-tools-guide-3","title":{"rendered":"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\uff1f2026\u4e3b\u6d41\u5de5\u5177\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\/product-management-tools-guide-3\/#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\" >2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7684\u65b0\u6311\u6218\u4e0e\u7834\u5c40<\/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-guide-3\/#%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%E6%A0%B8%E5%BF%83%E6%B5%8B%E8%AF%84%E7%BB%B4%E5%BA%A6%E8%A7%A3%E6%9E%90\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u6838\u5fc3\u6d4b\u8bc4\u7ef4\u5ea6\u89e3\u6790<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/wiz.cn\/blog\/tools\/product-management-tools-guide-3\/#2026%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%E6%A6%82%E8%A7%88\" >2026\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u6982\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\/product-management-tools-guide-3\/#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-guide-3\/#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-guide-3\/#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-guide-3\/#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-guide-3\/#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-guide-3\/#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-guide-3\/#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-guide-3\/#%E9%80%89%E5%9E%8B%E5%86%B3%E7%AD%96%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%9C%AA%E6%9D%A5%E5%B1%95%E6%9C%9B\" >\u9009\u578b\u51b3\u7b56\u5efa\u8bae\u4e0e\u672a\u6765\u5c55\u671b<\/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-guide-3\/#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-guide-3\/#%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%E5%BF%85%E9%A1%BB%E5%85%B3%E6%B3%A8%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%E5%90%88%E8%A7%84%E8%BF%BD%E6%BA%AF%E8%83%BD%E5%8A%9B%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u5fc5\u987b\u5173\u6ce8\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u7684\u5408\u89c4\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-guide-3\/#%E5%88%9D%E5%88%9B%E5%9E%8B%E6%95%B0%E5%AD%97%E5%81%A5%E5%BA%B7%E5%9B%A2%E9%98%9F%E5%BA%94%E8%AF%A5%E9%80%89%E6%8B%A9%E5%93%AA%E6%AC%BE%E5%B7%A5%E5%85%B7%EF%BC%9F\" >\u521d\u521b\u578b\u6570\u5b57\u5065\u5eb7\u56e2\u961f\u5e94\u8be5\u9009\u62e9\u54ea\u6b3e\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-guide-3\/#Jira%E8%83%BD%E5%90%A6%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E7%9A%84IEC_62304%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%EF%BC%9F\" >Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u884c\u4e1a\u7684IEC 62304\u5408\u89c4\u8981\u6c42\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/wiz.cn\/blog\/tools\/product-management-tools-guide-3\/#ONES%E5%9C%A8%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%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\" >ONES\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\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%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\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7684\u65b0\u6311\u6218\u4e0e\u7834\u5c40<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\u524d\u6240\u672a\u6709\u7684\u4e25\u82db\u73af\u5883\u3002\u4ece\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u7684\u5408\u89c4\u6027\u8981\u6c42\uff0c\u5230\u60a3\u8005\u6570\u636e\u9690\u79c1\u4fdd\u62a4\u7684\u5f3a\u76d1\u7ba1\uff0c\u518d\u5230\u8de8\u5b66\u79d1\u56e2\u961f\uff08\u4e34\u5e8a\u4e13\u5bb6\u3001\u6cd5\u89c4\u4e13\u5458\u3001\u7814\u53d1\u5de5\u7a0b\u5e08\uff09\u7684\u9ad8\u6548\u534f\u540c\uff0c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u4ea7\u54c1\u7ba1\u7406\u65e9\u5df2\u8d85\u8d8a\u4f20\u7edfIT\u9879\u76ee\u8303\u7574\u3002\u9762\u5bf9\u590d\u6742\u7684\u8ffd\u6eaf\u6027\u8981\u6c42\u548c\u4e25\u82db\u7684\u5ba1\u8ba1\u6807\u51c6\uff0c\u9009\u62e9\u4e00\u6b3e\u5951\u5408\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u80fd\u529b\u7684\u7cfb\u7edf\u81f3\u5173\u91cd\u8981\u3002\u7a76\u7adf\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\uff1f\u672c\u6587\u5c06\u4e3a\u60a8\u63d0\u4f9b\u4e00\u4efd\u6e05\u6670\u7684\u9009\u578b\u6307\u5357\u4e0e\u5b9e\u64cd\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%E6%A0%B8%E5%BF%83%E6%B5%8B%E8%AF%84%E7%BB%B4%E5%BA%A6%E8%A7%A3%E6%9E%90\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u6838\u5fc3\u6d4b\u8bc4\u7ef4\u5ea6\u89e3\u6790<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\u4e0d\u80fd\u4ec5\u505c\u7559\u5728\u5e38\u89c4\u7684\u4efb\u52a1\u6d41\u8f6c\u5c42\u9762\uff0c\u800c\u5e94\u56f4\u7ed5\u884c\u4e1a\u7279\u6709\u7684\u5408\u89c4\u4e0e\u534f\u540c\u8bc9\u6c42\u5efa\u7acb\u79d1\u5b66\u7684\u9009\u578b\u65b9\u6cd5\u3002\u4ee5\u4e0b\u4e3a\u672c\u6b21\u6d4b\u8bc4\u7684\u56db\u5927\u6838\u5fc3\u7ef4\u5ea6\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\u5173\u8054\u6027<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u5408\u89c4\u4e0e\u8ffd\u6eaf\u80fd\u529b<\/td>\n<td>\u9700\u6c42\u53cc\u5411\u8ffd\u6eaf\u3001\u7535\u5b50\u7b7e\u540d\u3001\u5ba1\u8ba1\u65e5\u5fd7\u3001IEC 62304\/FDA 21 CFR Part 11\u652f\u6301<\/td>\n<td>\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u4e0e\u6570\u5b57\u7597\u6cd5\u5f3a\u5408\u89c4\u5ba1\u8ba1\u8981\u6c42\uff0c\u907f\u514d\u5408\u89c4\u98ce\u9669<\/td>\n<\/tr>\n<tr>\n<td>\u8de8\u804c\u80fd\u534f\u540c\u6df1\u5ea6<\/td>\n<td>\u591a\u89d2\u8272\u89c6\u56fe\u3001\u8de8\u90e8\u95e8\u5de5\u4f5c\u6d41\u3001\u4e34\u5e8a\u53cd\u9988\u95ed\u73af<\/td>\n<td>\u6253\u901a\u4e34\u5e8a\u3001\u6cd5\u89c4\u4e0e\u7814\u53d1\u58c1\u5792\uff0c\u964d\u4f4e\u6c9f\u901a\u6210\u672c\u4e0e\u4fe1\u606f\u5dee<\/td>\n<\/tr>\n<tr>\n<td>\u654f\u6377\u4e0e\u6df7\u5408\u6a21\u5f0f\u652f\u6301<\/td>\n<td>Scrum\/Kanban\u652f\u6301\u3001\u4f20\u7edf\u7011\u5e03\u6d41\u517c\u5bb9\u3001\u6df7\u5408\u6a21\u578b\u5207\u6362<\/td>\n<td>\u9002\u5e94\u533b\u7597\u4ea7\u54c1\u4ece\u524d\u671f\u5408\u89c4\u7011\u5e03\u5230\u540e\u671f\u8fed\u4ee3\u654f\u6377\u7684\u6f14\u8fdb<\/td>\n<\/tr>\n<tr>\n<td>\u751f\u6001\u4e0e\u96c6\u6210\u80fd\u529b<\/td>\n<td>\u5f00\u653eAPI\u3001\u4e0eALM\/PLM\/\u6d4b\u8bd5\u5de5\u5177\u539f\u751f\u96c6\u6210<\/td>\n<td>\u5bf9\u63a5\u73b0\u6709\u533b\u7597IT\u7cfb\u7edf\uff0c\u5b9e\u73b0\u7aef\u5230\u7aef\u6570\u636e\u65e0\u635f\u6d41\u8f6c<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"2026%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%E6%A6%82%E8%A7%88\"><\/span>2026\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u6982\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\u516d\u6b3e\u4e3b\u6d41\u5de5\u5177\u7684\u6838\u5fc3\u5b9a\u4f4d\u4e0e\u533b\u7597\u884c\u4e1a\u9002\u914d\u5ea6\u8fdb\u884c\u5feb\u901f\u626b\u89c6\uff0c\u5e2e\u52a9\u60a8\u5efa\u7acb\u521d\u6b65\u8ba4\u77e5\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u4f01\u4e1a\u7ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u63d0\u4f9b\u5f3a\u5927\u7684\u9700\u6c42\u4e0e\u9879\u76ee\u7ba1\u7406\u80fd\u529b\uff0c\u5728\u6df7\u5408\u6a21\u578b\u4e0e\u8de8\u56e2\u961f\u534f\u540c\u4e0a\u8868\u73b0\u4f18\u5f02\uff0c\u9002\u5408\u4e2d\u578b\u81f3\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u8f7b\u91cf\u7ea7\u654f\u6377\u534f\u4f5c\u5de5\u5177\uff0c\u4ee5\u6613\u7528\u6027\u89c1\u957f\uff0c\u9002\u5408\u521d\u521b\u578b\u6570\u5b57\u5065\u5eb7\u56e2\u961f\u5feb\u901f\u843d\u5730\u654f\u6377\u5f00\u53d1\uff0c\u4f46\u5728\u6df1\u5ea6\u5408\u89c4\u8ffd\u6eaf\u4e0a\u9700\u8f85\u4ee5\u5176\u4ed6\u5de5\u5177\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u5168\u7403\u5e7f\u6cdb\u5e94\u7528\u7684\u654f\u6377\u9879\u76ee\u7ba1\u7406\u6807\u6746\uff0c\u751f\u6001\u6781\u5176\u4e30\u5bcc\uff0c\u901a\u8fc7\u63d2\u4ef6\u53ef\u6ee1\u8db3\u90e8\u5206\u8ffd\u6eaf\u9700\u6c42\uff0c\u9002\u5408\u7814\u53d1\u9a71\u52a8\u578b\u533b\u7597\u4e92\u8054\u7f51\u56e2\u961f\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u7cfb\u4e00\u7ad9\u5f0fDevOps\u5e73\u53f0\uff0c\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u4ee3\u7801\u5230\u90e8\u7f72\u7ba1\u7406\uff0c\u5728\u5927\u578b\u533b\u7597IT\u57fa\u7840\u8bbe\u65bd\u4e0e\u4e91\u539f\u751f\u5065\u5eb7\u5e94\u7528\u7814\u53d1\u4e2d\u5360\u636e\u4e3b\u5bfc\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e1a\u7ea7\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u4e13\u4e3a\u9ad8\u5408\u89c4\u884c\u4e1a\u8bbe\u8ba1\uff0c\u63d0\u4f9b\u5f00\u7bb1\u5373\u7528\u7684\u7aef\u5230\u7aef\u8ffd\u6eaf\u4e0e\u6d4b\u8bd5\u7ba1\u7406\uff0c\u662f\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\u7684\u91cd\u78c5\u5229\u5668\u3002<\/li>\n<li><strong>Visure Requirements<\/strong>\uff1a\u4e13\u6ce8\u4e8e\u9700\u6c42\u5de5\u7a0b\u4e0e\u5408\u89c4\u8ffd\u6eaf\u7684ALM\u5de5\u5177\uff0c\u6df1\u5ea6\u652f\u6301ISO 26262\u3001IEC 62304\u7b49\u6807\u51c6\uff0c\u9002\u5408\u5bf9\u9700\u6c42\u89c4\u8303\u4e0e\u5408\u89c4\u5ba1\u8ba1\u6781\u5ea6\u4e25\u82db\u7684\u4f20\u7edf\u533b\u7597\u5668\u68b0\u5382\u5546\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%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\uff1a<\/strong>\u4f5c\u4e3a\u56fd\u4ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\u7684\u9886\u519b\u8005\uff0cONES\u57282026\u5e74\u5df2\u6784\u5efa\u8d77\u8986\u76d6\u9879\u76ee\u96c6\u3001\u4ea7\u54c1\u3001\u6d4b\u8bd5\u4e0e\u6548\u80fd\u7684\u5168\u57df\u7ba1\u7406\u95ed\u73af\u3002\u5176\u5e95\u5c42\u67b6\u6784\u6452\u5f03\u4e86\u788e\u7247\u5316\u5de5\u5177\u7684\u62fc\u51d1\u611f\uff0c\u4ee5\u7edf\u4e00\u7684\u6570\u636e\u6a21\u578b\u8d2f\u7a7f\u4ea7\u54c1\u5168\u751f\u547d\u5468\u671f\uff0c\u4e3a\u5f3a\u5408\u89c4\u3001\u91cd\u534f\u540c\u7684\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u63d0\u4f9b\u4e86\u4e00\u7ad9\u5f0f\u3001\u53ef\u8ffd\u6eaf\u7684\u6570\u5b57\u57fa\u5ea7\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\u9700\u6c42\u5408\u89c4\u8ffd\u6eaf\uff1a<\/strong>\u652f\u6301\u4ece\u4e34\u5e8a\u9700\u6c42\u3001\u6cd5\u89c4\u6807\u51c6\u5230\u7cfb\u7edf\u6a21\u5757\u7684\u9010\u5c42\u5206\u89e3\u4e0e\u53cc\u5411\u5173\u8054\uff0c\u786e\u4fdd\u6bcf\u6761\u4ea7\u54c1\u9700\u6c42\u5747\u53ef\u5411\u4e0b\u8ffd\u6eaf\u81f3\u8bbe\u8ba1\u5b9e\u73b0\u4e0e\u6d4b\u8bd5\u9a8c\u8bc1\uff0c\u65e0\u7f1d\u5bf9\u63a5FDA 21 CFR Part 11\u7b49\u5408\u89c4\u5ba1\u8ba1\u8981\u6c42\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u4e34\u5e8a\u534f\u540c\u95ed\u73af\uff1a<\/strong>\u6253\u7834\u7814\u53d1\u3001\u6ce8\u518c\u4e0e\u4e34\u5e8a\u56e2\u961f\u7684\u4fe1\u606f\u5b64\u5c9b\uff0c\u901a\u8fc7\u9879\u76ee\u96c6\u7edf\u7b79\u591a\u4ea7\u54c1\u7ebf\u5e76\u8f68\u63a8\u8fdb\uff0c\u5b9e\u73b0\u4e34\u5e8a\u53cd\u9988\u4e0e\u4ea7\u54c1\u8fed\u4ee3\u7684\u5b9e\u65f6\u8054\u52a8\uff0c\u5927\u5e45\u7f29\u77ed\u533b\u7597\u5668\u8bc1\u7533\u62a5\u7684\u534f\u540c\u5468\u671f\u3002<\/li>\n<li><strong>\u7ed3\u6784\u5316\u8d28\u91cf\u4e0e\u98ce\u9669\u7ba1\u7406\uff1a<\/strong>\u5185\u7f6e\u53ef\u914d\u7f6e\u7684\u8bc4\u5ba1\u4e0e\u98ce\u9669\u63a7\u5236\u5de5\u4f5c\u6d41\uff0c\u5c06\u8bbe\u8ba1\u63a7\u5236\u4e0e\u98ce\u9669\u7ba1\u7406\u6d3b\u52a8\u6df1\u5ea6\u5d4c\u5165\u4ea7\u54c1\u7814\u53d1\u6d41\uff0c\u4f7f\u8d28\u91cf\u4fdd\u969c\u4ece\u88ab\u52a8\u5e94\u5bf9\u8f6c\u4e3a\u4e3b\u52a8\u9884\u9632\uff0c\u8ba9\u5408\u89c4\u6210\u4e3a\u7814\u53d1\u7684\u81ea\u7136\u4ea7\u51fa\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9ad8\u5ea6\u5951\u5408\u9700\u517c\u987e\u654f\u6377\u8fed\u4ee3\u4e0e\u5f3a\u5408\u89c4\u8ffd\u6eaf\u7684\u533b\u7597\u8f6f\u4ef6\u4e0e\u6570\u5b57\u7597\u6cd5\u4ea7\u54c1\u7ebf\uff0c\u5c24\u5176\u9002\u5408\u4e2d\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u8fdb\u884c\u591a\u6ce8\u518c\u8bc1\u4ea7\u54c1\u7684\u77e9\u9635\u5f0f\u7ba1\u7406\uff0c\u4ee5\u53ca\u8de8\u9662\u533a\u3001\u8de8\u804c\u80fd\u56e2\u961f\u7684\u590d\u6742\u4e34\u5e8a\u534f\u540c\u4ea4\u4ed8\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>ONES\u7684\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5c06\u201c\u5408\u89c4\u7ea6\u675f\u201d\u8f6c\u5316\u4e3a\u201c\u7814\u53d1\u52a8\u80fd\u201d\u3002\u9009\u578b\u4eba\u5458\u53ef\u4f18\u5148\u542f\u7528\u5176\u9884\u7f6e\u7684\u533b\u7597\u5408\u89c4\u5de5\u4f5c\u6d41\u6a21\u677f\uff0c\u5c06\u9700\u6c42\u57fa\u7ebf\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u5f3a\u7ed1\u5b9a\uff0c\u6784\u5efa\u51fa\u7b26\u5408\u5ba1\u8ba1\u6807\u51c6\u7684\u5b9e\u65f6\u8ffd\u6eaf\u77e9\u9635\u3002\u8fd9\u79cd\u5c06\u5408\u89c4\u52a8\u4f5c\u5185\u5316\u4e8e\u65e5\u5e38\u6d41\u8f6c\u7684\u5b9e\u8df5\uff0c\u65e2\u89c4\u907f\u4e86\u4e8b\u540e\u8865\u6587\u6863\u7684\u5408\u89c4\u98ce\u9669\uff0c\u53c8\u4fdd\u969c\u4e86\u533b\u7597\u4ea7\u54c1\u6301\u7eed\u4ea4\u4ed8\u7684\u6d41\u7545\u5ea6\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\u8f83\u65e9\u5165\u5c40\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u5e73\u53f0\uff0cTower\u4ee5\u654f\u6377\u9879\u76ee\u63a8\u8fdb\u4e0e\u4efb\u52a1\u53ef\u89c6\u5316\u89c1\u957f\u3002\u5b83\u901a\u8fc7\u770b\u677f\u3001\u5217\u8868\u4e0e\u7518\u7279\u56fe\u7b49\u7ecf\u5178\u89c6\u56fe\uff0c\u4e3a\u4e2d\u5c0f\u578b\u56e2\u961f\u63d0\u4f9b\u4e86\u4e00\u5957\u4e0a\u624b\u6781\u5feb\u3001\u4ea4\u4e92\u76f4\u89c2\u7684\u6807\u51c6\u5316\u7ba1\u7406\u6846\u67b6\uff0c\u964d\u4f4e\u4e86\u9879\u76ee\u843d\u5730\u7684\u6c9f\u901a\u4e0e\u5b66\u4e60\u6210\u672c\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\uff0cTower\u7684\u9002\u914d\u80fd\u529b\u4e3b\u8981\u96c6\u4e2d\u5728\u8f7b\u91cf\u7ea7\u7814\u53d1\u4e0e\u8fd0\u8425\u534f\u540c\u5c42\u9762\uff0c\u5176\u6838\u5fc3\u80fd\u529b\u4f53\u73b0\u5728\u4ee5\u4e0b\u4e24\u70b9\uff1a<\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u654f\u6377\u8fed\u4ee3\u4e0e\u8de8\u804c\u80fd\u534f\u540c\uff1a<\/strong>\u9488\u5bf9\u5065\u5eb7\u7ba1\u7406App\u6216\u8f7b\u95ee\u8bca\u5e73\u53f0\u7b49\u5feb\u8282\u594f\u4e1a\u52a1\uff0cTower\u7684\u770b\u677f\u4e0e\u4efb\u52a1\u6d41\u8f6c\u673a\u5236\u80fd\u6709\u6548\u62c9\u901a\u4ea7\u54c1\u3001\u5f00\u53d1\u4e0e\u8fd0\u8425\uff0c\u786e\u4fdd\u9700\u6c42\u5feb\u901f\u4ea4\u4ed8\uff0c\u4f46\u7f3a\u4e4f\u5bf9\u91cd\u578b\u533b\u7597\u8f6f\u4ef6\u7011\u5e03\u5f0f\u5f00\u53d1\u7684\u6df1\u5ea6\u652f\u6491\u3002<\/li>\n<li><strong>\u6807\u51c6\u5316\u4efb\u52a1\u8ffd\u8e2a\u4e0e\u57fa\u7840\u5408\u89c4\u7559\u75d5\uff1a<\/strong>\u6240\u6709\u9700\u6c42\u53d8\u66f4\u4e0e\u4efb\u52a1\u72b6\u6001\u6d41\u8f6c\u5747\u6709\u64cd\u4f5c\u65e5\u5fd7\u8bb0\u5f55\uff0c\u4e3a\u533b\u7597\u4ea7\u54c1\u7684\u57fa\u7840\u5ba1\u8ba1\u63d0\u4f9b\u4e86\u53ef\u8ffd\u6eaf\u7684\u6570\u636e\u7ebf\u7d22\uff0c\u4f46\u5728\u590d\u6742\u8ffd\u6eaf\u77e9\u9635\u4e0e\u4e25\u683c\u5408\u89c4\u7ba1\u63a7\u4e0a\u9700\u4f9d\u8d56\u4eba\u5de5\u89c4\u8303\u8865\u5145\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e2d\u7684C\u7aef\u5e94\u7528\u56e2\u961f\uff0c\u5982\u4e92\u8054\u7f51\u533b\u9662\u8fd0\u8425\u9879\u76ee\u3001\u5065\u5eb7\u6570\u636e\u8ffd\u8e2aApp\u7684\u654f\u6377\u5f00\u53d1\uff0c\u4ee5\u53ca\u533b\u7597\u5e02\u573a\u6d3b\u52a8\u7684\u8f7b\u91cf\u7ea7\u9879\u76ee\u7edf\u7b79\uff0c\u4e0d\u5efa\u8bae\u7528\u4e8e\u5f3a\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\u5d4c\u5165\u5f0f\u8f6f\u4ef6\u7814\u53d1\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5b66\u4e60\u95e8\u69db\u6781\u4f4e\uff0c\u56e2\u961f\u53ef\u5728\u4e00\u5468\u5185\u5e73\u6ed1\u8fc7\u6e21\u5e76\u8dd1\u901a\u6807\u51c6\u654f\u6377\u6d41\u7a0b\uff1b\u754c\u9762\u6e05\u723d\u514b\u5236\uff0c\u51cf\u5c11\u4e86\u5197\u4f59\u529f\u80fd\u5bf9\u6838\u5fc3\u4e1a\u52a1\u6d41\u7684\u5e72\u6270\uff1b\u8ba2\u9605\u6210\u672c\u53ef\u63a7\uff0c\u5bf9\u9884\u7b97\u6709\u9650\u7684\u521d\u521b\u578b\u533b\u7597SaaS\u56e2\u961f\u8f83\u4e3a\u53cb\u597d\u3002\u9009\u578b\u4eba\u5458\u9700\u660e\u786e\uff0c\u82e5\u4e1a\u52a1\u5f3a\u4f9d\u8d56ISO 13485\u6216IEC 62304\u7684\u6df1\u5ea6\u5408\u89c4\u95ed\u73af\uff0cTower\u9700\u914d\u5408\u4e13\u4e1aALM\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\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\u5b83\u4ee5\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684Issue\u8ffd\u8e2a\u673a\u5236\u548c\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\u8457\u79f0\uff0c\u80fd\u591f\u652f\u6491\u4ece\u9700\u6c42\u6536\u96c6\u5230\u7f3a\u9677\u8ddf\u8e2a\u7684\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u4f46\u5176\u5f00\u7bb1\u5373\u7528\u7684\u884c\u4e1a\u9002\u914d\u6027\u8f83\u5f31\uff0c\u5f80\u5f80\u9700\u8981\u6df1\u5ea6\u914d\u7f6e\u4e0e\u4e8c\u6b21\u5f00\u53d1\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>\u5f3a\u6eaf\u6e90\u4e0e\u5408\u89c4\u5ba1\u8ba1\u652f\u6491\uff1a<\/strong>\u901a\u8fc7\u63d2\u4ef6\u53ef\u5b9e\u73b0\u9700\u6c42\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5408\u89c4\u5bf9\u5168\u94fe\u8def\u5ba1\u8ba1\u8bb0\u5f55\u7684\u786c\u6027\u8981\u6c42\uff0c\u4f46\u539f\u751f\u529f\u80fd\u9700\u4f9d\u8d56\u6269\u5c55\u65b9\u80fd\u8fbe\u5230FDA\u6216NMPA\u7684\u4e25\u683c\u5ba1\u67e5\u6807\u51c6\u3002<\/li>\n<li><strong>\u9ad8\u9636\u5de5\u4f5c\u6d41\u5b9a\u5236\u5f15\u64ce\uff1a<\/strong>\u652f\u6301\u590d\u6742\u72b6\u6001\u673a\u4e0e\u6743\u9650\u6821\u9a8c\uff0c\u53ef\u9488\u5bf9\u533b\u7597\u4ea7\u54c1\u4e0d\u540c\u98ce\u9669\u7b49\u7ea7\u7684\u53d8\u66f4\uff0c\u5f3a\u5236\u5d4c\u5165\u8bc4\u5ba1\u4e0e\u7535\u5b50\u7b7e\u540d\u73af\u8282\uff0c\u786e\u4fdd\u7814\u53d1\u6d41\u7a0b\u7b26\u5408\u8d28\u91cf\u4f53\u7cfb\u89c4\u8303\u3002<\/li>\n<li><strong>\u751f\u6001\u96c6\u6210\u4e0eALM\u95ed\u73af\uff1a<\/strong>\u51ed\u501f\u6210\u719f\u7684API\u4e0e\u63d2\u4ef6\u5e02\u573a\uff0c\u53ef\u4e0e\u4ee3\u7801\u5e93\u3001\u81ea\u52a8\u5316\u6d4b\u8bd5\u5de5\u5177\u65e0\u7f1d\u5bf9\u63a5\uff0c\u6784\u5efa\u8986\u76d6\u9700\u6c42\u3001\u5f00\u53d1\u3001\u6d4b\u8bd5\u7684DevOps\u5de5\u5177\u94fe\uff0c\u652f\u6491\u533b\u7597\u8f6f\u4ef6\u7684\u6301\u7eed\u4ea4\u4ed8\u4e0e\u9a8c\u8bc1\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5177\u5907\u4e00\u5b9a\u7814\u53d1\u89c4\u6a21\u3001\u62e5\u6709\u4e13\u95e8\u914d\u7f6e\u7ba1\u7406\u56e2\u961f\uff0c\u4e14\u5bf9\u654f\u6377\u5f00\u53d1\u4e0e\u5408\u89c4\u5ba1\u8ba1\u5747\u6709\u5f3a\u8bc9\u6c42\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u3002\u82e5\u56e2\u961f\u7f3a\u4e4fJira\u6df1\u5ea6\u6cbb\u7406\u80fd\u529b\uff0c\u6781\u6613\u9677\u5165\u6d41\u7a0b\u50f5\u5316\u6216\u5408\u89c4\u65ad\u70b9\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u654f\u6377\u9879\u76ee\u7ba1\u7406\u7684\u4e8b\u5b9e\u6807\u51c6\uff0c\u751f\u6001\u6781\u5ea6\u7e41\u8363\uff1b\u5de5\u4f5c\u6d41\u5f15\u64ce\u7075\u6d3b\u5ea6\u6781\u9ad8\uff0c\u80fd\u5e94\u5bf9\u4e25\u82db\u7684\u6d41\u7a0b\u7ba1\u63a7\uff1b\u793e\u533a\u8d44\u6e90\u4e30\u5bcc\uff0c\u4eba\u624d\u50a8\u5907\u5145\u8db3\uff0c\u964d\u4f4e\u4e86\u6280\u672f\u6808\u66ff\u6362\u98ce\u9669\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\uff1a<\/strong>\u4f5c\u4e3a\u5fae\u8f6f\u65d7\u4e0b\u7684\u4f01\u4e1a\u7ea7DevOps\u5e73\u53f0\uff0cAzure DevOps\u63d0\u4f9b\u4e86\u4ece\u9700\u6c42\u89c4\u5212\u3001\u4ee3\u7801\u7ba1\u7406\u5230CI\/CD\u7684\u7aef\u5230\u7aef\u5de5\u5177\u94fe\u3002\u5176\u5e95\u5c42\u67b6\u6784\u6210\u719f\uff0c\u5c24\u5176\u5728\u4e0e\u5fae\u8f6f\u751f\u6001\u53caAzure\u4e91\u670d\u52a1\u6df1\u5ea6\u878d\u5408\u65f6\uff0c\u80fd\u4e3a\u5927\u578b\u7ec4\u7ec7\u63d0\u4f9b\u9ad8\u53ef\u7528\u7684\u534f\u4f5c\u57fa\u5ea7\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>\u9ad8\u5408\u89c4\u6027\u5de5\u4f5c\u6d41\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u652f\u6301\u7ec6\u7c92\u5ea6\u6743\u9650\u63a7\u5236\u4e0e\u5168\u94fe\u8def\u64cd\u4f5c\u65e5\u5fd7\uff0c\u6ee1\u8db3\u533b\u7597\u884c\u4e1aFDA 21 CFR Part 11\u7b49\u5408\u89c4\u5ba1\u67e5\u8981\u6c42\uff0c\u786e\u4fdd\u9700\u6c42\u4e0e\u4ee3\u7801\u53d8\u66f4\u7684\u53ef\u8ffd\u6eaf\u6027\u3002<\/li>\n<li><strong>\u7aef\u5230\u7aef\u9700\u6c42\u4e0e\u6d4b\u8bd5\u95ed\u73af\uff1a<\/strong>\u901a\u8fc7Azure Test Plans\u5b9e\u73b0\u9700\u6c42\u3001\u4ee3\u7801\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u7684\u6df1\u5ea6\u5173\u8054\uff0c\u4e3a\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7684\u9ad8\u53ef\u9760\u6027\u9a8c\u8bc1\u63d0\u4f9b\u4f53\u7cfb\u5316\u652f\u6491\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u5b89\u5168\u4e0e\u6570\u636e\u4e3b\u6743\u7ba1\u63a7\uff1a<\/strong>\u4f9d\u6258Azure\u4e91\u7684\u533a\u57df\u90e8\u7f72\u80fd\u529b\uff0c\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u6570\u636e\u672c\u5730\u5316\u5b58\u50a8\u4e0e\u9690\u79c1\u5408\u89c4\uff08\u5982HIPAA\uff09\u7684\u4e25\u82db\u7ba1\u63a7\u9700\u6c42\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5df2\u6df1\u5ea6\u7ed1\u5b9a\u5fae\u8f6f\u751f\u6001\u3001\u6709\u4e25\u683c\u5408\u89c4\u4e0e\u5ba1\u8ba1\u8bc9\u6c42\uff0c\u4e14\u7814\u53d1\u56e2\u961f\u5177\u5907\u4e00\u5b9a\u5de5\u7a0b\u5316\u57fa\u7840\u7684\u4e2d\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u7279\u522b\u662f\u6d89\u53ca\u5927\u578b\u533b\u7597\u8bbe\u5907\u8f6f\u4ef6\u6216\u6838\u5fc3\u8bca\u7597\u7cfb\u7edf\u7684\u7814\u53d1\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u96c6\u6210\u80fd\u529b\u6781\u5f3a\uff0c\u5c24\u5176\u5728Azure\u4e91\u539f\u751f\u90e8\u7f72\u4e0eActive Directory\u6743\u9650\u6253\u901a\u4e0a\u4f18\u52bf\u663e\u8457\uff1b\u5de5\u4f5c\u6d41\u5b9a\u5236\u7075\u6d3b\uff0c\u80fd\u652f\u6491\u590d\u6742\u533b\u7597\u4ea7\u54c1\u7ebf\u7684\u591a\u56e2\u961f\u534f\u540c\uff1b\u6d4b\u8bd5\u7ba1\u7406\u6a21\u5757\u4e13\u4e1a\u5ea6\u9ad8\uff0c\u6709\u6548\u964d\u4f4e\u5408\u89c4\u6027\u4ea4\u4ed8\u98ce\u9669\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\u4e13\u4e3a\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u8bbe\u8ba1\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u6df1\u8015\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u8ffd\u8e2a\u4e0e\u7f3a\u9677\u95ed\u73af\uff0c\u5176\u5e95\u5c42\u67b6\u6784\u5929\u7136\u5951\u5408\u4e25\u82db\u7684\u76d1\u7ba1\u903b\u8f91\uff0c\u662f\u533b\u7597\u5668\u68b0\u4e0e\u751f\u547d\u79d1\u5b66\u9886\u57df\u8001\u724c\u7684\u5408\u89c4\u5b88\u62a4\u8005\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\u94fe\uff1a<\/strong>\u63d0\u4f9b\u4ece\u9700\u6c42\u3001\u8bbe\u8ba1\u3001\u4ee3\u7801\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u5b9e\u65f6\u53cc\u5411\u8ffd\u6eaf\uff0c\u786e\u4fdd\u6bcf\u6761\u9700\u6c42\u5747\u53ef\u9a8c\u8bc1\uff0c\u76f4\u63a5\u6ee1\u8db3FDA 21 CFR Part 11\u4e0eIEC 62304\u7b49\u6cd5\u89c4\u5bf9\u8ffd\u6eaf\u6027\u7684\u521a\u6027\u8981\u6c42\u3002<\/li>\n<li><strong>\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u5185\u7f6e\u7b26\u5408\u89c4\u8303\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u4e0d\u53ef\u7be1\u6539\u7684\u5ba1\u8ba1\u65e5\u5fd7\uff0c\u7cfb\u7edf\u64cd\u4f5c\u8bb0\u5f55\u7cbe\u786e\u5230\u5b57\u6bb5\u7ea7\uff0c\u4e3a\u533b\u7597\u4ea7\u54c1\u4e0a\u5e02\u540e\u7684\u5ba1\u67e5\u4e0e\u5408\u89c4\u5ba1\u8ba1\u63d0\u4f9b\u94c1\u8bc1\u3002<\/li>\n<li><strong>\u98ce\u9669\u63a7\u5236\u95ed\u73af\uff1a<\/strong>\u652f\u6301\u5c06\u98ce\u9669\u5206\u6790\uff08\u5982FMEA\uff09\u4e0e\u9700\u6c42\u548c\u6d4b\u8bd5\u6df1\u5ea6\u5173\u8054\uff0c\u5b9e\u73b0\u5371\u5bb3\u8ffd\u8e2a\u4e0e\u98ce\u9669\u7f13\u89e3\u63aa\u65bd\u7684\u52a8\u6001\u95ed\u73af\u7ba1\u7406\uff0c\u800c\u975e\u5b64\u7acb\u7684\u6587\u6863\u5806\u780c\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\u8bd5\u5242\u7b49\u5f3a\u76d1\u7ba1\u4ea7\u54c1\u7684\u7814\u53d1\u7ba1\u7406\uff0c\u5c24\u5176\u9002\u5408\u5fc5\u987b\u901a\u8fc7FDA\u3001CE\u8ba4\u8bc1\u4e14\u9700\u4e25\u683c\u8bc1\u660e\u8fc7\u7a0b\u5408\u89c4\u7684\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u201c\u5408\u89c4\u5373\u4ee3\u7801\u201d\u7684\u5e95\u5c42\u903b\u8f91\uff0c\u5f00\u7bb1\u5373\u7528\u5927\u5e45\u964d\u4f4e\u9a8c\u8bc1\u6210\u672c\uff1b\u4f46\u754c\u9762\u4ea4\u4e92\u504f\u4f20\u7edf\uff0c\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\uff0c\u5bf9\u8ffd\u6c42\u654f\u6377\u8f7b\u5feb\u800c\u975e\u5f3a\u5408\u89c4\u7684\u56e2\u961f\u800c\u8a00\u7565\u663e\u7b28\u91cd\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\u3001\u6d4b\u8bd5\u4e0e\u98ce\u9669\u7ba1\u63a7\uff0c\u4e3a\u590d\u6742\u4ea7\u54c1\u7814\u53d1\u63d0\u4f9b\u7aef\u5230\u7aef\u7684\u53ef\u8ffd\u6eaf\u6027\u652f\u6301\uff0c\u662f\u4f20\u7edf\u9ad8\u5408\u89c4\u9886\u57df\u7684\u4e3b\u6d41\u9009\u62e9\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\u94fe\uff1a<\/strong>\u652f\u6301\u4ece\u7528\u6237\u9700\u6c42\u5230\u7cfb\u7edf\u8bbe\u8ba1\u3001\u4ee3\u7801\u53ca\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u4e0eIEC 62304\u7b49\u533b\u7597\u6cd5\u89c4\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u4e0e\u9632\u7be1\u6539\u7684\u4e25\u82db\u5ba1\u8ba1\u8981\u6c42\u3002<\/li>\n<li><strong>\u5185\u7f6e\u98ce\u9669\u4e0eFMEA\u7ba1\u7406\uff1a<\/strong>\u65e0\u7f1d\u96c6\u6210\u5931\u6548\u6a21\u5f0f\u4e0e\u5f71\u54cd\u5206\u6790\uff08FMEA\uff09\uff0c\u5728\u9700\u6c42\u5b9a\u4e49\u9636\u6bb5\u5373\u53ef\u540c\u6b65\u5f00\u5c55\u98ce\u9669\u8bc6\u522b\u4e0e\u63a7\u5236\uff0c\u786e\u4fdd\u533b\u7597\u4ea7\u54c1\u5b89\u5168\u8bbe\u8ba1\u524d\u7f6e\u3002<\/li>\n<li><strong>\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u95ed\u73af\uff1a<\/strong>\u6253\u901a\u9700\u6c42\u4e0e\u6d4b\u8bd5\u9a8c\u8bc1\u73af\u8282\uff0c\u81ea\u52a8\u751f\u6210\u7b26\u5408\u5ba1\u8ba1\u6807\u51c6\u7684\u8ffd\u8e2a\u77e9\u9635\uff0c\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u4ea4\u4ed8\u7684\u6587\u6863\u7f16\u5236\u6210\u672c\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u3001\u4f53\u5916\u8bca\u65ad\u8bbe\u5907\u53ca\u533b\u7597\u8f6f\u4ef6\u7b49\u53d7\u5f3a\u76d1\u7ba1\u4ea7\u54c1\u7814\u53d1\uff0c\u5c24\u5176\u9002\u5408\u9700\u9891\u7e41\u5e94\u5bf9FDA\u3001CE\u53caNMPA\u5408\u89c4\u5ba1\u8ba1\u3001\u4e14\u5bf9\u9700\u6c42\u9632\u7be1\u6539\u4e0e\u8ffd\u6eaf\u6027\u8981\u6c42\u6781\u9ad8\u7684\u4f01\u4e1a\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5c06\u5408\u89c4\u8981\u6c42\u5185\u5316\u4e3a\u7cfb\u7edf\u6d41\u7a0b\uff0c\u907f\u514d\u4eba\u5de5\u5408\u89c4\u8bc1\u636e\u62fc\u51d1\uff1b\u5f00\u7bb1\u5373\u7528\u7684\u533b\u7597\u884c\u4e1a\u6a21\u677f\u663e\u8457\u7f29\u77ed\u4f53\u7cfb\u6784\u5efa\u5468\u671f\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u4f20\u7edf\u754c\u9762\u4ea4\u4e92\u4e0e\u654f\u6377\u652f\u6301\u76f8\u5bf9\u8f83\u5f31\uff0c\u66f4\u9002\u5408\u5408\u89c4\u9a71\u52a8\u800c\u975e\u654f\u6377\u9a71\u52a8\u7684\u7814\u53d1\u56e2\u961f\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E9%80%89%E5%9E%8B%E5%86%B3%E7%AD%96%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%9C%AA%E6%9D%A5%E5%B1%95%E6%9C%9B\"><\/span>\u9009\u578b\u51b3\u7b56\u5efa\u8bae\u4e0e\u672a\u6765\u5c55\u671b<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\u6838\u5fc3\u95ee\u9898\uff0c\u7b54\u6848\u5e76\u975e\u7edd\u5bf9\uff0c\u800c\u662f\u53d6\u51b3\u4e8e\u4f01\u4e1a\u89c4\u6a21\u3001\u4ea7\u54c1\u5c5e\u6027\u4e0e\u5408\u89c4\u7b49\u7ea7\uff1a<\/p>\n<ol>\n<li><strong>\u5f3a\u5408\u89c4\u533b\u7597\u5668\u68b0\u4e0eSaMD\u7814\u53d1<\/strong>\uff1a\u9996\u9009<strong>Helix ALM<\/strong>\u6216<strong>Visure Requirements<\/strong>\uff0c\u8fd9\u4e24\u6b3e\u5de5\u5177\u5728\u9700\u6c42\u53cc\u5411\u8ffd\u6eaf\u3001\u6d4b\u8bd5\u9a8c\u8bc1\u4e0e\u884c\u4e1a\u6cd5\u89c4\u6a21\u677f\u4e0a\u5177\u5907\u539f\u751f\u4f18\u52bf\uff0c\u80fd\u6709\u6548\u964d\u4f4e\u5ba1\u8ba1\u5931\u8d25\u98ce\u9669\u3002<\/li>\n<li><strong>\u5927\u578b\u533b\u7597IT\u4e0e\u4e91\u539f\u751f\u5065\u5eb7\u5e94\u7528<\/strong>\uff1a\u63a8\u8350<strong>Azure DevOps<\/strong>\u6216<strong>ONES<\/strong>\uff0c\u524d\u8005\u5728CI\/CD\u4e0e\u4e91\u57fa\u7840\u8bbe\u65bd\u96c6\u6210\u4e0a\u65e0\u51fa\u5176\u53f3\uff0c\u540e\u8005\u5728\u6df7\u5408\u7814\u53d1\u6a21\u5f0f\u4e0e\u672c\u571f\u5316\u8de8\u90e8\u95e8\u534f\u540c\u4e0a\u66f4\u5177\u4f18\u52bf\u3002<\/li>\n<li><strong>\u654f\u6377\u9a71\u52a8\u7684\u6570\u5b57\u5065\u5eb7\u4e0e\u4e92\u8054\u7f51\u533b\u7597<\/strong>\uff1a<strong>Jira<\/strong>\u4e0e<strong>Tower<\/strong>\u662f\u63d0\u5347\u8fed\u4ee3\u6548\u7387\u7684\u4f18\u9009\uff0c\u9002\u5408\u5408\u89c4\u538b\u529b\u76f8\u5bf9\u8f83\u5c0f\u3001\u8ffd\u6c42\u5feb\u901f\u8bd5\u9519\u7684\u4e1a\u52a1\u573a\u666f\uff0c\u901a\u8fc7\u96c6\u6210\u63d2\u4ef6\u4ea6\u53ef\u8865\u9f50\u57fa\u7840\u8ffd\u6eaf\u80fd\u529b\u3002<\/li>\n<\/ol>\n<p>\u5c55\u671b\u672a\u6765\uff0c2026\u5e74\u7684\u533b\u7597\u4ea7\u54c1\u7ba1\u7406\u5c06\u66f4\u52a0\u805a\u7126\u4e8eAI\u8f85\u52a9\u7684\u5408\u89c4\u5ba1\u67e5\u4e0e\u81ea\u52a8\u5316\u8ffd\u6eaf\u751f\u6210\u3002\u9009\u62e9\u4e00\u6b3e\u5177\u5907\u5f00\u653e\u96c6\u6210\u80fd\u529b\u4e0e\u6301\u7eed\u6f14\u8fdb\u6f5c\u529b\u7684\u7cfb\u7edf\uff0c\u65b9\u80fd\u5728\u8fd9\u573a\u6570\u5b57\u5316\u4e0e\u5408\u89c4\u5316\u7684\u53cc\u91cd\u6d6a\u6f6e\u4e2d\u7acb\u4e8e\u4e0d\u8d25\u4e4b\u5730\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%E5%BF%85%E9%A1%BB%E5%85%B3%E6%B3%A8%E4%BA%A7%E5%93%81%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E7%9A%84%E5%90%88%E8%A7%84%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\u5fc5\u987b\u5173\u6ce8\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u7684\u5408\u89c4\u8ffd\u6eaf\u80fd\u529b\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\uff08\u5c24\u5176\u662f\u6d89\u53ca\u533b\u7597\u5668\u68b0\u548c\u60a3\u8005\u6570\u636e\u7684\u8f6f\u4ef6\uff09\u53d7FDA 21 CFR Part 11\u3001IEC 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class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u521d\u521b\u56e2\u961f\u901a\u5e38\u89c4\u6a21\u8f83\u5c0f\u3001\u5408\u89c4\u538b\u529b\u76f8\u5bf9\u8f83\u4f4e\u4e14\u8ffd\u6c42\u5feb\u901f\u8fed\u4ee3\uff0c\u5efa\u8bae\u9009\u62e9Tower\u6216Jira\u3002Tower\u4e0a\u624b\u6210\u672c\u6781\u4f4e\uff0c\u80fd\u5feb\u901f\u542f\u52a8\u654f\u6377\u534f\u4f5c\uff1bJira\u5219\u62e5\u6709\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u82e5\u56e2\u961f\u540e\u671f\u9700\u5f15\u5165\u57fa\u7840\u8ffd\u6eaf\uff0c\u53ef\u901a\u8fc7\u63d2\u4ef6\u8fdb\u884c\u8f7b\u91cf\u7ea7\u6269\u5c55\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E8%83%BD%E5%90%A6%E6%BB%A1%E8%B6%B3%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E7%9A%84IEC_62304%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%EF%BC%9F\"><\/span>Jira\u80fd\u5426\u6ee1\u8db3\u533b\u7597\u884c\u4e1a\u7684IEC 62304\u5408\u89c4\u8981\u6c42\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Jira\u539f\u751f\u529f\u80fd\u4e0d\u76f4\u63a5\u6ee1\u8db3IEC 62304\u7684\u6df1\u5ea6\u5408\u89c4\u8981\u6c42\uff0c\u4f46\u5176\u5f3a\u5927\u7684\u5e02\u573a\u751f\u6001\u63d0\u4f9b\u4e86\u5408\u89c4\u8ffd\u6eaf\u63d2\u4ef6\uff08\u5982Xray\u3001Zephyr Scale\u7b49\uff09\uff0c\u901a\u8fc7\u914d\u7f6e\u4e0e\u96c6\u6210\u53ef\u5b9e\u73b0\u9700\u6c42\u5230\u6d4b\u8bd5\u7684\u8ffd\u6eaf\u3002\u4e0d\u8fc7\uff0c\u5bf9\u4e8e\u6781\u9ad8\u5408\u89c4\u8981\u6c42\u7684\u4f20\u7edf\u533b\u7597\u5668\u68b0\u4f01\u4e1a\uff0c\u5176\u914d\u7f6e\u6210\u672c\u548c\u5408\u89c4\u4e25\u8c28\u5ea6\u4e0d\u5982\u4e13\u4e1a\u7684Helix ALM\u6216Visure Requirements\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"ONES%E5%9C%A8%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%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\"><\/span>ONES\u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u4e2d\u7684\u6838\u5fc3\u4f18\u52bf\u662f\u4ec0\u4e48\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>ONES\u7684\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5bf9\u4f01\u4e1a\u7ea7\u8de8\u804c\u80fd\u534f\u540c\u548c\u6df7\u5408\u7814\u53d1\u6a21\u5f0f\u7684\u652f\u6301\u3002\u533b\u7597\u4ea7\u54c1\u7814\u53d1\u5e38\u6d89\u53ca\u4e34\u5e8a\u3001\u6cd5\u89c4\u4e0e\u7814\u53d1\u591a\u90e8\u95e8\uff0cONES\u80fd\u5728\u4e00\u4e2a\u5e73\u53f0\u5185\u6253\u901a\u9700\u6c42\u3001\u9879\u76ee\u4e0e\u6d4b\u8bd5\u6d41\uff0c\u540c\u65f6\u652f\u6301\u7011\u5e03\u3001\u654f\u6377\u4e0e\u6df7\u5408\u6a21\u578b\uff0c\u975e\u5e38\u9002\u5408\u5904\u4e8e\u89c4\u6a21\u5316\u6269\u5f20\u671f\u3001\u9700\u517c\u987e\u7814\u53d1\u6548\u7387\u4e0e\u57fa\u7840\u5408\u89c4\u7ba1\u7406\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\u600e\u4e48\u9009\uff1f\u672c\u6587\u57fa\u4e8e\u7edf\u4e00\u6d4b\u8bc4\u6846\u67b6\uff0c\u5bf96\u6b3e\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\u8fdb\u884c\u80fd\u529b\u5bf9\u6bd4\uff0c\u8986\u76d6\u9002\u7528\u573a\u666f\u3001\u4f18\u52a3\u52bf\u4e0e\u843d\u5730\u5efa\u8bae\uff0c\u5e2e\u52a9\u56e2\u961f\u5feb\u901f\u5b8c\u6210\u9009\u578b\u51b3\u7b56\u3002<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_yoast_wpseo_focuskw":"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528","_yoast_wpseo_title":"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\uff1f2026\u4e3b\u6d41\u5de5\u5177\u9009\u578b\u6307\u5357","_yoast_wpseo_metadesc":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\u600e\u4e48\u9009\uff1f\u672c\u6587\u57fa\u4e8e\u7edf\u4e00\u6d4b\u8bc4\u6846\u67b6\uff0c\u5bf96\u6b3e\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4ea7\u54c1\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e2a\u597d\u7528\u8fdb\u884c\u80fd\u529b\u5bf9\u6bd4\uff0c\u8986\u76d6\u9002\u7528\u573a\u666f\u3001\u4f18\u52a3\u52bf\u4e0e\u843d\u5730\u5efa\u8bae\uff0c\u5e2e\u52a9\u56e2\u961f\u5feb\u901f\u5b8c\u6210\u9009\u578b\u51b3\u7b56\u3002","footnotes":""},"categories":[2],"tags":[],"class_list":["post-2019","post","type-post","status-publish","format-standard","hentry","category-tools"],"yoast_head":"<!-- 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