{"id":1635,"date":"2026-06-04T16:06:21","date_gmt":"2026-06-04T08:06:21","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=1635"},"modified":"2026-06-04T16:06:21","modified_gmt":"2026-06-04T08:06:21","slug":"tool-review-guide-best-128","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools\/tool-review-guide-best-128","title":{"rendered":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\uff1f\u6df1\u5ea6\u6d4b\u8bc4\u4e0e\u63a8\u8350"},"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-guide-best-128\/#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-guide-best-128\/#%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%E6%A0%B8%E5%BF%83%E9%80%89%E5%9E%8B%E7%BB%B4%E5%BA%A6\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u9009\u578b\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-guide-best-128\/#%E4%B8%BB%E6%B5%81%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%E6%A6%82%E8%A7%88\" >\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\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\/tool-review-guide-best-128\/#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-guide-best-128\/#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-guide-best-128\/#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-guide-best-128\/#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-guide-best-128\/#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-guide-best-128\/#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\/tool-review-guide-best-128\/#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-guide-best-128\/#%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%80%BB%E7%BB%93\" >\u9009\u578b\u5efa\u8bae\u4e0e\u603b\u7ed3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/wiz.cn\/blog\/tools\/tool-review-guide-best-128\/#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-guide-best-128\/#%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%E4%B8%8D%E8%83%BD%E5%8F%AA%E7%94%A8%E9%80%9A%E7%94%A8%E5%9E%8B%E9%A1%B9%E7%9B%AE%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%E5%81%9A%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u4e0d\u80fd\u53ea\u7528\u901a\u7528\u578b\u9879\u76ee\u7ba1\u7406\u5de5\u5177\u505a\u9700\u6c42\u7ba1\u7406\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-guide-best-128\/#Jira%E5%A6%82%E4%BD%95%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%E9%9C%80%E6%B1%82%EF%BC%9F\" >Jira\u5982\u4f55\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5408\u89c4\u9700\u6c42\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/wiz.cn\/blog\/tools\/tool-review-guide-best-128\/#%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%E5%93%AA%E6%AC%BE%E5%B7%A5%E5%85%B7%E6%9B%B4%E5%90%88%E9%80%82%EF%BC%9F\" >\u5bf9\u4e8e\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\uff0c\u54ea\u6b3e\u5de5\u5177\u66f4\u5408\u9002\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-guide-best-128\/#Helix_ALM%E5%92%8CVisure_Requirements%E5%9C%A8%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E7%9A%84%E6%A0%B8%E5%BF%83%E5%B7%AE%E5%BC%82%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\" >Helix ALM\u548cVisure Requirements\u5728\u533b\u7597\u884c\u4e1a\u7684\u6838\u5fc3\u5dee\u5f02\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%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\u7740\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u6570\u5b57\u5316\u8f6c\u578b\u7684\u6301\u7eed\u6df1\u5316\uff0c2026\u5e74\u7684\u884c\u4e1a\u7ade\u4e89\u5df2\u4ece\u5355\u7eaf\u7684\u529f\u80fd\u4ea4\u4ed8\u8f6c\u5411\u5408\u89c4\u6027\u3001\u5b89\u5168\u6027\u4e0e\u654f\u6377\u54cd\u5e94\u7684\u7efc\u5408\u8f83\u91cf\u3002\u533b\u7597\u5065\u5eb7\u4ea7\u54c1\u5f80\u5f80\u6d89\u53ca\u4e25\u82db\u7684\u6cd5\u89c4\u7ea6\u675f\uff08\u5982FDA\u3001CFDA\u7b49\uff09\u4e0e\u6781\u9ad8\u7684\u6570\u636e\u9690\u79c1\u8981\u6c42\uff0c\u4f20\u7edf\u7684\u901a\u7528\u578b\u9879\u76ee\u7ba1\u7406\u5de5\u5177\u5df2\u96be\u4ee5\u6ee1\u8db3\u53ef\u8ffd\u6eaf\u6027\u4e0e\u5408\u89c4\u6027\u9a8c\u8bc1\u7684\u6df1\u5ea6\u8bc9\u6c42\u3002\u9762\u5bf9\u590d\u6742\u7684\u4e1a\u52a1\u573a\u666f\uff0c<strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5<\/strong>\u6210\u4e3a\u4e86\u4f17\u591a\u7814\u53d1\u4e0e\u5408\u89c4\u56e2\u961f\u4e9f\u5f85\u89e3\u51b3\u7684\u6838\u5fc3\u95ee\u9898\u3002\u672c\u6587\u5c06\u4e3a\u60a8\u7cfb\u7edf\u68b3\u7406\u9009\u578b\u903b\u8f91\uff0c\u5e76\u5bf9\u5e02\u9762\u4e0a\u4e3b\u6d41\u7684\u5de5\u5177\u8fdb\u884c\u5256\u6790\uff0c\u52a9\u529b\u4f01\u4e1a\u7cbe\u51c6\u5339\u914d\u5951\u5408\u81ea\u8eab\u9700\u6c42\u7684\u7ba1\u7406\u5e73\u53f0\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%E6%A0%B8%E5%BF%83%E9%80%89%E5%9E%8B%E7%BB%B4%E5%BA%A6\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u7684\u6838\u5fc3\u9009\u578b\u7ef4\u5ea6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u5728\u8bc4\u4f30\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u65f6\uff0c\u4e0d\u80fd\u4ec5\u505c\u7559\u5728\u57fa\u7840\u7684\u4efb\u52a1\u534f\u540c\u5c42\u9762\uff0c\u800c\u5e94\u56f4\u7ed5\u884c\u4e1a\u7279\u6709\u7684<strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b<\/strong>\u6784\u5efa\u8bc4\u4f30\u6a21\u578b\u3002\u6211\u4eec\u5728\u9009\u578b\u4e0e\u6d4b\u8bc4\u4e2d\u4e3b\u8981\u91c7\u7528\u4ee5\u4e0b\u56db\u5927\u7ef4\u5ea6\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u8bc4\u4f30\u7ef4\u5ea6<\/th>\n<th>\u5173\u952e\u8003\u5bdf\u70b9<\/th>\n<th>\u884c\u4e1a\u91cd\u8981\u6027\u8bf4\u660e<\/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\u8db3\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u76d1\u7ba1\u53ca\u8d28\u91cf\u4f53\u7cfb\u5408\u89c4\u7684\u57fa\u7840<\/td>\n<\/tr>\n<tr>\n<td>\u6570\u636e\u5b89\u5168\u4e0e\u6743\u9650<\/td>\n<td>\u7ec6\u7c92\u5ea6\u6743\u9650\u63a7\u5236\u3001\u6570\u636e\u52a0\u5bc6\u3001\u79c1\u6709\u5316\u90e8\u7f72<\/td>\n<td>\u4fdd\u969c\u60a3\u8005\u9690\u79c1\u4e0e\u533b\u7597\u654f\u611f\u6570\u636e\u4e0d\u6cc4\u9732<\/td>\n<\/tr>\n<tr>\n<td>\u5b9a\u5236\u4e0e\u6269\u5c55\u6027<\/td>\n<td>\u5b57\u6bb5\u4e0e\u72b6\u6001\u6d41\u81ea\u5b9a\u4e49\u3001API\u5f00\u653e\u7a0b\u5ea6<\/td>\n<td>\u9002\u914d\u4e0d\u540c\u533b\u7597\u7ec6\u5206\u9886\u57df\u590d\u6742\u591a\u53d8\u7684\u4e1a\u52a1\u6d41\u7a0b<\/td>\n<\/tr>\n<tr>\n<td>\u8de8\u56e2\u961f\u534f\u4f5c\u6548\u7387<\/td>\n<td>\u654f\u6377\u652f\u6301\u3001\u6587\u6863\u534f\u540c\u3001\u591a\u9879\u76ee\u8054\u52a8<\/td>\n<td>\u6253\u901a\u4e34\u5e8a\u3001\u7814\u53d1\u4e0e\u6ce8\u518c\u56e2\u961f\u7684\u4fe1\u606f\u58c1\u5792<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E4%B8%BB%E6%B5%81%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%A6%82%E8%A7%88\"><\/span>\u4e3b\u6d41\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\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\u672c\u6b21\u5165\u9009\u76846\u6b3e\u5de5\u5177\u8fdb\u884c\u5feb\u901f\u626b\u63cf\uff0c\u4e86\u89e3\u5b83\u4eec\u57282026\u5e74\u5e02\u573a\u4e2d\u7684\u57fa\u672c\u5b9a\u4f4d\u4e0e\u6838\u5fc3\u4f18\u52bf\uff1a<\/p>\n<ul>\n<li><strong>ONES<\/strong>\uff1a\u56fd\u4ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u63d0\u4f9b\u5f3a\u5927\u7684\u9879\u76ee\u96c6\u4e0e\u9700\u6c42\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u652f\u6301\u7075\u6d3b\u914d\u7f6e\u4ee5\u9002\u5e94\u533b\u7597\u5408\u89c4\u6d41\u7a0b\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u4fa7\u91cd\u4e8e\u8f7b\u91cf\u7ea7\u534f\u540c\u4e0e\u4efb\u52a1\u63a8\u8fdb\uff0c\u9002\u5408\u533b\u7597\u521d\u521b\u56e2\u961f\u6216\u4e34\u5e8a\u534f\u8c03\u7ec4\u7ec7\u7684\u5feb\u901f\u8fed\u4ee3\u4e0e\u65e5\u5e38\u4e8b\u52a1\u8ddf\u8fdb\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u5168\u7403\u5e7f\u6cdb\u5e94\u7528\u7684\u654f\u6377\u7ba1\u7406\u5de5\u5177\uff0c\u62e5\u6709\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u53ef\u901a\u8fc7\u6269\u5c55\u5b9e\u73b0\u533b\u7597\u5408\u89c4\u8ffd\u6eaf\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u4e0b\u7684DevOps\u5229\u5668\uff0c\u63d0\u4f9b\u4f01\u4e1a\u7ea7\u5b89\u5168\u4e0e\u5408\u89c4\u5ba1\u8ba1\u80fd\u529b\uff0c\u9002\u5408\u5927\u578b\u533b\u7597IT\u57fa\u7840\u8bbe\u65bd\u56e2\u961f\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e3a\u4e25\u82db\u884c\u4e1a\u8bbe\u8ba1\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u5728\u9700\u6c42\u53ef\u8ffd\u6eaf\u6027\u4e0e\u5408\u89c4\u6d4b\u8bd5\u7ba1\u7406\u65b9\u9762\u5177\u5907\u5929\u7136\u4f18\u52bf\u3002<\/li>\n<li><strong>Visure Requirements<\/strong>\uff1a\u4e13\u4e1a\u9700\u6c42\u5de5\u7a0b\u5e73\u53f0\uff0c\u6df1\u5ea6\u652f\u6301IEC 62304\u7b49\u533b\u7597\u6807\u51c6\uff0c\u662f\u533b\u7597\u8bbe\u5907\u8f6f\u4ef6\u5408\u89c4\u7684\u5229\u5668\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>\u5de5\u5177\u6982\u51b5\uff1aONES \u4f5c\u4e3a\u56fd\u5185\u9886\u5148\u7684\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\uff0c\u57282026\u5e74\u5df2\u6784\u5efa\u51fa\u9ad8\u5ea6\u6210\u719f\u7684\u4f01\u4e1a\u7ea7\u6548\u80fd\u77e9\u9635\u3002\u5b83\u5e76\u975e\u5355\u7eaf\u7684\u5de5\u5355\u6d41\u8f6c\u5de5\u5177\uff0c\u800c\u662f\u4ee5\u5168\u5c40\u89c6\u89d2\u6253\u901a\u9879\u76ee\u3001\u9700\u6c42\u4e0e\u8d28\u91cf\u6d41\u7684\u67a2\u7ebd\u3002\u5bf9\u4e8e\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u800c\u8a00\uff0cONES \u7684\u6838\u5fc3\u4ef7\u503c\u5728\u4e8e\u5c06\u5408\u89c4\u6027\u8981\u6c42\u5185\u5316\u4e3a\u7814\u53d1\u6d41\u6c34\u7ebf\u7684\u9ed8\u8ba4\u89c4\u5219\uff0c\u8ba9\u4e25\u8c28\u7684\u6d41\u7a0b\u6210\u4e3a\u5e95\u5ea7\u800c\u975e\u963b\u529b\uff0c\u4e3a\u6570\u5b57\u5316\u8f6c\u578b\u63d0\u4f9b\u7a33\u5065\u652f\u6491\u3002<\/p>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1aONES \u5728\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u9002\u914d\u6027\uff0c\u96c6\u4e2d\u4f53\u73b0\u5728\u5bf9\u5f3a\u5408\u89c4\u4e0e\u9ad8\u534f\u540c\u573a\u666f\u7684\u6df1\u5ea6\u89e3\u6784\u4e0e\u8d4b\u80fd\uff1a<\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u9700\u6c42\u53cc\u5411\u8ffd\u6eaf\uff1a<\/strong>\u63d0\u4f9b\u4ece\u7528\u6237\u6545\u4e8b\u5230\u4ee3\u7801\u63d0\u4ea4\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u5168\u5c40\u5173\u8054\u3002\u5728\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\uff08SaMD\uff09\u5ba1\u8ba1\u4e2d\uff0c\u53ef\u4e00\u952e\u751f\u6210\u7b26\u5408FDA 21 CFR Part 11\u4e0eIEC 62304\u6807\u51c6\u7684\u8ffd\u6eaf\u77e9\u9635\uff0c\u5f7b\u5e95\u544a\u522b\u624b\u52a8\u62fc\u51d1\u6587\u6863\u7684\u5408\u89c4\u9635\u75db\u3002<\/li>\n<li><strong>\u7ed3\u6784\u5316\u5408\u89c4\u57fa\u7ebf\u7ba1\u63a7\uff1a<\/strong>\u9488\u5bf9\u533b\u7597\u9700\u6c42\u9ad8\u9891\u53d8\u66f4\uff0cONES \u652f\u6301\u9700\u6c42\u8bc4\u5ba1\u9501\u5b9a\u4e0e\u57fa\u7ebf\u5316\u5feb\u7167\u3002\u4efb\u4f55\u53d8\u66f4\u5747\u89e6\u53d1\u5f71\u54cd\u57df\u5206\u6790\uff0c\u786e\u4fdd\u9700\u6c42\u6f14\u8fdb\u59cb\u7ec8\u5904\u4e8e\u53d7\u63a7\u72b6\u6001\uff0c\u6ee1\u8db3\u836f\u76d1\u5c40\u98de\u68c0\u65f6\u7684\u6570\u636e\u4e0d\u53ef\u7be1\u6539\u4e0e\u8fc7\u7a0b\u56de\u6eaf\u8981\u6c42\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u89d2\u8272\u65e0\u7f1d\u534f\u540c\uff1a<\/strong>\u533b\u7597\u4ea7\u54c1\u9700\u4e34\u5e8a\u3001\u6cd5\u89c4\u4e0e\u7814\u53d1\u6df1\u5ea6\u5171\u521b\u3002ONES \u63d0\u4f9b\u591a\u89d2\u8272\u89c6\u56fe\u4e0e\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\uff0c\u8ba9\u4e34\u5e8a\u4e13\u5bb6\u3001\u5408\u89c4\u5b98\u4e0e\u5de5\u7a0b\u5e08\u5728\u540c\u4e00\u4e0a\u4e0b\u6587\u5bf9\u8bdd\uff0c\u6d88\u9664\u4e1a\u52a1\u4e0e\u7814\u53d1\u95f4\u7684\u4fe1\u606f\u5b64\u5c9b\u3002<\/li>\n<\/ul>\n<p>\u9002\u7528\u573a\u666f\uff1a\u7279\u522b\u9002\u5408\u4e2d\u5927\u578b\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u3001\u521b\u65b0\u836f\u4f01\u6570\u5b57\u5316\u56e2\u961f\u53ca\u5668\u68b0\u8f6f\u4ef6\u5f00\u53d1\u5546\uff0c\u5728\u63a8\u8fdb\u6838\u5fc3\u4e1a\u52a1\u7cfb\u7edf\u3001\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u7cfb\u7edf\uff08EDC\uff09\u6216\u4e09\u7c7b\u5668\u68b0\u8f6f\u4ef6\u8fed\u4ee3\u65f6\uff0c\u9700\u517c\u987e\u654f\u6377\u4ea4\u4ed8\u4e0e\u4e25\u82db\u5408\u89c4\u5ba1\u67e5\u7684\u590d\u6742\u9879\u76ee\u7fa4\u3002<\/p>\n<p>\u4f18\u52bf\u4eae\u70b9\uff1aONES \u7684\u7a81\u51fa\u4eae\u70b9\u5728\u4e8e\u5c06\u201c\u5408\u89c4\u5373\u4ee3\u7801\u201d\u7406\u5ff5\u6df1\u5ea6\u878d\u5165\u7814\u53d1\u94fe\u8def\u3002\u9009\u578b\u56e2\u961f\u53ef\u76f4\u63a5\u590d\u7528\u5176\u5185\u7f6e\u7684\u533b\u7597\u884c\u4e1a\u9879\u76ee\u6a21\u677f\u4e0e\u5ba1\u6279\u6d41\uff0c\u5c06\u539f\u672c\u6ede\u540e\u7684\u5408\u89c4\u68c0\u67e5\u70b9\u5de6\u79fb\u81f3\u9700\u6c42\u5b9a\u4e49\u9636\u6bb5\u3002\u5b9e\u8df5\u5efa\u8bae\uff1a\u5b9e\u65bd\u65f6\u4f18\u5148\u914d\u7f6e\u9700\u6c42\u5c5e\u6027\u6a21\u677f\u4e0e\u8ffd\u6eaf\u62a5\u544a\uff0c\u5373\u53ef\u5728\u9996\u4e2a\u8fed\u4ee3\u5185\u5b9e\u73b0\u5408\u89c4\u8d44\u4ea7\u81ea\u52a8\u6c89\u6dc0\uff0c\u8ba9\u8d28\u91cf\u4fdd\u969c\u4e0e\u7814\u53d1\u6548\u80fd\u540c\u9891\u5171\u632f\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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5+ONES \u4ea7\u54c1\u5168\u666f\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Tower\"><\/span>Tower<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong> Tower\u662f\u56fd\u5185\u8001\u724c\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u4e0e\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0c\u4ee5\u201c\u6613\u7528\u3001\u8f7b\u91cf\u3001\u654f\u6377\u201d\u4e3a\u6838\u5fc3\u8bbe\u8ba1\u7406\u5ff5\uff0c\u4e3b\u6253\u770b\u677f\u4e0e\u4efb\u52a1\u6d41\u8f6c\u3002\u5b83\u5e76\u975e\u4e3a\u5f3a\u5408\u89c4\u884c\u4e1a\u539f\u751f\u6784\u5efa\uff0c\u800c\u662f\u901a\u8fc7\u7075\u6d3b\u7684\u4efb\u52a1\u5c5e\u6027\u4e0e\u9879\u76ee\u6a21\u677f\uff0c\u4e3a\u4e2d\u5c0f\u578b\u56e2\u961f\u63d0\u4f9b\u6807\u51c6\u5316\u7684\u534f\u540c\u5de5\u4f5c\u53f0\u3002\u57282026\u5e74\u7684\u534f\u540c\u751f\u6001\u4e2d\uff0cTower\u4f9d\u7136\u4fdd\u6301\u7740\u4f4e\u95e8\u69db\u4e0e\u5feb\u901f\u90e8\u7f72\u7684\u4f18\u52bf\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong>\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\uff0cTower\u7684\u9002\u914d\u6027\u504f\u5411\u4e8e\u8f7b\u91cf\u7ea7\u9700\u6c42\u6c60\u7ba1\u7406\u4e0e\u8de8\u804c\u80fd\u65e5\u5e38\u534f\u540c\uff0c\u5176\u6838\u5fc3\u80fd\u529b\u4f53\u73b0\u5728\uff1a<\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u9700\u6c42\u6c60\u4e0e\u770b\u677f\u6d41\u8f6c\uff1a<\/strong>\u652f\u6301\u4ee5\u770b\u677f\u5f62\u5f0f\u5feb\u901f\u5efa\u7acb\u9700\u6c42\u6536\u96c6\u6c60\uff0c\u901a\u8fc7\u81ea\u5b9a\u4e49\u6807\u7b7e\uff08\u5982\u201c\u5408\u89c4\u5f85\u5ba1\u201d\u3001\u201c\u6570\u636e\u5b89\u5168\u8bc4\u4f30\u201d\uff09\u5b9e\u73b0\u7b80\u6613\u7684\u9700\u6c42\u5206\u7c7b\u4e0e\u72b6\u6001\u6d41\u8f6c\uff0c\u9002\u5408\u975e\u91cd\u5ea6\u5408\u89c4\u7ba1\u63a7\u7684\u65e5\u5e38\u9700\u6c42\u8ddf\u8fdb\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u56e2\u961f\u534f\u540c\u95ed\u73af\uff1a<\/strong>\u5185\u7f6e\u6587\u6863\u534f\u540c\u4e0e\u4efb\u52a1\u8bc4\u8bba\u673a\u5236\uff0c\u4e34\u5e8a\u8fd0\u8425\u3001\u5e02\u573a\u4e0e\u7814\u53d1\u7b49\u4e1a\u52a1\u4fa7\u80fd\u5728\u4e00\u4e2a\u4efb\u52a1\u5361\u7247\u4e0b\u5b8c\u6210\u9700\u6c42\u786e\u8ba4\u4e0e\u53cd\u9988\uff0c\u964d\u4f4e\u8de8\u90e8\u95e8\u6c9f\u901a\u635f\u8017\u3002<\/li>\n<li><strong>\u57fa\u7840\u53ef\u8ffd\u6eaf\u6027\u652f\u6301\uff1a<\/strong>\u901a\u8fc7\u4efb\u52a1\u5173\u8054\u4e0e\u6d3b\u52a8\u65e5\u5fd7\uff0c\u63d0\u4f9b\u9700\u6c42\u4ece\u63d0\u51fa\u5230\u4ea4\u4ed8\u7684\u57fa\u7840\u8ffd\u8e2a\u94fe\u8def\uff0c\u4f46\u7f3a\u4e4f\u539f\u751f\u7684\u7aef\u5230\u7aef\u5408\u89c4\u77e9\u9635\u4e0e\u9a8c\u8bc1\u8ffd\u8e2a\u80fd\u529b\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5065\u5eb7\u4f01\u4e1a\u5185\u90e8\u975e\u6838\u5fc3\u4e1a\u52a1\u7cfb\u7edf\uff08\u5982\u5185\u90e8OA\u3001\u8425\u9500\u6d3b\u52a8\u7ba1\u7406\u3001\u8f7b\u91cf\u7ea7\u60a3\u8005\u793e\u533a\u8fd0\u8425\uff09\u7684\u9700\u6c42\u7ba1\u7406\uff0c\u4ee5\u53ca\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\u5728\u65e9\u671fMVP\u9636\u6bb5\u7684\u654f\u6377\u8fed\u4ee3\u3002\u5bf9\u4e8e\u5f3a\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u6216\u6838\u5fc3HIS\u7cfb\u7edf\u7814\u53d1\uff0cTower\u5728\u5408\u89c4\u4e0e\u8ffd\u6eaf\u6df1\u5ea6\u4e0a\u5b58\u5728\u660e\u663e\u77ed\u677f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>Tower\u7684\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u6781\u4f4e\u7684\u5b66\u4e60\u6210\u672c\u4e0e\u6781\u5feb\u7684\u843d\u5730\u901f\u5ea6\u3002\u4e1a\u52a1\u4eba\u5458\u65e0\u9700\u57f9\u8bad\u5373\u53ef\u4e0a\u624b\u64cd\u4f5c\uff0c\u6709\u6548\u89e3\u51b3\u4e86\u533b\u7597\u4f01\u4e1a\u4e2d\u975e\u6280\u672f\u56e2\u961f\u53c2\u4e0e\u9700\u6c42\u534f\u540c\u7684\u95e8\u69db\u95ee\u9898\u3002\u5176\u8f7b\u91cf\u5316\u67b6\u6784\u8ba9\u56e2\u961f\u65e0\u9700\u80cc\u8d1f\u91cd\u578b\u5de5\u5177\u7684\u8fd0\u7ef4\u8d1f\u62c5\uff0c\u5373\u53ef\u5b9e\u73b0\u9700\u6c42\u4ece\u63d0\u51fa\u5230\u5f00\u53d1\u8ddf\u8fdb\u7684\u900f\u660e\u5316\uff0c\u662f\u8f7b\u91cf\u7ea7\u4e1a\u52a1\u573a\u666f\u4e0b\u6027\u4ef7\u6bd4\u6781\u9ad8\u7684\u654f\u6377\u534f\u540c\u9009\u62e9\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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5+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\u7814\u53d1\u8ffd\u8e2a\u9886\u57df\u7684\u57fa\u77f3\u3002\u5176\u5e95\u5c42\u903b\u8f91\u57fa\u4e8eIssue\u8ffd\u8e2a\uff0c\u901a\u8fc7\u9ad8\u5ea6\u81ea\u5b9a\u4e49\u7684\u5de5\u4f5c\u6d41\u4e0e\u5b57\u6bb5\u914d\u7f6e\uff0c\u652f\u6491\u4ece\u53f2\u8bd7\u7ea7\u9700\u6c42\u5230\u5b50\u4efb\u52a1\u7684\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u5177\u5907\u6781\u5f3a\u7684\u5e95\u5c42\u6269\u5c55\u6027\u4e0e\u751f\u6001\u6574\u5408\u80fd\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>\u53ef\u8ffd\u6eaf\u6027\u77e9\u9635\u6784\u5efa\uff1a<\/strong>\u501f\u52a9\u9ad8\u7ea7\u8def\u7ebf\u56fe\u4e0eIssue Link\u529f\u80fd\uff0c\u53ef\u5b9e\u73b0\u4ece\u4e34\u5e8a\u8bc9\u6c42\u3001\u5408\u89c4\u57fa\u7ebf\u5230\u4ee3\u7801\u63d0\u4ea4\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u5ba1\u8ba1\u7ebf\u7d22\u8981\u6c42\u3002<\/li>\n<li><strong>\u5408\u89c4\u5de5\u4f5c\u6d41\u5f3a\u5236\u7ba1\u63a7\uff1a<\/strong>\u901a\u8fc7\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\u4e0e\u6743\u9650\u62e6\u622a\uff0c\u5f3a\u5236\u843d\u5b9e\u533b\u7597\u8f6f\u4ef6\u9700\u6c42\u8bc4\u5ba1\u4e0e\u53d8\u66f4\u5ba1\u6279\u8282\u70b9\uff0c\u786e\u4fdd\u9700\u6c42\u53d8\u66f4\u5fc5\u987b\u7ecf\u8fc7\u5408\u89c4\u4eba\u5458\u7b7e\u6838\u3002<\/li>\n<li><strong>\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u95ed\u73af\uff1a<\/strong>\u7ed3\u5408Zephyr\u7b49\u6d4b\u8bd5\u751f\u6001\u63d2\u4ef6\uff0c\u5c06\u9700\u6c42\u4e0e\u6d4b\u8bd5\u7528\u4f8b\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u652f\u6491\u533b\u7597\u884c\u4e1a\u4e25\u683c\u7684IQ\/OQ\/PQ\u9a8c\u8bc1\u95ed\u73af\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5177\u5907\u4e00\u5b9a\u7814\u53d1\u6548\u80fd\u57fa\u7840\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\u4e0eCRO\u673a\u6784\uff0c\u5c24\u5176\u662f\u7814\u53d1\u56e2\u961f\u89c4\u6a21\u8f83\u5927\u3001\u91c7\u7528\u654f\u6377\u8fed\u4ee3\u4f46\u9700\u517c\u987e\u5f3a\u5408\u89c4\u5ba1\u8ba1\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u6216\u6570\u5b57\u7597\u6cd5\u9879\u76ee\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u654f\u6377\u7ba1\u7406\u6807\u6746\uff0c\u5de5\u4f5c\u6d41\u81ea\u5b9a\u4e49\u80fd\u529b\u6781\u5f3a\uff1b\u63d2\u4ef6\u751f\u6001\u6781\u5176\u4e30\u5bcc\uff0c\u80fd\u901a\u8fc7\u6269\u5c55\u8865\u8db3\u533b\u7597\u884c\u4e1a\u6df1\u5ea6\u5408\u89c4\u9700\u6c42\uff1b\u4e0eConfluence\u8054\u52a8\u53ef\u6784\u5efa\u5b8c\u5584\u7684\u9700\u6c42\u6587\u6863\u4e0e\u5408\u89c4\u77e5\u8bc6\u5e93\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u5408\u89c4\u8ffd\u6eaf\u9ad8\u5ea6\u4f9d\u8d56\u63d2\u4ef6\u4e0e\u914d\u7f6e\uff0c\u521d\u59cb\u642d\u5efa\u6210\u672c\u8f83\u9ad8\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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5+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\u4ece\u9700\u6c42\u89c4\u5212\u3001\u4ee3\u7801\u7ba1\u7406\u5230CI\/CD\u7684\u5168\u94fe\u8def\u80fd\u529b\u3002\u5176\u5e95\u5c42\u67b6\u6784\u6210\u719f\uff0c\u751f\u6001\u6269\u5c55\u6027\u5f3a\uff0c\u662f\u5927\u578b\u7ec4\u7ec7\u6784\u5efa\u7814\u53d1\u8fd0\u8425\u4f53\u7cfb\u7684\u57fa\u7840\u8bbe\u65bd\u7ea7\u9009\u62e9\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\uff1a<\/strong>\u901a\u8fc7Work Item\u94fe\u63a5\u673a\u5236\uff0c\u53ef\u5efa\u7acb\u9700\u6c42\u3001\u4ee3\u7801\u3001\u6d4b\u8bd5\u7528\u4f8b\u4e0e\u53d1\u5e03\u7684\u5168\u94fe\u8def\u8ffd\u6eaf\uff0c\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u5bf9\u6570\u636e\u5b8c\u6574\u6027\u4e0e\u53d8\u66f4\u5ba1\u8ba1\u7684\u4e25\u82db\u8981\u6c42\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u6743\u9650\u4e0e\u6570\u636e\u9694\u79bb\uff1a<\/strong>\u4f9d\u6258Azure AD\u5b9e\u73b0\u7ec6\u7c92\u5ea6RBAC\u6743\u9650\u7ba1\u63a7\uff0c\u652f\u6301\u8de8\u79d1\u5ba4\u9879\u76ee\u7684\u6570\u636e\u9694\u79bb\uff0c\u786e\u4fdd\u60a3\u8005\u9690\u79c1\u6570\u636e\u4e0e\u6838\u5fc3\u7814\u53d1\u8d44\u4ea7\u7684\u5b89\u5168\u8fb9\u754c\u3002<\/li>\n<li><strong>\u5408\u89c4\u6d41\u7a0b\u81ea\u52a8\u5316\uff1a<\/strong>\u501f\u52a9\u5185\u7f6e\u5ba1\u6279\u95e8\u7981\u4e0e\u5b9a\u5236\u5316\u72b6\u6001\u673a\uff0c\u53ef\u5f3a\u5236\u843d\u5730\u533b\u7597\u8f6f\u4ef6\u7684\u53d8\u66f4\u63a7\u5236\u6d41\u7a0b\uff0c\u9632\u6b62\u672a\u7ecf\u8bc4\u5ba1\u7684\u9700\u6c42\u53d8\u66f4\u6d41\u5165\u5f00\u53d1\u73af\u8282\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\u9700\u6ee1\u8db3\u4e25\u683c\u5408\u89c4\u5ba1\u8ba1\u8981\u6c42\u7684\u5927\u578b\u533b\u7597\u5668\u68b0\u7814\u53d1\u4f01\u4e1a\u6216\u8de8\u56fd\u836f\u4f01\uff0c\u5c24\u5176\u9002\u7528\u4e8e\u7814\u53d1\u4e0eIT\u8fd0\u7ef4\u4e00\u4f53\u5316\u7ba1\u7406\u7684\u590d\u6742\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u4e0eGitHub\u53caAzure\u4e91\u65e0\u7f1d\u96c6\u6210\uff0c\u63d0\u4f9b\u4f01\u4e1a\u7ea7\u5b89\u5168\u4e0e\u9ad8\u53ef\u7528\u6027\uff1b\u6d4b\u8bd5\u8ba1\u5212\u6a21\u5757\u4e13\u4e1a\uff0c\u80fd\u6709\u6548\u652f\u6491\u533b\u7597\u8f6f\u4ef6\u7684\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff1b\u4f46\u914d\u7f6e\u5b66\u4e60\u66f2\u7ebf\u9661\u5ced\uff0c\u5bf9\u4e2d\u5c0f\u578b\u533b\u7597\u56e2\u961f\u800c\u8a00\u8fd0\u7ef4\u6210\u672c\u504f\u9ad8\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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5+Azure DevOps \u4ea7\u54c1\u56fe\" \/><\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_ALM\"><\/span>Helix ALM<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Helix ALM \u662f\u4e00\u6b3e\u4e13\u4e3a\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u6253\u9020\u7684\u5e94\u7528\u751f\u547d\u5468\u671f\u7ba1\u7406\u5e73\u53f0\uff0c\u5176\u5728\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u8ffd\u8e2a\u4e0e\u7f3a\u9677\u5173\u8054\u4e0a\u5177\u5907\u6781\u5f3a\u7684\u7aef\u5230\u7aef\u95ed\u73af\u80fd\u529b\u3002\u5bf9\u4e8e\u533b\u7597\u5065\u5eb7\u8fd9\u7c7b\u5bf9\u5408\u89c4\u4e0e\u8ffd\u6eaf\u6709\u4e25\u82db\u8981\u6c42\u7684\u9886\u57df\uff0cHelix ALM \u63d0\u4f9b\u4e86\u4ece\u9700\u6c42\u57fa\u7ebf\u5230\u4ee3\u7801\u53d8\u66f4\u7684\u5168\u94fe\u8def\u900f\u660e\u5ea6\uff0c\u662f\u4f20\u7edf\u91cd\u578b\u5408\u89c4\u9879\u76ee\u7684\u5b88\u95e8\u4eba\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\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\u4e1a\u52a1\u9700\u6c42\u3001\u8f6f\u4ef6\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u4e0e\u7f3a\u9677\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u786e\u4fdd\u6ee1\u8db3FDA 21 CFR Part 11\u7b49\u6cd5\u89c4\u5ba1\u8ba1\u8981\u6c42\uff0c\u968f\u65f6\u53ef\u8f93\u51fa\u5408\u89c4\u8bc1\u636e\u3002<\/li>\n<li><strong>\u57fa\u7ebf\u4e0e\u53d8\u66f4\u5f3a\u7ba1\u63a7\uff1a<\/strong>\u652f\u6301\u4e25\u5bc6\u7684\u57fa\u7ebf\u9501\u5b9a\u4e0e\u53d8\u66f4\u5f71\u54cd\u5206\u6790\uff0c\u4efb\u4f55\u9700\u6c42\u53d8\u66f4\u5747\u9700\u7ecf\u8fc7\u5ba1\u6279\u6d41\uff0c\u9632\u6b62\u533b\u7597\u4ea7\u54c1\u8fed\u4ee3\u4e2d\u56e0\u968f\u610f\u53d8\u66f4\u5f15\u5165\u81f4\u547d\u98ce\u9669\u3002<\/li>\n<li><strong>\u5185\u7f6e\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a\uff1a<\/strong>\u7cfb\u7edf\u539f\u751f\u652f\u6301\u7b26\u5408\u89c4\u8303\u7684\u7535\u5b50\u7b7e\u540d\u4e0e\u4e0d\u53ef\u7be1\u6539\u7684\u64cd\u4f5c\u65e5\u5fd7\uff0c\u514d\u53bb\u4e8c\u6b21\u5f00\u53d1\u5373\u53ef\u843d\u5730\u533b\u7597\u884c\u4e1a\u7684\u6570\u636e\u5b8c\u6574\u6027\u8981\u6c42\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u5bf9\u5408\u89c4\u6027\u8981\u6c42\u6781\u9ad8\u7684\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u7814\u53d1\u3001\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7ba1\u7406\u7cfb\u7edf\u5f00\u53d1\uff0c\u4ee5\u53ca\u9700\u8981\u5e94\u5bf9FDA\u3001CE\u7b49\u4e25\u683c\u76d1\u7ba1\u5ba1\u8ba1\u7684\u751f\u547d\u79d1\u5b66\u4f01\u4e1a\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u7684\u62a4\u57ce\u6cb3\u5728\u4e8e\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6846\u67b6\u4e0e\u65e0\u61c8\u53ef\u51fb\u7684\u8ffd\u6eaf\u77e9\u9635\u3002\u5bf9\u4e8e\u9009\u578b\u4eba\u5458\u800c\u8a00\uff0c\u82e5\u60a8\u7684\u7ec4\u7ec7\u6b63\u4e3a\u5982\u4f55\u4f4e\u6210\u672c\u901a\u8fc7\u4e25\u82db\u7684\u533b\u7597\u5408\u89c4\u5ba1\u8ba1\u800c\u82e6\u607c\uff0cHelix ALM \u662f\u964d\u4f4e\u5408\u89c4\u98ce\u9669\u7684\u6700\u4f18\u89e3\uff1b\u4f46\u9700\u6ce8\u610f\u5176\u90e8\u7f72\u4e0e\u5b66\u4e60\u6210\u672c\u8f83\u9ad8\uff0c\u4e0d\u9002\u5408\u8f7b\u91cf\u7ea7\u6216\u654f\u6377\u63a2\u7d22\u578b\u56e2\u961f\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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5+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\u9ad8\u5408\u89c4\u6027\u884c\u4e1a\u7684\u7aef\u5230\u7aef\u9700\u6c42\u4e0eALM\u7ba1\u7406\u5e73\u53f0\u3002\u5386\u7ecf\u591a\u5e74\u6df1\u8015\uff0c\u5176\u5728\u822a\u7a7a\u3001\u6c7d\u8f66\u4e0e\u533b\u7597\u8bbe\u5907\u7b49\u5f3a\u76d1\u7ba1\u9886\u57df\u79ef\u7d2f\u4e86\u6df1\u539a\u7684\u884c\u4e1aKnow-how\uff0c\u5c24\u5176\u64c5\u957f\u5904\u7406\u590d\u6742\u7cfb\u7edf\u5de5\u7a0b\u7684\u8ffd\u6eaf\u4e0e\u5408\u89c4\u6311\u6218\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u53cc\u5411\u53ef\u8ffd\u6eaf\u6027\uff1a<\/strong>\u652f\u6301\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u9700\u6c42\u5230\u6d4b\u8bd5\u7528\u4f8b\u7684\u5168\u94fe\u8def\u95ed\u73af\u8ffd\u8e2a\uff0c\u65e0\u7f1d\u5bf9\u63a5IEC 62304\u7b49\u533b\u7597\u8f6f\u4ef6\u751f\u547d\u5468\u671f\u6807\u51c6\uff0c\u786e\u4fdd\u5ba1\u8ba1\u65e0\u6b7b\u89d2\u3002<\/li>\n<li><strong>\u5185\u7f6e\u5408\u89c4\u6a21\u677f\u4e0e\u9a8c\u8bc1\u7ba1\u7406\uff1a<\/strong>\u5f00\u7bb1\u5373\u7528FDA\u3001ISO 13485\u7b49\u6cd5\u89c4\u6846\u67b6\u6a21\u677f\uff0c\u5c06\u5408\u89c4\u9a8c\u8bc1\u76f4\u63a5\u5d4c\u5165\u9700\u6c42\u5b9a\u4e49\u6d41\u7a0b\uff0c\u964d\u4f4e\u4eba\u4e3a\u9057\u6f0f\u98ce\u9669\u3002<\/li>\n<li><strong>\u98ce\u9669\u4e0eFMEA\u8054\u52a8\uff1a<\/strong>\u9700\u6c42\u4e0e\u98ce\u9669\u7ba1\u7406\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u652f\u6301\u5728\u9700\u6c42\u9636\u6bb5\u76f4\u63a5\u53d1\u8d77DFMEA\/PFMEA\u5206\u6790\uff0c\u5b9e\u73b0\u98ce\u9669\u63a7\u5236\u7684\u524d\u7f6e\u5316\u4e0e\u6570\u636e\u8054\u52a8\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u7814\u53d1\u3001\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u8bbe\u5907\u5f00\u53d1\u53ca\u53d7FDA\/CE\u5f3a\u76d1\u7ba1\u7684\u751f\u547d\u79d1\u5b66\u9879\u76ee\u3002\u5bf9\u4e8e\u9700\u5e94\u5bf9\u4e25\u683c\u5ba1\u8ba1\u3001\u4e14\u56e2\u961f\u5177\u5907\u4e00\u5b9a\u7cfb\u7edf\u5de5\u7a0b\u57fa\u7840\u7684\u5408\u89c4\u9a71\u52a8\u578b\u7ec4\u7ec7\u5c24\u4e3a\u5951\u5408\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6700\u5927\u4f18\u52bf\u5728\u4e8e\u5c06\u201c\u5408\u89c4\u201d\u4ece\u5916\u90e8\u5ba1\u67e5\u8f6c\u5316\u4e3a\u5185\u751f\u7684\u7cfb\u7edf\u80fd\u529b\uff0c\u5927\u5e45\u7f29\u77ed\u5ba1\u8ba1\u51c6\u5907\u5468\u671f\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u754c\u9762\u4ea4\u4e92\u4e0e\u914d\u7f6e\u903b\u8f91\u504f\u5411\u4f20\u7edf\u5de5\u7a0b\u601d\u7ef4\uff0c\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\uff0c\u5efa\u8bae\u7ec4\u7ec7\u5728\u5f15\u5165\u65f6\u914d\u5957\u4e13\u9879\u57f9\u8bad\u4e0e\u6d41\u7a0b\u91cd\u5851\uff0c\u4ee5\u907f\u514d\u56e0\u914d\u7f6e\u4e0d\u5f53\u5bfc\u81f4\u7684\u5de5\u5177\u50f5\u5316\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%80%BB%E7%BB%93\"><\/span>\u9009\u578b\u5efa\u8bae\u4e0e\u603b\u7ed3<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7efc\u5408\u6765\u770b\uff0c\u4e0d\u540c\u89c4\u6a21\u7684\u533b\u7597\u5065\u5eb7\u56e2\u961f\u5e94\u57fa\u4e8e\u81ea\u8eab\u5408\u89c4\u538b\u529b\u4e0e\u7814\u53d1\u6a21\u5f0f\u8fdb\u884c\u9009\u62e9\u3002\u5bf9\u4e8e\u5fc5\u987b\u6ee1\u8db3IEC 62304\u7b49\u4e25\u683c\u6cd5\u89c4\u4e14\u9884\u7b97\u5145\u8db3\u7684\u533b\u7597\u5668\u68b0\u4f01\u4e1a\uff0c<strong>Helix ALM<\/strong>\u4e0e<strong>Visure Requirements<\/strong>\u662f\u89c4\u907f\u5408\u89c4\u98ce\u9669\u7684\u9996\u9009\uff1b\u5bf9\u4e8e\u6ce8\u91cdDevOps\u4e00\u4f53\u5316\u4e14\u5f3a\u8c03\u6570\u636e\u4e3b\u6743\u7684\u5927\u578b\u533b\u7597\u4fe1\u606f\u5316\u56e2\u961f\uff0c<strong>Azure DevOps<\/strong>\u66f4\u4e3a\u5951\u5408\uff1b\u800c\u5bf9\u4e8e\u5bfb\u6c42\u6027\u4ef7\u6bd4\u4e0e\u654f\u6377\u8fed\u4ee3\u3001\u540c\u65f6\u9700\u8981\u4e00\u5b9a\u5b9a\u5236\u7a7a\u95f4\u6765\u6ee1\u8db3\u57fa\u7840\u5408\u89c4\u7684\u672c\u571f\u4f01\u4e1a\uff0c<strong>ONES<\/strong>\u4e0e<strong>Jira<\/strong>\u80fd\u591f\u63d0\u4f9b\u5e73\u8861\u7684\u89e3\u51b3\u65b9\u6848\uff1b<strong>Tower<\/strong>\u5219\u66f4\u9002\u5408\u5408\u89c4\u8d1f\u62c5\u8f83\u8f7b\u3001\u8ffd\u6c42\u6781\u81f4\u534f\u540c\u6548\u7387\u7684\u8f7b\u91cf\u7ea7\u56e2\u961f\u30022026\u5e74\uff0c\u660e\u786e\u81ea\u8eab\u7684\u5408\u89c4\u57fa\u7ebf\u4e0e\u534f\u4f5c\u75db\u70b9\uff0c\u65b9\u80fd\u5728\u8fd9\u573a\u6570\u5b57\u5316\u5347\u7ea7\u4e2d\u627e\u5230\u6700\u503c\u5f97\u5c1d\u8bd5\u7684\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\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%E4%B8%8D%E8%83%BD%E5%8F%AA%E7%94%A8%E9%80%9A%E7%94%A8%E5%9E%8B%E9%A1%B9%E7%9B%AE%E7%AE%A1%E7%90%86%E5%B7%A5%E5%85%B7%E5%81%9A%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u4e0d\u80fd\u53ea\u7528\u901a\u7528\u578b\u9879\u76ee\u7ba1\u7406\u5de5\u5177\u505a\u9700\u6c42\u7ba1\u7406\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u5c24\u5176\u662f\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u9886\u57df\uff0c\u9762\u4e34\u4e25\u683c\u7684\u6cd5\u89c4\u7ea6\u675f\uff08\u5982FDA 21 CFR Part 11\u3001IEC 62304\uff09\uff0c\u8981\u6c42\u9700\u6c42\u5177\u5907\u7aef\u5230\u7aef\u7684\u53ef\u8ffd\u6eaf\u6027\u3001\u4e25\u683c\u7684\u53d8\u66f4\u63a7\u5236\u4ee5\u53ca\u7535\u5b50\u7b7e\u540d\u7b49\u5408\u89c4\u80fd\u529b\u3002\u901a\u7528\u578b\u5de5\u5177\u901a\u5e38\u7f3a\u4e4f\u8fd9\u4e9b\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u7279\u6027\uff0c\u5f3a\u884c\u6539\u9020\u4e0d\u4ec5\u6210\u672c\u9ad8\uff0c\u4e14\u5728\u5ba1\u8ba1\u65f6\u5b58\u5728\u4e0d\u901a\u8fc7\u7684\u98ce\u9669\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E5%A6%82%E4%BD%95%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%E9%9C%80%E6%B1%82%EF%BC%9F\"><\/span>Jira\u5982\u4f55\u6ee1\u8db3\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u7684\u5408\u89c4\u9700\u6c42\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Jira\u539f\u751f\u529f\u80fd\u504f\u5411\u654f\u6377\u5f00\u53d1\u4e0e\u901a\u7528\u4efb\u52a1\u7ba1\u7406\uff0c\u8981\u6ee1\u8db3\u533b\u7597\u5408\u89c4\u9700\u6c42\uff0c\u901a\u5e38\u9700\u8981\u7ed3\u5408Marketplace\u4e0a\u7684\u7b2c\u4e09\u65b9\u63d2\u4ef6\uff08\u5982Xray\u7528\u4e8e\u6d4b\u8bd5\u8ffd\u6eaf\uff0cComala\u6587\u6863\u7ba1\u7406\u7528\u4e8e\u63a7\u5236\u6587\u6863\u5ba1\u6279\uff09\uff0c\u901a\u8fc7\u914d\u7f6e\u5de5\u4f5c\u6d41\u4e0e\u6743\u9650\u6765\u5b9e\u73b0\u7535\u5b50\u7b7e\u540d\u548c\u9700\u6c42\u8ffd\u6eaf\u94fe\uff0c\u9002\u5408\u6709\u4e00\u5b9a\u8fd0\u7ef4\u914d\u7f6e\u80fd\u529b\u7684\u56e2\u961f\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%E5%93%AA%E6%AC%BE%E5%B7%A5%E5%85%B7%E6%9B%B4%E5%90%88%E9%80%82%EF%BC%9F\"><\/span>\u5bf9\u4e8e\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\uff0c\u54ea\u6b3e\u5de5\u5177\u66f4\u5408\u9002\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\u5982\u679c\u5728\u65e9\u671f\u5408\u89c4\u538b\u529b\u76f8\u5bf9\u8f83\u5c0f\uff0c\u66f4\u770b\u91cd\u56e2\u961f\u7684\u654f\u6377\u534f\u540c\u4e0e\u5feb\u901f\u8fed\u4ee3\uff0cONES\u548cTower\u662f\u8f83\u597d\u7684\u5207\u5165\u70b9\u3002ONES\u5728\u9700\u6c42\u7ed3\u6784\u5316\u4e0e\u7814\u53d1\u6d41\u7a0b\u95ed\u73af\u4e0a\u8868\u73b0\u66f4\u4f18\uff0c\u800cTower\u5728\u8f7b\u91cf\u4efb\u52a1\u534f\u540c\u4e0a\u4e0a\u624b\u6781\u5feb\uff1b\u82e5\u56e2\u961f\u5177\u5907\u56fd\u9645\u5316\u80cc\u666f\u4e14\u91c7\u7528\u654f\u6377\u5b9e\u8df5\uff0cJira\u4e5f\u662f\u5e38\u89c1\u9009\u62e9\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_ALM%E5%92%8CVisure_Requirements%E5%9C%A8%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E7%9A%84%E6%A0%B8%E5%BF%83%E5%B7%AE%E5%BC%82%E6%98%AF%E4%BB%80%E4%B9%88%EF%BC%9F\"><\/span>Helix ALM\u548cVisure Requirements\u5728\u533b\u7597\u884c\u4e1a\u7684\u6838\u5fc3\u5dee\u5f02\u662f\u4ec0\u4e48\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e24\u8005\u90fd\u662f\u4e13\u4e1a\u7ea7ALM\/\u9700\u6c42\u7ba1\u7406\u5de5\u5177\uff0c\u4f46Helix ALM\u5728\u9700\u6c42\u3001\u6d4b\u8bd5\u4e0e\u4ee3\u7801\u7684\u5f3a\u5173\u8054\u8ffd\u6eaf\u53ca\u5b9e\u65f6\u540c\u6b65\u65b9\u9762\u8868\u73b0\u7a81\u51fa\uff0c\u9002\u5408\u5bf9\u6d4b\u8bd5\u9a8c\u8bc1\u95ed\u73af\u8981\u6c42\u6781\u9ad8\u7684\u7cfb\u7edf\uff1bVisure Requirements\u5219\u5728\u9700\u6c42\u5de5\u7a0b\u672c\u8eab\uff08\u5982\u9700\u6c42\u590d\u7528\u3001\u591a\u6807\u51c6\u5408\u89c4\u6a21\u677f\u5982IEC 62304\u5f00\u7bb1\u5373\u7528\uff09\u4e0a\u66f4\u4e3a\u4e13\u7cbe\uff0c\u66f4\u4fa7\u91cd\u4e8e\u9700\u6c42\u5b9a\u4e49\u4e0e\u5408\u89c4\u6587\u6863\u751f\u6210\u7684\u6548\u7387\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\u600e\u4e48\u9009\uff1f\u672c\u6587\u57fa\u4e8e\u7edf\u4e00\u6d4b\u8bc4\u6846\u67b6\uff0c\u5bf96\u6b3e\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\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\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5","_yoast_wpseo_title":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\uff1f\u6df1\u5ea6\u6d4b\u8bc4\u4e0e\u63a8\u8350","_yoast_wpseo_metadesc":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\u600e\u4e48\u9009\uff1f\u672c\u6587\u57fa\u4e8e\u7edf\u4e00\u6d4b\u8bc4\u6846\u67b6\uff0c\u5bf96\u6b3e\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\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-1635","post","type-post","status-publish","format-standard","hentry","category-tools"],"yoast_head":"<!-- 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