{"id":3190,"date":"2026-06-24T10:18:13","date_gmt":"2026-06-24T02:18:13","guid":{"rendered":"https:\/\/wiz.cn\/blog\/?p=3190"},"modified":"2026-06-24T10:18:13","modified_gmt":"2026-06-24T02:18:13","slug":"tool-review-guide-best-302","status":"publish","type":"post","link":"https:\/\/wiz.cn\/blog\/tools-guides\/tool-review-guide-best-302","title":{"rendered":"2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\uff1f\u9009\u578b\u6307\u5357\u4e0e\u6d4b\u8bc4"},"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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#%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-guides\/tool-review-guide-best-302\/#%E5%85%AD%E5%A4%A7%E4%B8%BB%E6%B5%81%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%A0%B8%E5%BF%83%E4%BC%98%E5%8A%BF%E4%B8%80%E8%A7%88\" >\u516d\u5927\u4e3b\u6d41\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u6838\u5fc3\u4f18\u52bf\u4e00\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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#Jama_Connect\" >Jama Connect<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/wiz.cn\/blog\/tools-guides\/tool-review-guide-best-302\/#%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%9C%AA%E6%9D%A5%E5%B1%95%E6%9C%9B\" >\u9009\u578b\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-guides\/tool-review-guide-best-302\/#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-guides\/tool-review-guide-best-302\/#%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E4%B8%BA%E4%BB%80%E4%B9%88%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E9%9C%80%E6%B1%82%E7%9A%84%E5%8F%AF%E8%BF%BD%E6%BA%AF%E6%80%A7%EF%BC%9F\" >\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u7279\u522b\u5f3a\u8c03\u9700\u6c42\u7684\u53ef\u8ffd\u6eaf\u6027\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-guides\/tool-review-guide-best-302\/#Jira%E6%98%AF%E5%90%A6%E9%80%82%E5%90%88%E7%94%A8%E4%BA%8E%E9%AB%98%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%E7%9A%84%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%A0%94%E5%8F%91%EF%BC%9F\" >Jira\u662f\u5426\u9002\u5408\u7528\u4e8e\u9ad8\u5408\u89c4\u8981\u6c42\u7684\u533b\u7597\u5668\u68b0\u7814\u53d1\uff1f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/wiz.cn\/blog\/tools-guides\/tool-review-guide-best-302\/#Helix_ALM%E5%92%8CJama_Connect%E5%9C%A8%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E5%BA%94%E7%94%A8%E4%B8%AD%E6%9C%89%E4%BD%95%E6%A0%B8%E5%BF%83%E5%B7%AE%E5%BC%82%EF%BC%9F\" >Helix ALM\u548cJama Connect\u5728\u533b\u7597\u884c\u4e1a\u5e94\u7528\u4e2d\u6709\u4f55\u6838\u5fc3\u5dee\u5f02\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-guides\/tool-review-guide-best-302\/#%E5%B0%8F%E5%9E%8B%E6%95%B0%E5%AD%97%E5%81%A5%E5%BA%B7%E5%9B%A2%E9%98%9F%E5%BA%94%E5%A6%82%E4%BD%95%E5%B9%B3%E8%A1%A1%E9%A2%84%E7%AE%97%E4%B8%8E%E5%90%88%E8%A7%84%E9%9C%80%E6%B1%82%EF%BC%9F\" >\u5c0f\u578b\u6570\u5b57\u5065\u5eb7\u56e2\u961f\u5e94\u5982\u4f55\u5e73\u8861\u9884\u7b97\u4e0e\u5408\u89c4\u9700\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%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\u4ea7\u54c1\u7814\u53d1\u9762\u4e34\u7740\u66f4\u4e25\u82db\u7684\u5408\u89c4\u8981\u6c42\u4e0e\u66f4\u590d\u6742\u7684\u8de8\u90e8\u95e8\u534f\u540c\u3002\u4ece\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5230\u4e92\u8054\u7f51\u533b\u9662\u5e73\u53f0\uff0c\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u5df2\u6210\u4e3a\u51b3\u5b9a\u4ea7\u54c1\u4ea4\u4ed8\u8d28\u91cf\u4e0e\u5408\u89c4\u98ce\u9669\u7684\u6838\u5fc3\u8981\u7d20\u3002\u9762\u5bf9\u65e5\u76ca\u4e25\u683c\u7684FDA\u3001MDR\u53caNMPA\u7b49\u76d1\u7ba1\u89c4\u8303\uff0c\u56e2\u961f\u4e0d\u4ec5\u9700\u8981\u6355\u6349\u77ac\u606f\u4e07\u53d8\u7684\u4e34\u5e8a\u4e0e\u4e1a\u52a1\u9700\u6c42\uff0c\u66f4\u8981\u5b9e\u73b0\u9700\u6c42\u7684\u5168\u751f\u547d\u5468\u671f\u53ef\u8ffd\u6eaf\u3002\u90a3\u4e48\uff0c\u5728\u4f17\u591a\u9879\u76ee\u7ba1\u7406\u4e0e\u7814\u53d1\u5de5\u5177\u4e2d\uff0c<strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5<\/strong>\uff1f\u672c\u6587\u5c06\u4e3a\u60a8\u63d0\u4f9b\u4e00\u4efd\u8be6\u5c3d\u7684\u9009\u578b\u6307\u5357\u4e0e\u6d4b\u8bc4\u53c2\u8003\uff0c\u52a9\u60a8\u7cbe\u51c6\u5339\u914d\u9002\u5408\u7684\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\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\u770b\u901a\u7528\u9879\u76ee\u7684\u7ba1\u7406\u6548\u7387\uff0c\u66f4\u9700\u805a\u7126\u884c\u4e1a\u7279\u6709\u7684\u5408\u89c4\u4e0e\u534f\u540c\u58c1\u5792\u3002\u6211\u4eec\u57282026\u5e74\u7684\u9009\u578b\u4e2d\uff0c\u5efa\u8bae\u56f4\u7ed5\u4ee5\u4e0b\u56db\u5927\u6838\u5fc3\u7ef4\u5ea6\u5c55\u5f00\uff1a<\/p>\n<ul>\n<li><strong>\u5408\u89c4\u4e0e\u53ef\u8ffd\u6eaf\u6027<\/strong>\uff1a\u7cfb\u7edf\u662f\u5426\u652f\u6301\u9700\u6c42\u3001\u8bbe\u8ba1\u3001\u6d4b\u8bd5\u53ca\u53d1\u5e03\u4e4b\u95f4\u7684\u7aef\u5230\u7aef\u53cc\u5411\u8ffd\u6eaf\uff0c\u80fd\u5426\u4e00\u952e\u751f\u6210\u7b26\u5408\u5ba1\u8ba1\u8981\u6c42\u7684\u8ffd\u6eaf\u77e9\u9635\u3002<\/li>\n<li><strong>\u884c\u4e1a\u5b9a\u5236\u4e0e\u6269\u5c55\u6027<\/strong>\uff1a\u662f\u5426\u63d0\u4f9b\u533b\u7597\u884c\u4e1a\u9879\u76ee\u6a21\u677f\uff0c\u80fd\u5426\u7075\u6d3b\u914d\u7f6e\u5ba1\u6279\u6d41\u4e0e\u5b57\u6bb5\u4ee5\u6ee1\u8db3\u4e0d\u540c\u533b\u7597\u5668\u68b0\u6216\u8f6f\u4ef6\u7684\u76d1\u7ba1\u5206\u7c7b\u8981\u6c42\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u534f\u540c\u80fd\u529b<\/strong>\uff1a\u533b\u7597\u4ea7\u54c1\u5f80\u5f80\u6d89\u53ca\u4e34\u5e8a\u4e13\u5bb6\u3001\u6cd5\u89c4\u6ce8\u518c\u4e0e\u7814\u53d1\u56e2\u961f\uff0c\u7cfb\u7edf\u662f\u5426\u652f\u6301\u8de8\u9886\u57df\u7684\u9ad8\u6548\u6c9f\u901a\u4e0e\u6743\u9650\u9694\u79bb\u3002<\/li>\n<li><strong>\u6570\u636e\u5b89\u5168\u4e0e\u6743\u9650\u7ba1\u63a7<\/strong>\uff1a\u662f\u5426\u5177\u5907\u4f01\u4e1a\u7ea7\u7684\u6570\u636e\u52a0\u5bc6\u3001\u7ec6\u7c92\u5ea6\u6743\u9650\u63a7\u5236\uff0c\u4ee5\u4fdd\u969c\u60a3\u8005\u9690\u79c1\u4e0e\u6838\u5fc3\u8d44\u4ea7\u5b89\u5168\u3002<\/li>\n<\/ul>\n<p>\u57fa\u4e8e\u4e0a\u8ff0\u7ef4\u5ea6\uff0c\u6211\u4eec\u5bf9\u5e02\u9762\u4e3b\u6d41\u5de5\u5177\u8fdb\u884c\u4e86\u7cfb\u7edf\u5316\u68b3\u7406\uff0c\u5f62\u6210\u5982\u4e0b\u6d4b\u8bc4\u7ef4\u5ea6\u5bf9\u7167\u8868\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6d4b\u8bc4\u7ef4\u5ea6<\/th>\n<th>\u8bc4\u4f30\u91cd\u70b9<\/th>\n<th>\u884c\u4e1a\u5173\u8054\u5ea6<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027<\/td>\n<td>\u9700\u6c42-\u4ee3\u7801-\u6d4b\u8bd5\u7528\u4f8b\u53cc\u5411\u5173\u8054\u4e0e\u8ffd\u6eaf\u77e9\u9635\u5bfc\u51fa<\/td>\n<td>\u6781\u9ad8\uff08\u5408\u89c4\u5ba1\u8ba1\u521a\u9700\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5408\u89c4\u6a21\u677f\u4e0e\u57fa\u7ebf<\/td>\n<td>\u5185\u7f6e\u533b\u7597\u6cd5\u89c4\u6a21\u677f\u3001\u9700\u6c42\u57fa\u7ebf\u51bb\u7ed3\u4e0e\u53d8\u66f4\u63a7\u5236<\/td>\n<td>\u9ad8\uff08\u964d\u672c\u589e\u6548\u5173\u952e\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u8de8\u90e8\u95e8\u534f\u4f5c<\/td>\n<td>\u4e34\u5e8a\u3001QA\u3001\u7814\u53d1\u591a\u89d2\u8272\u89c6\u56fe\u4e0e\u4fe1\u606f\u540c\u6b65<\/td>\n<td>\u4e2d\u9ad8\uff08\u6253\u7834\u4fe1\u606f\u5b64\u5c9b\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u5168\u4e0e\u6743\u9650<\/td>\n<td>\u7ec6\u7c92\u5ea6\u89d2\u8272\u6743\u9650\u3001\u64cd\u4f5c\u65e5\u5fd7\u4e0e\u6570\u636e\u9694\u79bb<\/td>\n<td>\u6781\u9ad8\uff08\u9690\u79c1\u4e0e\u5408\u89c4\uff09<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"%E5%85%AD%E5%A4%A7%E4%B8%BB%E6%B5%81%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E6%A0%B8%E5%BF%83%E4%BC%98%E5%8A%BF%E4%B8%80%E8%A7%88\"><\/span>\u516d\u5927\u4e3b\u6d41\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u6838\u5fc3\u4f18\u52bf\u4e00\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\u516d\u6b3e\u5907\u53d7\u5173\u6ce8\u7684\u5de5\u5177\u8fdb\u884c\u5168\u666f\u5f0f\u626b\u63cf\uff0c\u5e2e\u52a9\u60a8\u5feb\u901f\u5efa\u7acb\u521d\u6b65\u8ba4\u77e5\uff1a<\/p>\n<ol>\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\u6c60\u7ba1\u7406\uff0c\u652f\u6301\u7075\u6d3b\u7684\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\u4e0e\u5c5e\u6027\u914d\u7f6e\uff0c\u9002\u5408\u6ce8\u91cd\u672c\u571f\u5316\u670d\u52a1\u4e0e\u654f\u6377\u534f\u540c\u7684\u533b\u7597\u7814\u53d1\u56e2\u961f\u3002<\/li>\n<li><strong>Tower<\/strong>\uff1a\u4ee5\u8f7b\u91cf\u5316\u548c\u6613\u7528\u6027\u8457\u79f0\uff0c\u64c5\u957f\u8de8\u56e2\u961f\u4efb\u52a1\u534f\u540c\uff0c\u9002\u5408\u533b\u7597\u5065\u5eb7\u4e1a\u52a1\u4fa7\u4e0e\u7814\u53d1\u4fa7\u7684\u8f7b\u91cf\u7ea7\u9700\u6c42\u5bf9\u63a5\u4e0e\u8fdb\u5ea6\u8ffd\u8e2a\u3002<\/li>\n<li><strong>Jira<\/strong>\uff1a\u5168\u7403\u654f\u6377\u5f00\u53d1\u6807\u6746\uff0c\u62e5\u6709\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u901a\u8fc7\u6269\u5c55\u53ef\u6ee1\u8db3\u57fa\u7840\u7684\u8ffd\u6eaf\u9700\u6c42\uff0c\u9002\u5408\u6280\u672f\u5e95\u8574\u6df1\u539a\u4e14\u5177\u5907\u4e8c\u6b21\u5f00\u53d1\u80fd\u529b\u7684\u56e2\u961f\u3002<\/li>\n<li><strong>Azure DevOps<\/strong>\uff1a\u5fae\u8f6f\u751f\u6001\u6838\u5fc3\uff0c\u63d0\u4f9b\u4ece\u9700\u6c42\u5230CI\/CD\u7684\u5168\u94fe\u8def\u7ba1\u7406\uff0c\u4e0e\u4e91\u57fa\u7840\u8bbe\u65bd\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u9002\u5408\u5927\u578b\u533b\u7597\u4e91\u5e73\u53f0\u53caSaaS\u5316\u5065\u5eb7\u5e94\u7528\u56e2\u961f\u3002<\/li>\n<li><strong>Helix ALM<\/strong>\uff1a\u4e13\u4e3a\u9ad8\u5408\u89c4\u884c\u4e1a\u8bbe\u8ba1\u7684\u751f\u547d\u5468\u671f\u7ba1\u7406\u5de5\u5177\uff0c\u63d0\u4f9b\u5f00\u7bb1\u5373\u7528\u7684\u7aef\u5230\u7aef\u8ffd\u6eaf\u4e0e\u6587\u6863\u63a7\u5236\uff0c\u662f\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u5f00\u53d1\u7684\u786c\u6838\u5408\u89c4\u4e4b\u9009\u3002<\/li>\n<li><strong>Jama Connect<\/strong>\uff1a\u805a\u7126\u590d\u6742\u7cfb\u7edf\u4e0e\u5408\u89c4\u9700\u6c42\uff0c\u64c5\u957f\u98ce\u9669\u7ba1\u7406\u4e0e\u9700\u6c42\u95ed\u73af\uff0c\u5728\u533b\u7597\u8bbe\u5907\u4e0e\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u9886\u57df\u62e5\u6709\u6210\u719f\u7684\u884c\u4e1a\u89e3\u51b3\u65b9\u6848\u3002<\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"2026%E5%B9%B4%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E9%9C%80%E6%B1%82%E7%AE%A1%E7%90%86%E7%B3%BB%E7%BB%9F%E5%93%AA%E4%BA%9B%E5%80%BC%E5%BE%97%E5%B0%9D%E8%AF%95%E6%B7%B1%E5%BA%A6%E6%B5%8B%E8%AF%84\"><\/span>2026\u5e74\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\u6df1\u5ea6\u6d4b\u8bc4<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"ONES\"><\/span><a href=\"https:\/\/ones.cn\/\" target=\"_blank\" rel=\"noopener noreferrer\">ONES<\/a><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5<\/strong>\uff1a\u4f5c\u4e3a\u56fd\u4ea7\u7814\u53d1\u7ba1\u7406\u5e73\u53f0\u7684\u6807\u6746\uff0cONES\u57282026\u5e74\u5df2\u6784\u5efa\u8d77\u8986\u76d6\u9879\u76ee\u5168\u751f\u547d\u5468\u671f\u7684\u7ba1\u7406\u95ed\u73af\u3002\u5176\u5e95\u5c42\u7684\u7075\u6d3b\u914d\u7f6e\u5f15\u64ce\u4e0e\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684\u6d41\u7a0b\u67b6\u6784\uff0c\u4f7f\u5176\u4e0d\u518d\u5c40\u9650\u4e8e\u901a\u7528\u8f6f\u4ef6\u7814\u53d1\uff0c\u800c\u662f\u80fd\u591f\u6df1\u5ea6\u4e0b\u6c89\u81f3\u533b\u7597\u5065\u5eb7\u7b49\u5f3a\u5408\u89c4\u3001\u9ad8\u95e8\u69db\u884c\u4e1a\uff0c\u4e3a\u4f01\u4e1a\u63d0\u4f9b\u575a\u5b9e\u7684\u9700\u6c42\u7ba1\u7406\u6570\u5b57\u57fa\u5ea7\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1aONES\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\u7684\u9700\u6c42\u7ba1\u7406\u9002\u914d\u6027\uff0c\u96c6\u4e2d\u4f53\u73b0\u5728\u5bf9\u5408\u89c4\u4e0e\u534f\u540c\u7684\u53cc\u91cd\u8d4b\u80fd\u4e0a\uff1a<\/p>\n<ul>\n<li><strong>\u5f3a\u5408\u89c4\u9a71\u52a8\u7684\u9700\u6c42\u5168\u94fe\u8def\u8ffd\u6eaf<\/strong>\uff1a\u652f\u6301\u4ece\u5e02\u573a\u5408\u89c4\u9700\u6c42\u5230\u7cfb\u7edf\u7ea7\u3001\u6a21\u5757\u7ea7\u9700\u6c42\u7684\u9010\u5c42\u62c6\u89e3\u4e0e\u53cc\u5411\u5173\u8054\u3002\u5728\u5e94\u5bf9NMPA\u6216FDA\u5ba1\u8ba1\u65f6\uff0c\u53ef\u4e00\u952e\u8f93\u51fa\u5b8c\u6574\u7684\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635\uff0c\u786e\u4fdd\u6bcf\u6761\u4e34\u5e8a\u9700\u6c42\u5747\u6709\u660e\u786e\u7684\u5b9e\u73b0\u4e0e\u9a8c\u8bc1\u95ed\u73af\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u4e34\u5e8a\u4e0e\u7814\u53d1\u56e2\u961f\u7684\u534f\u540c\u9694\u79bb<\/strong>\uff1a\u533b\u7597\u9879\u76ee\u5e38\u6d89\u53ca\u4e34\u5e8a\u4e13\u5bb6\u4e0e\u7814\u53d1\u4eba\u5458\u3002ONES\u652f\u6301\u5728\u540c\u4e00\u9879\u76ee\u5185\u6309\u89d2\u8272\u914d\u7f6e\u89c6\u56fe\u4e0e\u5b57\u6bb5\u6743\u9650\uff0c\u5b9e\u73b0\u4e34\u5e8a\u8bed\u8a00\u5230\u6280\u672f\u8bed\u8a00\u7684\u5e73\u6ed1\u8f6c\u5316\u4e0e\u4fe1\u606f\u7cbe\u51c6\u9694\u79bb\uff0c\u964d\u4f4e\u6c9f\u901a\u58c1\u5792\u3002<\/li>\n<li><strong>\u8d28\u91cf\u4f53\u7cfb\u6587\u4ef6\u7684\u5d4c\u5165\u5f0f\u7ba1\u63a7<\/strong>\uff1a\u9700\u6c42\u6c60\u5185\u53ef\u6df1\u5ea6\u5173\u8054\u8bbe\u8ba1\u89c4\u8303\u4e0e\u6d4b\u8bd5\u7528\u4f8b\uff0c\u786e\u4fdd\u9700\u6c42\u53d8\u66f4\u81ea\u52a8\u89e6\u53d1\u8d28\u91cf\u5f71\u54cd\u5206\u6790\uff0c\u4f7f\u8d28\u91cf\u5408\u89c4\u52a8\u4f5c\u524d\u7f6e\uff0c\u800c\u975e\u4e8b\u540e\u8865\u6551\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9ad8\u5ea6\u9002\u914d\u4e8e\u533b\u7597\u5668\u68b0\u6570\u5b57\u5316\u8f6f\u4ef6\u3001\u4e92\u8054\u7f51\u533b\u9662\u5e73\u53f0\u53ca\u533a\u57df\u533b\u7597\u4fe1\u606f\u7cfb\u7edf\u7684\u7814\u53d1\u56e2\u961f\u3002\u5c24\u5176\u5f53\u7ec4\u7ec7\u9762\u4e34\u4e25\u82db\u7684\u5408\u89c4\u5ba1\u8ba1\u538b\u529b\uff0c\u4e14\u4e9f\u9700\u6253\u7834\u4e34\u5e8a\u4e1a\u52a1\u4fa7\u4e0e\u4ea7\u7814\u4fa7\u534f\u540c\u58c1\u5792\u65f6\uff0cONES\u80fd\u63d0\u4f9b\u4f53\u7cfb\u5316\u7684\u843d\u5730\u652f\u6491\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1aONES\u7684\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5176\u5c06\u201c\u5408\u89c4\u7ba1\u63a7\u201d\u65e0\u7f1d\u878d\u5165\u201c\u654f\u6377\u4ea4\u4ed8\u201d\u4e4b\u4e2d\u3002\u9009\u578b\u4eba\u5458\u53ef\u4f18\u5148\u5229\u7528\u5176\u9879\u76ee\u6a21\u677f\u5feb\u901f\u642d\u5efa\u7b26\u5408\u533b\u7597\u8d28\u91cf\u4f53\u7cfb\u7684\u57fa\u7ebf\uff0c\u5e76\u501f\u52a9\u81ea\u52a8\u5316\u5de5\u4f5c\u6d41\u5c06\u9700\u6c42\u8bc4\u5ba1\u4e0e\u5408\u89c4\u786e\u8ba4\u56fa\u5316\u4e3a\u5fc5\u7ecf\u8282\u70b9\uff0c\u4ece\u800c\u5728\u4fdd\u969c\u533b\u7597\u5b89\u5168\u7684\u524d\u63d0\u4e0b\uff0c\u5b9e\u73b0\u7814\u53d1\u6548\u80fd\u7684\u5b9e\u8d28\u6027\u8dc3\u5347\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>\u4f5c\u4e3a\u56fd\u5185\u8001\u724c\u7684\u8f7b\u91cf\u7ea7\u534f\u4f5c\u5e73\u53f0\uff0cTower\u4ee5\u7b80\u6d01\u7684\u770b\u677f\u4e0e\u5217\u8868\u903b\u8f91\u89c1\u957f\uff0c\u957f\u671f\u670d\u52a1\u4e8e\u4e92\u8054\u7f51\u53ca\u4e2d\u5c0f\u578b\u56e2\u961f\u7684\u65e5\u5e38\u4efb\u52a1\u6d41\u8f6c\u3002\u5176\u8bbe\u8ba1\u54f2\u5b66\u504f\u5411\u4e8e\u654f\u6377\u4e0e\u6241\u5e73\u5316\u7ba1\u7406\uff0c\u4e0a\u624b\u95e8\u69db\u6781\u4f4e\uff0c\u4f46\u5728\u9762\u5bf9\u5f3a\u5408\u89c4\u3001\u957f\u5468\u671f\u53ca\u590d\u6742\u5173\u8054\u7684\u5de5\u7a0b\u5316\u7ba1\u7406\u65f6\uff0c\u5f80\u5f80\u663e\u5f97\u7eb5\u6df1\u4e0d\u8db3\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong>Tower\u5728\u533b\u7597\u5065\u5eb7\u9886\u57df\u7684\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u76f8\u5bf9\u57fa\u7840\uff0c\u66f4\u4fa7\u91cd\u4e8e\u4e1a\u52a1\u4fa7\u7684\u8f7b\u91cf\u534f\u4f5c\u800c\u975e\u5de5\u7a0b\u7ea7\u7ba1\u63a7\uff0c\u4e3b\u8981\u4f53\u73b0\u5728\u4ee5\u4e0b\u4e24\u70b9\uff1a<\/p>\n<ul>\n<li><strong>\u8f7b\u91cf\u7ea7\u9700\u6c42\u6d41\u8f6c\u4e0e\u770b\u677f\u8ffd\u8e2a\uff1a<\/strong>\u652f\u6301\u901a\u8fc7\u770b\u677f\u5feb\u901f\u5efa\u7acb\u9700\u6c42\u6c60\u4e0e\u72b6\u6001\u6d41\u8f6c\uff0c\u9002\u5408\u533b\u7597\u4ea7\u54c1\u8fd0\u8425\u3001\u5e02\u573a\u7b49\u975e\u6280\u672f\u56e2\u961f\u8fdb\u884c\u9700\u6c42\u6536\u96c6\u4e0e\u521d\u6b65\u6392\u671f\uff0c\u4f46\u5728\u5904\u7406\u9700\u6c42\u62c6\u89e3\u4e0e\u53cc\u5411\u8ffd\u6eaf\u65f6\u7f3a\u4e4f\u539f\u751f\u652f\u6301\u3002<\/li>\n<li><strong>\u8de8\u804c\u80fd\u4e1a\u52a1\u534f\u540c\uff1a<\/strong>\u901a\u8fc7\u9879\u76ee\u4e0e\u4efb\u52a1\u6307\u6d3e\uff0c\u80fd\u8f83\u597d\u5730\u62c9\u901a\u533b\u7597\u4ea7\u54c1\u7ecf\u7406\u3001\u5408\u89c4\u5ba1\u6838\u5458\u4e0e\u7814\u53d1\u4ee3\u8868\u7684\u65e5\u5e38\u6c9f\u901a\uff0c\u786e\u4fdd\u4e1a\u52a1\u8bc9\u6c42\u5728\u65e9\u671f\u9636\u6bb5\u7684\u900f\u660e\u5316\uff0c\u4f46\u65e0\u6cd5\u66ff\u4ee3\u4e13\u4e1a\u7684\u5408\u89c4\u4e0e\u9a8c\u8bc1\u7ba1\u7406\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u533b\u7597\u5065\u5eb7\u521d\u521b\u56e2\u961f\u3001\u504f\u5411C\u7aef\u5065\u5eb7\u7ba1\u7406\u7684\u8f7b\u91cf\u7ea7\u4ea7\u54c1\u7ebf\uff0c\u6216\u4f5c\u4e3a\u533b\u7597\u4e1a\u52a1\u8fd0\u8425\u4fa7\u7684\u9700\u6c42\u6536\u96c6\u4e0e\u5206\u53d1\u5165\u53e3\uff0c\u4e0d\u5efa\u8bae\u7528\u4e8e\u5f3a\u76d1\u7ba1\u7684\u533b\u7597\u5668\u68b0\u7814\u53d1\u6216\u9700\u6ee1\u8db3FDA\/CFDA\u5408\u89c4\u8ffd\u6eaf\u7684\u6838\u5fc3\u9879\u76ee\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5b66\u4e60\u6210\u672c\u6781\u4f4e\uff0c\u56e2\u961f\u53ef\u5728\u4e00\u4e24\u5929\u5185\u5feb\u901f\u8dd1\u901a\u8f7b\u91cf\u9700\u6c42\u6d41\u7a0b\uff1b\u754c\u9762\u4ea4\u4e92\u76f4\u89c2\uff0c\u975e\u6280\u672f\u80cc\u666f\u7684\u533b\u7597\u4e1a\u52a1\u4eba\u5458\u63a5\u53d7\u5ea6\u9ad8\uff1b\u8ba2\u9605\u6210\u672c\u8f83\u4f4e\uff0c\u9002\u5408\u9884\u7b97\u6709\u9650\u7684\u65e9\u671f\u56e2\u961f\u4f5c\u4e3a\u8fc7\u6e21\u6027\u5de5\u5177\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>\u5de5\u5177\u6982\u51b5\uff1a\u4f5c\u4e3a\u5168\u7403\u5e94\u7528\u6700\u5e7f\u6cdb\u7684\u654f\u6377\u9879\u76ee\u7ba1\u7406\u5de5\u5177\uff0cJira\u51ed\u501f\u5176\u9ad8\u5ea6\u53ef\u5b9a\u5236\u7684Issue\u8ffd\u8e2a\u673a\u5236\u4e0e\u4e30\u5bcc\u7684\u63d2\u4ef6\u751f\u6001\uff0c\u5728\u8f6f\u4ef6\u7814\u53d1\u9886\u57df\u786e\u7acb\u4e86\u4e0d\u53ef\u66ff\u4ee3\u7684\u5730\u4f4d\u3002\u5176\u5e95\u5c42\u903b\u8f91\u57fa\u4e8e\u5de5\u4f5c\u6d41\u5f15\u64ce\uff0c\u5141\u8bb8\u56e2\u961f\u6839\u636e\u81ea\u8eab\u6d41\u7a0b\u914d\u7f6e\u72b6\u6001\u6d41\u8f6c\u4e0e\u5b57\u6bb5\uff0c\u4f46\u5728\u9762\u5bf9\u5f3a\u5408\u89c4\u4e0e\u91cd\u8ffd\u6eaf\u7684\u884c\u4e1a\u65f6\uff0c\u5176\u6807\u51c6\u914d\u7f6e\u5f80\u5f80\u9700\u8981\u6df1\u5ea6\u6539\u9020\u4e0e\u5916\u90e8\u63d2\u4ef6\u8865\u9f50\u3002<\/p>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b\uff1a<\/p>\n<ul>\n<li>\u9700\u6c42\u5168\u751f\u547d\u5468\u671f\u8ffd\u6eaf\uff1a\u501f\u52a9Jira\u7684Issue\u5173\u8054\u4e0e\u81ea\u52a8\u5316\u94fe\u63a5\u673a\u5236\uff0c\u53ef\u5b9e\u73b0\u4eceEpic\u5411\u4e0b\u81f3Story\u4e0eBug\u7684\u5c42\u7ea7\u7a7f\u900f\u3002\u7ed3\u5408Zephyr\u7b49\u6d4b\u8bd5\u63d2\u4ef6\uff0c\u80fd\u521d\u6b65\u6784\u5efa\u201c\u9700\u6c42-\u4ee3\u7801-\u6d4b\u8bd5\u7528\u4f8b\u201d\u7684\u8ffd\u6eaf\u94fe\uff0c\u6ee1\u8db3\u533b\u7597\u8f6f\u4ef6\u57fa\u7840\u7684\u53ef\u5ba1\u8ba1\u6027\u8981\u6c42\u3002<\/li>\n<li>\u5408\u89c4\u5de5\u4f5c\u6d41\u5b9a\u5236\uff1a\u901a\u8fc7\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\u4e0e\u6743\u9650\u63a7\u5236\uff0c\u53ef\u5f3a\u5236\u5728\u9700\u6c42\u72b6\u6001\u6d41\u8f6c\u524d\u8bbe\u7f6e\u5fc5\u586b\u7684\u5408\u89c4\u68c0\u67e5\u5b57\u6bb5\uff08\u5982FDA\u9a8c\u8bc1\u7b7e\u6536\uff09\uff0c\u5c06\u90e8\u5206\u6cd5\u89c4\u8981\u6c42\u786c\u7f16\u7801\u81f3\u6d41\u7a0b\u8282\u70b9\u4e2d\uff0c\u51cf\u5c11\u4eba\u4e3a\u8fdd\u89c4\u98ce\u9669\u3002<\/li>\n<li>\u751f\u6001\u6269\u5c55\u4e0e\u6587\u6863\u96c6\u6210\uff1a\u4f9d\u9760\u5e9e\u5927\u7684Marketplace\u751f\u6001\uff0c\u53ef\u96c6\u6210Confluence\u5b9e\u73b0\u9700\u6c42\u8be6\u8ff0\u4e0e\u8bbe\u8ba1\u6587\u6863\u7684\u5173\u8054\uff0c\u5f25\u8865\u81ea\u8eab\u5728\u5bcc\u6587\u672c\u9700\u6c42\u63cf\u8ff0\u4e0a\u7684\u77ed\u677f\uff0c\u652f\u6491\u533b\u7597\u884c\u4e1a\u5bf9\u9700\u6c42\u4e0a\u4e0b\u6587\u5b8c\u6574\u6027\u7684\u8bc9\u6c42\u3002<\/li>\n<\/ul>\n<p>\u9002\u7528\u573a\u666f\uff1a\u9002\u5408\u5177\u5907\u8f83\u5f3aIT\u8fd0\u7ef4\u4e0e\u5b9a\u5236\u80fd\u529b\u7684\u533b\u7597\u79d1\u6280\u4f01\u4e1a\uff0c\u5c24\u5176\u662f\u7814\u53d1\u8d44\u6e90\u5145\u8db3\u3001\u4ee5\u654f\u6377\u8fed\u4ee3\u4e3a\u4e3b\u4e14\u9700\u5bf9\u63a5\u5927\u91cf\u7b2c\u4e09\u65b9\u7814\u53d1\u5de5\u5177\u7684\u56e2\u961f\u3002\u82e5\u7ec4\u7ec7\u7f3a\u4e4f\u4e13\u804cJira\u7ba1\u7406\u5458\u6216\u4e0d\u613f\u627f\u62c5\u9ad8\u6602\u7684\u63d2\u4ef6\u96c6\u6210\u6210\u672c\uff0c\u5176\u5408\u89c4\u843d\u5730\u95e8\u69db\u5c06\u663e\u8457\u5347\u9ad8\u3002<\/p>\n<p>\u4f18\u52bf\u4eae\u70b9\uff1a\u65e0\u53ef\u5339\u654c\u7684\u654f\u6377\u7ba1\u7406\u7075\u6d3b\u6027\u4e0e\u5168\u7403\u6700\u5e9e\u5927\u7684\u7814\u53d1\u5de5\u5177\u751f\u6001\u5708\uff1b\u5de5\u4f5c\u6d41\u5f15\u64ce\u6781\u5177\u6df1\u5ea6\uff0c\u80fd\u652f\u6491\u590d\u6742\u5ba1\u6279\u903b\u8f91\u7684\u786c\u6027\u7ba1\u63a7\uff1b\u4e0eConfluence\u6df1\u5ea6\u8054\u52a8\uff0c\u4e3a\u9700\u6c42\u4e0a\u4e0b\u6587\u63d0\u4f9b\u4f53\u7cfb\u5316\u627f\u8f7d\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\u4e86\u4ece\u9700\u6c42\u89c4\u5212\u5230\u4ee3\u7801\u90e8\u7f72\u7684\u7aef\u5230\u7aef\u5de5\u5177\u94fe\u3002\u5176\u5e95\u5c42\u67b6\u6784\u6210\u719f\uff0c\u652f\u6301\u9ad8\u5ea6\u5b9a\u5236\u5316\uff0c\u662f\u5927\u578b\u7ec4\u7ec7\u6784\u5efa\u7814\u53d1\u8fd0\u8425\u95ed\u73af\u7684\u5e95\u5c42\u57fa\u7840\u8bbe\u65bd\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u6838\u5fc3\u80fd\u529b\uff1a<\/strong><\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027\u4e0e\u5408\u89c4\u5ba1\u8ba1\uff1a<\/strong>\u901a\u8fc7Work Item\u8de8\u5c42\u7ea7\u94fe\u63a5\uff0c\u5b9e\u73b0\u4ece\u4e1a\u52a1\u9700\u6c42\u5230\u4ee3\u7801\u63d0\u4ea4\u3001\u6d4b\u8bd5\u7528\u4f8b\u7684\u53cc\u5411\u8ffd\u6eaf\uff0c\u6ee1\u8db3\u533b\u7597\u8f6f\u4ef6FDA 21 CFR Part 11\u7b49\u5408\u89c4\u5ba1\u8ba1\u5bf9\u53d8\u66f4\u5386\u53f2\u7684\u4e25\u82db\u8981\u6c42\u3002<\/li>\n<li><strong>\u4f01\u4e1a\u7ea7\u6743\u9650\u7ba1\u63a7\u4e0e\u6570\u636e\u9694\u79bb\uff1a<\/strong>\u4f9d\u6258Azure AD\u5b9e\u73b0\u7ec6\u7c92\u5ea6\u8eab\u4efd\u9a8c\u8bc1\uff0c\u652f\u6301\u9879\u76ee\u7ea7\u6570\u636e\u9694\u79bb\uff0c\u786e\u4fdd\u60a3\u8005\u9690\u79c1\u6570\u636e\u4e0e\u6838\u5fc3\u7814\u53d1\u8d44\u4ea7\u5728\u591a\u56e2\u961f\u534f\u4f5c\u4e2d\u7684\u5b89\u5168\u8fb9\u754c\u3002<\/li>\n<li><strong>\u81ea\u52a8\u5316\u5408\u89c4\u5de5\u4f5c\u6d41\uff1a<\/strong>\u7ed3\u5408Azure Pipelines\u4e0e\u5b9a\u5236\u5316\u72b6\u6001\u89c4\u5219\uff0c\u5f3a\u5236\u6267\u884c\u4ee3\u7801\u5ba1\u67e5\u4e0e\u5ba1\u6279\u95e8\u7981\uff0c\u5c06\u5408\u89c4\u68c0\u67e5\u5185\u5d4c\u4e8e\u7814\u53d1\u6d41\uff0c\u964d\u4f4e\u4eba\u4e3a\u8fdd\u89c4\u98ce\u9669\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u5408\u5df2\u878d\u5165\u5fae\u8f6f\u751f\u6001\u3001\u5bf9\u5408\u89c4\u5ba1\u8ba1\u4e0e\u6570\u636e\u5b89\u5168\u6709\u6781\u9ad8\u8981\u6c42\u7684\u5927\u578b\u533b\u7597\u8bbe\u5907\u5236\u9020\u5546\u6216\u533b\u7597SaaS\u4f01\u4e1a\uff0c\u5c24\u5176\u9002\u5408\u9700\u6253\u901a\u7814\u53d1\u4e0e\u8fd0\u7ef4\u58c1\u5792\u7684\u767e\u4eba\u4ee5\u4e0a\u89c4\u6a21\u56e2\u961f\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u751f\u6001\u96c6\u6210\u80fd\u529b\u5f3a\u5927\uff0c\u4e0eGitHub\u53ca\u5fae\u8f6f\u5b89\u5168\u5de5\u5177\u94fe\u65e0\u7f1d\u8854\u63a5\uff1b\u63d0\u4f9b\u79c1\u6709\u5316\u90e8\u7f72\u9009\u9879\uff0c\u6ee1\u8db3\u533b\u7597\u6570\u636e\u672c\u5730\u5316\u5f3a\u76d1\u7ba1\u8bc9\u6c42\uff1b\u5185\u7f6e\u654f\u6377\u4e0eCMMI\u6a21\u677f\uff0c\u517c\u987e\u7075\u6d3b\u4e0e\u89c4\u8303\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<\/strong>\uff1aHelix 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\u5728\u533b\u7597\u8bbe\u5907\u4e0e\u4f53\u5916\u8bca\u65ad\uff08IVD\uff09\u9886\u57df\u6df1\u8015\u591a\u5e74\u3002\u5b83\u5c06\u9700\u6c42\u7ba1\u7406\u3001\u6d4b\u8bd5\u8ffd\u8e2a\u4e0e\u7f3a\u9677\u95ed\u73af\u6df1\u5ea6\u6574\u5408\uff0c\u5176\u5e95\u5c42\u67b6\u6784\u5929\u7136\u5951\u5408\u5f3a\u76d1\u7ba1\u73af\u5883\u4e0b\u7684\u7814\u53d1\u903b\u8f91\uff0c\u662f\u4f20\u7edf\u91cd\u578b\u5408\u89c4\u4f53\u7cfb\u4e2d\u7684\u8001\u724c\u57fa\u77f3\u5de5\u5177\u3002<\/p>\n<p><strong>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u6838\u5fc3\u80fd\u529b<\/strong>\uff1a<\/p>\n<ul>\n<li><strong>\u7aef\u5230\u7aef\u5408\u89c4\u8ffd\u6eaf\u94fe<\/strong>\uff1a\u63d0\u4f9b\u4ece\u7528\u6237\u9700\u6c42\u5230\u7cfb\u7edf\u9700\u6c42\u3001\u6d4b\u8bd5\u7528\u4f8b\u53ca\u7f3a\u9677\u7684\u4e25\u683c\u53cc\u5411\u8ffd\u6eaf\uff0c\u8f7b\u677e\u6ee1\u8db3FDA 21 CFR Part 11\u4e0eIEC 62304\u7b49\u6cd5\u89c4\u5ba1\u8ba1\u8981\u6c42\uff0c\u786e\u4fdd\u65e0\u65ad\u94fe\u98ce\u9669\u3002<\/li>\n<li><strong>\u5185\u7f6e\u7535\u5b50\u7b7e\u540d\u4e0e\u5ba1\u8ba1\u8ffd\u8e2a<\/strong>\uff1a\u7cfb\u7edf\u7ea7\u539f\u751f\u652f\u6301\u5408\u89c4\u73af\u5883\u4e0b\u7684\u64cd\u4f5c\u7559\u75d5\u4e0e\u6743\u9650\u7ba1\u63a7\uff0c\u65e0\u9700\u989d\u5916\u63d2\u4ef6\u5373\u53ef\u5b9e\u73b0\u7b26\u5408\u89c4\u8303\u7684\u8bb0\u5f55\u4fdd\u5168\u4e0e\u9632\u7be1\u6539\u3002<\/li>\n<li><strong>\u57fa\u7ebf\u5316\u4e0e\u7248\u672c\u63a7\u5236<\/strong>\uff1a\u652f\u6301\u9700\u6c42\u6587\u6863\u4e0e\u6d4b\u8bd5\u8d44\u4ea7\u7684\u7ec6\u7c92\u5ea6\u57fa\u7ebf\u7ba1\u7406\uff0c\u5728\u533b\u7597\u4ea7\u54c1\u6f2b\u957f\u7684\u6ce8\u518c\u5468\u671f\u5185\uff0c\u53ef\u7cbe\u51c6\u56de\u6eaf\u4efb\u610f\u5386\u53f2\u8282\u70b9\u7684\u9700\u6c42\u5feb\u7167\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f<\/strong>\uff1a\u9ad8\u5ea6\u9002\u5408\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u3001\u690d\u5165\u5f0f\u8bbe\u5907\u6216IVD\u8f6f\u4ef6\u7684\u7814\u53d1\u56e2\u961f\uff0c\u7279\u522b\u662f\u9762\u4e34NMPA\u3001CE\u6216FDA\u4e25\u683c\u5ba1\u67e5\uff0c\u4e14\u5fc5\u987b\u8f93\u51fa\u5b8c\u6574\u5408\u89c4\u8bc1\u636e\u94fe\u7684\u9879\u76ee\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9<\/strong>\uff1a\u5176\u6700\u5927\u7684\u62a4\u57ce\u6cb3\u5728\u4e8e\u5f00\u7bb1\u5373\u7528\u7684\u5408\u89c4\u6846\u67b6\uff0c\u6781\u5927\u964d\u4f4e\u4e86\u5ba1\u8ba1\u5e94\u5bf9\u6210\u672c\u3002\u4f46\u9700\u5ba2\u89c2\u5ba1\u89c6\uff0c\u5176\u4ea4\u4e92\u4f53\u9a8c\u504f\u5411\u4f20\u7edf\u91cd\u578b\u8f6f\u4ef6\uff0c\u5b66\u4e60\u66f2\u7ebf\u9661\u5ced\uff0c\u4e14\u90e8\u7f72\u4e0e\u7ef4\u62a4\u6210\u672c\u8f83\u9ad8\u3002\u82e5\u56e2\u961f\u5408\u89c4\u5e95\u7ebf\u4e0d\u53ef\u59a5\u534f\u4e14\u5177\u5907\u5145\u8db3\u9884\u7b97\uff0cHelix ALM\u662f\u89c4\u907f\u5408\u89c4\u98ce\u9669\u7684\u6700\u7a33\u59a5\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\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=\"Jama_Connect\"><\/span>Jama Connect<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>\u5de5\u5177\u6982\u51b5\uff1a<\/strong>Jama Connect \u662f\u4e00\u6b3e\u4e13\u6ce8\u4e8e\u590d\u6742\u4ea7\u54c1\u4e0e\u7cfb\u7edf\u5de5\u7a0b\u7684\u7aef\u5230\u7aef\u9700\u6c42\u7ba1\u7406\u5e73\u53f0\u3002\u5b83\u4ee5\u9700\u6c42\u5b9a\u4e49\u3001\u8ffd\u8e2a\u4e0e\u9a8c\u8bc1\u4e3a\u6838\u5fc3\uff0c\u5728\u822a\u7a7a\u822a\u5929\u3001\u6c7d\u8f66\u53ca\u533b\u7597\u8bbe\u5907\u7b49\u5f3a\u76d1\u7ba1\u884c\u4e1a\u6df1\u8015\u591a\u5e74\uff0c\u81f4\u529b\u4e8e\u901a\u8fc7\u7ed3\u6784\u5316\u7684\u6570\u636e\u6d41\u4e0e\u98ce\u9669\u7ba1\u63a7\uff0c\u5e2e\u52a9\u56e2\u961f\u6784\u5efa\u5408\u89c4\u4e14\u9ad8\u8d28\u91cf\u7684\u5408\u89c4\u4ea7\u54c1\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\u8ffd\u6eaf\uff1a<\/strong>\u63d0\u4f9b\u4ece\u7528\u6237\u9700\u6c42\u3001\u7cfb\u7edf\u8bbe\u8ba1\u5230\u6d4b\u8bd5\u9a8c\u8bc1\u7684\u5168\u751f\u547d\u5468\u671f\u53cc\u5411\u94fe\u8def\uff0c\u786e\u4fdd\u533b\u7597\u8bbe\u5907\u7814\u53d1\u4e2d\u6bcf\u4e00\u9879\u8f93\u5165\u5747\u6709\u660e\u786e\u8f93\u51fa\u54cd\u5e94\uff0c\u8f7b\u677e\u5e94\u5bf9FDA\u7b49\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u67e5\u3002<\/li>\n<li><strong>\u5185\u7f6e\u5408\u89c4\u6846\u67b6\u6a21\u677f\uff1a<\/strong>\u9884\u7f6eIEC 62304\u3001ISO 13485\u7b49\u533b\u7597\u884c\u4e1a\u6838\u5fc3\u6807\u51c6\u6846\u67b6\uff0c\u56e2\u961f\u53ef\u76f4\u63a5\u590d\u7528\u7ed3\u6784\u5316\u6a21\u677f\uff0c\u5927\u5e45\u7f29\u77ed\u4f53\u7cfb\u6587\u4ef6\u642d\u5efa\u4e0e\u5408\u89c4\u8bc4\u5ba1\u5468\u671f\u3002<\/li>\n<li><strong>\u98ce\u9669\u7ba1\u7406\u4e0eFMEA\u96c6\u6210\uff1a<\/strong>\u5c06\u9700\u6c42\u4e0e\u98ce\u9669\u63a7\u5236\u63aa\u65bd\u6df1\u5ea6\u7ed1\u5b9a\uff0c\u652f\u6301\u5728\u9700\u6c42\u5c42\u7ea7\u76f4\u63a5\u5f00\u5c55\u5931\u6548\u6a21\u5f0f\u5206\u6790\uff0c\u786e\u4fdd\u98ce\u9669\u53ef\u8ffd\u6eaf\u4e14\u95ed\u73af\uff0c\u6ee1\u8db3\u533b\u7597\u4ea7\u54c1\u5b89\u5168\u6709\u6548\u6027\u7684\u4e25\u82db\u8981\u6c42\u3002<\/li>\n<\/ul>\n<p><strong>\u9002\u7528\u573a\u666f\uff1a<\/strong>\u9002\u7528\u4e8e\u533b\u7597\u5668\u68b0\u4e0e\u6570\u5b57\u7597\u6cd5\u7b49\u5f3a\u76d1\u7ba1\u3001\u9ad8\u5408\u89c4\u8981\u6c42\u7684\u8f6f\u786c\u4ef6\u7814\u53d1\u9879\u76ee\uff0c\u7279\u522b\u662f\u9700\u8981\u901a\u8fc7FDA\u3001CE\u8ba4\u8bc1\uff0c\u4e14\u56e2\u961f\u5177\u5907\u4e00\u5b9a\u7cfb\u7edf\u5de5\u7a0b\u4e0eV\u6a21\u578b\u5f00\u53d1\u57fa\u7840\u7684\u89c4\u6a21\u5316\u7ec4\u7ec7\u3002<\/p>\n<p><strong>\u4f18\u52bf\u4eae\u70b9\uff1a<\/strong>\u5176\u6838\u5fc3\u4f18\u52bf\u5728\u4e8e\u5c06\u5408\u89c4\u9a8c\u8bc1\u5185\u5316\u4e3a\u7cfb\u7edf\u539f\u751f\u80fd\u529b\uff0c\u800c\u975e\u4e8b\u540e\u8865\u5f55\u3002\u5bf9\u4e8e\u8ffd\u6c42\u5ba1\u8ba1\u96f6\u7f3a\u9677\u7684\u533b\u7597\u56e2\u961f\u800c\u8a00\uff0cJama Connect\u80fd\u6709\u6548\u89c4\u907f\u5408\u89c4\u7559\u75d5\u98ce\u9669\u3002\u4f46\u9700\u6ce8\u610f\uff0c\u5176\u5b66\u4e60\u66f2\u7ebf\u8f83\u9661\u5ced\uff0c\u4e14\u5bf9\u654f\u6377\u5f00\u53d1\u7684\u7075\u6d3b\u6027\u652f\u6301\u76f8\u5bf9\u6709\u9650\uff0c\u9009\u578b\u65f6\u9700\u8bc4\u4f30\u56e2\u961f\u5de5\u7a0b\u5316\u6210\u719f\u5ea6\u3002<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/blogcdn.ones-ai.cn\/blog\/uploads\/2026\/04\/8fd2c4b79fe5_Jama-Connect-\u4ea7\u54c1\u56fe-scaled-1.png\" alt=\"\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5+Jama Connect \u4ea7\u54c1\u56fe\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E9%80%89%E5%9E%8B%E5%BB%BA%E8%AE%AE%E4%B8%8E%E6%9C%AA%E6%9D%A5%E5%B1%95%E6%9C%9B\"><\/span>\u9009\u578b\u5efa\u8bae\u4e0e\u672a\u6765\u5c55\u671b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7efc\u5408\u6765\u770b\uff0c\u4e0d\u540c\u89c4\u6a21\u4e0e\u4e1a\u52a1\u7279\u6027\u7684\u533b\u7597\u5065\u5eb7\u56e2\u961f\uff0c\u5176\u9700\u6c42\u7ba1\u7406\u80fd\u529b\u7684\u5efa\u8bbe\u8def\u5f84\u5404\u4e0d\u76f8\u540c\u3002\u5bf9\u4e8e\u521d\u521b\u578b\u6570\u5b57\u533b\u7597\u56e2\u961f\uff0c<strong>ONES<\/strong>\u6216<strong>Tower<\/strong>\u80fd\u591f\u4ee5\u8f83\u4f4e\u7684\u5b66\u4e60\u6210\u672c\u5b9e\u73b0\u654f\u6377\u4ea4\u4ed8\uff1b\u5bf9\u4e8e\u5177\u5907\u4e00\u5b9a\u89c4\u6a21\u4e14\u5f3a\u4f9d\u8d56\u5fae\u8f6f\u6280\u672f\u6808\u7684\u56e2\u961f\uff0c<strong>Azure DevOps<\/strong>\u662f\u4e0d\u9519\u7684\u9009\u62e9\uff1b\u800c\u5bf9\u4e8e\u9700\u8981\u517c\u987e\u654f\u6377\u4e0e\u5b9a\u5236\u5316\u63d2\u4ef6\u7684\u56e2\u961f\uff0c<strong>Jira<\/strong>\u4f9d\u7136\u5177\u5907\u5f3a\u5927\u751f\u547d\u529b\u3002<\/p>\n<p>\u7136\u800c\uff0c\u82e5\u60a8\u7684\u4e1a\u52a1\u6d89\u53ca\u4e8c\u7c7b\/\u4e09\u7c7b\u533b\u7597\u5668\u68b0\u3001IVD\u6216\u53d7\u4e25\u82db\u76d1\u7ba1\u7684\u6838\u5fc3\u8bca\u7597\u7cfb\u7edf\uff0c<strong>Helix ALM<\/strong>\u4e0e<strong>Jama Connect<\/strong>\u5728\u7aef\u5230\u7aef\u8ffd\u6eaf\u3001\u98ce\u9669\u5206\u6790\u53ca\u5408\u89c4\u5ba1\u8ba1\u65b9\u9762\u7684\u539f\u751f\u4f18\u52bf\u5c06\u5927\u5e45\u964d\u4f4e\u5408\u89c4\u6210\u672c\u3002\u57282026\u5e74\uff0c\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u9700\u6c42\u7ba1\u7406\u7cfb\u7edf\u54ea\u4e9b\u503c\u5f97\u5c1d\u8bd5\uff0c\u6700\u7ec8\u53d6\u51b3\u4e8e\u60a8\u5bf9\u201c\u654f\u6377\u6548\u7387\u201d\u4e0e\u201c\u5408\u89c4\u6df1\u5ea6\u201d\u7684\u5e73\u8861\u3002\u5efa\u8bae\u56e2\u961f\u5728\u9009\u578b\u65f6\u660e\u786e\u81ea\u8eab\u6240\u5904\u7684\u53d1\u5c55\u9636\u6bb5\u4e0e\u76d1\u7ba1\u7ea2\u7ebf\uff0c\u901a\u8fc7\u6982\u5ff5\u9a8c\u8bc1\uff08POC\uff09\u9a8c\u8bc1\u7cfb\u7edf\u7684\u8ffd\u6eaf\u95ed\u73af\u80fd\u529b\uff0c\u4ece\u800c\u505a\u51fa\u6700\u4f18\u51b3\u7b56\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"FAQ%EF%BC%9A2026%E5%B9%B4%E5%B7%A5%E5%85%B7%E9%80%89%E5%9E%8B%E5%B8%B8%E8%A7%81%E9%97%AE%E9%A2%98\"><\/span>FAQ\uff1a2026\u5e74\u5de5\u5177\u9009\u578b\u5e38\u89c1\u95ee\u9898<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%96%97%E5%81%A5%E5%BA%B7%E8%A1%8C%E4%B8%9A%E4%B8%BA%E4%BB%80%E4%B9%88%E7%89%B9%E5%88%AB%E5%BC%BA%E8%B0%83%E9%9C%80%E6%B1%82%E7%9A%84%E5%8F%AF%E8%BF%BD%E6%BA%AF%E6%80%A7%EF%BC%9F\"><\/span>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\u4e3a\u4ec0\u4e48\u7279\u522b\u5f3a\u8c03\u9700\u6c42\u7684\u53ef\u8ffd\u6eaf\u6027\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u533b\u7597\u5065\u5eb7\u884c\u4e1a\uff08\u5c24\u5176\u662f\u533b\u7597\u5668\u68b0\u548c\u8bca\u7597\u8f6f\u4ef6\uff09\u53d7FDA\u3001NMPA\u7b49\u673a\u6784\u4e25\u683c\u76d1\u7ba1\u3002\u53ef\u8ffd\u6eaf\u6027\u786e\u4fdd\u4e86\u4ece\u4e34\u5e8a\u9700\u6c42\u3001\u4ea7\u54c1\u5b9a\u4e49\u3001\u4ee3\u7801\u5b9e\u73b0\u5230\u6d4b\u8bd5\u9a8c\u8bc1\u7684\u6bcf\u4e00\u6b65\u90fd\u6709\u636e\u53ef\u67e5\uff0c\u662f\u5e94\u5bf9\u5408\u89c4\u5ba1\u8ba1\u3001\u63a7\u5236\u4ea7\u54c1\u98ce\u9669\u3001\u4fdd\u969c\u60a3\u8005\u5b89\u5168\u7684\u786c\u6027\u8981\u6c42\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Jira%E6%98%AF%E5%90%A6%E9%80%82%E5%90%88%E7%94%A8%E4%BA%8E%E9%AB%98%E5%90%88%E8%A7%84%E8%A6%81%E6%B1%82%E7%9A%84%E5%8C%BB%E7%96%97%E5%99%A8%E6%A2%B0%E7%A0%94%E5%8F%91%EF%BC%9F\"><\/span>Jira\u662f\u5426\u9002\u5408\u7528\u4e8e\u9ad8\u5408\u89c4\u8981\u6c42\u7684\u533b\u7597\u5668\u68b0\u7814\u53d1\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Jira\u539f\u751f\u8bbe\u8ba1\u504f\u5411\u654f\u6377\u5f00\u53d1\uff0c\u5728\u533b\u7597\u5668\u68b0\u7684\u9ad8\u5408\u89c4\u9700\u6c42\uff08\u5982\u7aef\u5230\u7aef\u8ffd\u6eaf\u3001\u57fa\u7ebf\u7ba1\u7406\u3001\u6587\u6863\u63a7\u5236\uff09\u4e0a\u5b58\u5728\u77ed\u677f\u3002\u901a\u5e38\u9700\u8981\u642d\u914dJama Connect\u7b49\u4e13\u7528\u5de5\u5177\uff0c\u6216\u4f9d\u8d56\u5927\u91cf\u4ed8\u8d39\u63d2\u4ef6\u53ca\u590d\u6742\u7684\u4e8c\u6b21\u5f00\u53d1\u624d\u80fd\u6ee1\u8db3\u4e25\u683c\u7684\u5ba1\u8ba1\u8981\u6c42\u3002<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Helix_ALM%E5%92%8CJama_Connect%E5%9C%A8%E5%8C%BB%E7%96%97%E8%A1%8C%E4%B8%9A%E5%BA%94%E7%94%A8%E4%B8%AD%E6%9C%89%E4%BD%95%E6%A0%B8%E5%BF%83%E5%B7%AE%E5%BC%82%EF%BC%9F\"><\/span>Helix ALM\u548cJama Connect\u5728\u533b\u7597\u884c\u4e1a\u5e94\u7528\u4e2d\u6709\u4f55\u6838\u5fc3\u5dee\u5f02\uff1f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u4e24\u8005\u5747\u4e13\u6ce8\u4e8e\u9ad8\u5408\u89c4\u884c\u4e1a\u3002Helix ALM\u5728\u9700\u6c42\u3001\u6d4b\u8bd5\u4e0e\u4ee3\u7801\u7684\u5f3a\u5173\u8054\u53ca\u5e95\u5c42\u7248\u672c\u63a7\u5236\u4e0a\u6781\u4e3a\u4e25\u8c28\uff0c\u66f4\u504f\u5411\u4f20\u7edf\u7011\u5e03\u4e0eV\u6a21\u578b\u5f00\u53d1\uff1bJama Connect\u5219\u5728\u9700\u6c42\u7ed3\u6784\u5316\u534f\u4f5c\u3001\u98ce\u9669\u5371\u5bb3\u5206\u6790\uff08FMEA\uff09\u53ca\u884c\u4e1a\u6a21\u677f\uff08\u5982IEC 62304\uff09\u4e0a\u4f53\u9a8c\u66f4\u4f18\uff0c\u66f4\u9002\u5e94\u73b0\u4ee3\u590d\u6742\u7cfb\u7edf\u7684\u8fed\u4ee3\u534f\u540c\u3002<\/p>\n<h3><span class=\"ez-toc-section\" 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