{"id":63,"date":"2025-10-12T14:31:41","date_gmt":"2025-10-12T06:31:41","guid":{"rendered":"http:\/\/www.renewyou.cn\/?p=63"},"modified":"2025-10-12T14:56:01","modified_gmt":"2025-10-12T06:56:01","slug":"%e8%ae%be%e8%ae%a1%e9%aa%8c%e8%af%81%e4%b8%8e%e8%ae%be%e8%ae%a1%e7%a1%ae%e8%ae%a4%e5%9c%a8%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e5%bc%80%e5%8f%91%e4%b8%ad%e7%9a%84%e5%8c%ba%e5%88%ab","status":"publish","type":"post","link":"https:\/\/www.renewyou.cn\/?p=63","title":{"rendered":"\u8bbe\u8ba1\u9a8c\u8bc1\u4e0e\u8bbe\u8ba1\u786e\u8ba4\u5728\u533b\u7597\u5668\u68b0\u5f00\u53d1\u4e2d\u7684\u533a\u522b"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">\u8bbe\u8ba1\u9a8c\u8bc1\u4e0e\u8bbe\u8ba1\u786e\u8ba4\u5728\u533b\u7597\u5668\u68b0\u5f00\u53d1\u4e2d\u7684\u533a\u522b<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Design Validation vs Design Verification for Med Device Development<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5982\u679c\u60a8\u4ece\u4e8b\u4ea7\u54c1\u5f00\u53d1\u2014\u2014\u5c24\u5176\u662f\u533b\u7597\u5668\u68b0\u2014\u2014\u90a3\u4e48\u60a8\u4e00\u5b9a\u542c\u8bf4\u8fc7\u8bbe\u8ba1\u9a8c\u8bc1Design Verification\u548c\u8bbe\u8ba1\u786e\u8ba4Design Validation\uff08\u4e5f\u79f0\u4e3a V&amp;V\uff09\u8fd9\u4e24\u4e2a\u672f\u8bed\u3002\u672c\u6587\u5c06\u89e3\u91ca\u8fd9\u4e24\u9879\u6d3b\u52a8\u7684\u542b\u4e49\u3001\u5b83\u4eec\u4e4b\u95f4\u7684\u533a\u522b\uff0c\u5e76\u5206\u4eab\u4e00\u4e9b\u63d0\u5347\u5de5\u4f5c\u6210\u6548\u7684\u5efa\u8bae\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u6ce8\u610f\uff1a<\/strong>\u4e3a\u9a8c\u8bc1\u548c\u786e\u8ba4\u672c\u6587\u5185\u5bb9\uff0c\u6211\u4eec\u8054\u7cfb\u4e86\u5218\u8001\u5e08\uff0c\u5979\u662f\u4e00\u4f4d\u533b\u7597\u5668\u68b0\u987e\u95ee\uff0c\u5728\u533b\u7597\u5668\u68b0\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff08V&amp;V\uff09\u3001\u533b\u7597\u5668\u68b0\u8f6f\u4ef6\u3001\u4ea7\u54c1\u4e0e\u8f6f\u4ef6\u8d28\u91cf\u4ee5\u53ca\u7f8e\u56fd\u548c\u56fd\u9645\u5668\u68b0\u76d1\u7ba1\u7533\u62a5\u65b9\u9762\u62e5\u6709\u8d85\u8fc7 30 \u5e74\u7684\u7ecf\u9a8c\u3002\u60a8\u5c06\u5728\u6587\u4e2d\u591a\u5904\u770b\u5230\u5979\u7684\u89c1\u89e3\u548c\u793a\u4f8b\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u76ee\u5f55Table of Contents<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u6709\u4ec0\u4e48\u533a\u522b\uff1f<\/li>\n\n\n\n<li>\u4ec0\u4e48\u662f\u8bbe\u8ba1\u786e\u8ba4\uff08Design Validation\uff09\uff1f<\/li>\n\n\n\n<li>\u4ec0\u4e48\u662f\u9488\u5bf9NMPA\u7684\u8bbe\u8ba1\u9a8c\u8bc1\uff1f<\/li>\n\n\n\n<li>\u9a8c\u8bc1\u4e0e\u786e\u8ba4 \u6458\u8981<\/li>\n\n\n\n<li>\u8bbe\u8ba1\u786e\u8ba4\u6d41\u7a0b\u57fa\u7840<\/li>\n\n\n\n<li>\u8bbe\u8ba1\u9a8c\u8bc1\u6d41\u7a0b\u57fa\u7840<\/li>\n<\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u6709\u4ec0\u4e48\u533a\u522b\uff1fWhat&#8217;s the Difference Between Validation vs Verification?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u9a8c\u8bc1Verification\u548c\u786e\u8ba4Validation\u4e4b\u95f4\u6709\u4ec0\u4e48\u533a\u522b\uff1f\u7b80\u800c\u8a00\u4e4b\uff0c<strong>\u786e\u8ba4<\/strong><strong>Validation<\/strong>\u7528\u4e8e\u786e\u5b9a\u60a8\u662f\u5426\u5728\u6784\u5efa\u6b63\u786e\u7684\u4ea7\u54c1\u3002\u8be5\u5668\u68b0\u662f\u5426\u6309\u6700\u7ec8\u7528\u6237\u7684\u9884\u671f\u5de5\u4f5c\uff1f<strong>\u9a8c\u8bc1<\/strong>Verification\u7528\u4e8e\u786e\u5b9a\u60a8\u662f\u5426\u4ee5\u6b63\u786e\u7684\u65b9\u5f0f\u6784\u5efa\u4ea7\u54c1\u3002\u8bbe\u8ba1\u8f93\u51fa\u662f\u5426\u4e0e\u8bbe\u8ba1\u8f93\u5165\u76f8\u7b26\uff1f<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u5c31\u662f\u4e0b\u9762\u56fe\u8868\u6e05\u695a\u63cf\u7ed8\u7684\u7b80\u5355\u533a\u522b\u3002<br>&nbsp;<a href=\"https:\/\/www.perforce.com\/sites\/default\/files\/inline-images\/design-validation-chart.png\"><\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><br>\u8ba9\u6211\u4eec\u66f4\u4ed4\u7ec6\u5730\u770b\u4e00\u4e0b\u6bcf\u4e2a\u9636\u6bb5\uff0c\u4ece\u786e\u8ba4Validation\u5f00\u59cb\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4ec0\u4e48\u662f\u8bbe\u8ba1\u786e\u8ba4\uff08Design Validation\uff09\uff1fWhat Is Design Validation Exactly?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bbe\u8ba1\u786e\u8ba4\u662f\u4e00\u79cd\u901a\u8fc7\u6d4b\u8bd5\u7684\u8fc7\u7a0b\uff0c\u7528\u4ee5\u8bc1\u660e\uff08\u201c\u786e\u8ba4\u201d\uff09\u60a8\u6240\u5236\u9020\u7684\u5668\u68b0\u80fd\u591f\u6309\u6700\u7ec8\u7528\u6237\u7684\u9884\u671f\u53d1\u6325\u4f5c\u7528\u3002\u201cestablishing by objective evidence that device specifications conform with user needs and intended use(s).\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u6765\u81eaFDA\uff0821 CFR 820.3\uff09\u7684\u5b98\u65b9\u8868\u8ff0\u79f0\uff0c\u8bbe\u8ba1\u786e\u8ba4\u662f\u201c\u901a\u8fc7\u5ba2\u89c2\u8bc1\u636e\u8bc1\u660e\u5668\u68b0\u89c4\u683c\u7b26\u5408\u7528\u6237\u9700\u6c42user needs\u548c\u9884\u671f\u7528\u9014intended use(s)\u3002\u201d<br><br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u8bbe\u8ba1\u786e\u8ba4\u793a\u4f8bDesign Validation Example<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><img loading=\"lazy\" decoding=\"async\" width=\"196\" height=\"110\" src=\"\" alt=\"\u4fbf\u643a\u5f0f\u673a\u68b0\u547c\u5438\u673a\"><a><\/a><\/td><td><img loading=\"lazy\" decoding=\"async\" width=\"163\" height=\"122\" src=\"\" alt=\"\u666e\u535a\u4fbf\u643a\u5f0f\u6025\u6551\u8f6c\u8fd0\u547c\u5438\u673aBoaray1000D ...\"><\/td><td><img loading=\"lazy\" decoding=\"async\" width=\"178\" height=\"127\" src=\"\" alt=\"\u7f8e\u56fd\u5353\u5c14ZOLL\u4fbf\u643a\u5f0f\u547c\u5438\u673aEMV+ - \u6db5\u98de\u533b\u7597 ...\"><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u5047\u8bbe\u6211\u4eec\u6b63\u5728\u8bbe\u8ba1\u4e00\u53f0\u5728\u8fd0\u8f93\u75c5\u4eba\u65f6\u7ef4\u6301\u5176\u547c\u5438\u7684\u547c\u5438\u673a\uff0c\u800c\u7528\u6237\u5e0c\u671b\u786e\u4fdd\u8be5\u547c\u5438\u673a\u5728\u75c5\u4eba\u8f6c\u8fd0\u8fc7\u7a0b\u4e2d\u80fd\u6b63\u5e38\u5de5\u5de5\u4f5c\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9996\u5148\uff0c\u6211\u4eec\u5fc5\u987b\u5b9a\u4e49\u7528\u6237\u9700\u6c42user needs\u3002\u7528\u6237\u5e0c\u671b\u5728\u60a3\u8005\u4ecd\u8fde\u63a5\u547c\u5438\u673a\u65f6\u80fd\u591f\u79fb\u52a8\u4ed6\u4eec\u3002\u4f46\u4ed6\u4eec\u5b9e\u9645\u4e0a\u60f3\u8981\u505a\u4ec0\u4e48\uff1f\u201c\u8f6c\u8fd0\u8fc7\u7a0b\u201d\u53ef\u80fd\u5305\u62ec\u5728\u533b\u9662\u5185\u79fb\u52a8\u60a3\u8005\uff0c\u6216\u53ef\u80fd\u5305\u62ec\u901a\u8fc7\u6551\u62a4\u8f66\u6216\u822a\u7a7a\u8fd0\u8f93\u3002\u4e3e\u4f8b\u6765\u8bf4\uff0c\u4e00\u4e2a\u7528\u6237\u9700\u6c42\u53ef\u80fd\u5982\u4e0b\u6240\u793a\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u7528\u6237\u9700\u6c42User Need<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>UsNe-0001<\/strong><\/td><td><strong>\u8be5\u547c\u5438\u673a\u9002\u7528\u4e8e\u642c\u8fd0\uff08\u8f6c\u8fd0\uff09\u75c5\u4eba\u65f6\u4f7f\u7528\u3002<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><br>\u8fd9\u4e2a\u7528\u6237\u9700\u6c42user need\u5c06\u88ab\u5206\u89e3\u4e3a\u4ea7\u54c1\u9700\u6c42product requirements\u548c\u8bbe\u8ba1\u89c4\u8303design specifications\uff0c\u4ee5\u4fbf\u8bbe\u8ba1\u548c\u5236\u9020\u4ea7\u54c1\u3002\uff08\u6211\u4eec\u7a0d\u540e\u5c06\u5728\u8bbe\u8ba1\u9a8c\u8bc1\u4e00\u8282\u4e2d\u67e5\u770b\u8fd9\u4e9b\u5185\u5bb9\u3002\uff09<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u6b64\u4e4b\u524d\uff0c\u8ba9\u6211\u4eec\u5ba1\u67e5\u7528\u6237\u9700\u6c42user need\u5e76\u67e5\u770b\u53ef\u80fd\u9700\u8981\u54ea\u4e9b\u8bbe\u8ba1\u786e\u8ba4\uff08validation\uff09\u6d4b\u8bd5\u7528\u4f8b\u3002\u5bf9\u6211\u4eec\u7528\u6237\u9700\u6c42\u7684\u786e\u8ba4\u6d4b\u8bd5\u53ef\u80fd\u5982\u4e0b\u6240\u793a\u3002<br><br><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"2\"><strong>\u7528\u6237\u9700\u6c42<\/strong><\/td><td colspan=\"2\"><strong>\u786e\u8ba4\uff08Validation<\/strong><strong>\uff09\u6d4b\u8bd5<\/strong><\/td><\/tr><tr><td rowspan=\"3\"><strong>UsNe-0001<\/strong><\/td><td rowspan=\"3\">\u8be5\u547c\u5438\u673a\u9002\u7528\u4e8e\u9662\u5185\u8f6c\u8fd0\u671f\u95f4\u7684\u60a3\u8005\u4f7f\u7528\u3002<\/td><td>TCase-0001<\/td><td>\u786e\u8ba4\u6d4b\u8bd5\u7528\u4f8b\uff1a\u6d4b\u8bd5\u547c\u5438\u673a\u80fd\u5426\u88ab\u533b\u9662\u8fd0\u8f93\u4eba\u5458\u4e2d\u768415\u540d\u6210\u5458\u8f7b\u677e\u63a8\u884c\u3002<\/td><\/tr><tr><td>TCase-0002<\/td><td>\u786e\u8ba4\u6d4b\u8bd5\u7528\u4f8b\uff1a\u6d4b\u8bd5\u547c\u5438\u673a\u5728\u88ab\u63a8\u884c\u8fc7\u8d70\u5eca\u3001\u8de8\u8d8a\u95e8\u69db\u548c\u7535\u68af\u95e8\u69db\u65f6\u662f\u5426\u5728\u5176\u8bbe\u8ba1\u6027\u80fd\u89c4\u683c\u8303\u56f4\u5185\u8fd0\u884c\u3002<\/td><\/tr><tr><td>TCase-0003<\/td><td>\u786e\u8ba4\u6d4b\u8bd5\u7528\u4f8b\uff1a\u6d4b\u8bd5\u547c\u5438\u673a\u5728\u4ea4\u6d41\u7535\u548c\u7535\u6c60\u4f9b\u7535\u4e4b\u95f4\u5207\u6362\u65f6\u662f\u5426\u5728\u5176\u8bbe\u8ba1\u6027\u80fd\u89c4\u683c\u8303\u56f4\u5185\u8fd0\u884c\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><br>\u786e\u8ba4\u6d4b\u8bd5\u5e94\u5305\u62ec\u6d4b\u8bd5\u7528\u4f8b\u3001\u6d4b\u8bd5\u65b9\u6848\uff0c\u751a\u81f3\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u65e8\u5728\u8bc1\u660e\u6309\u5df2\u5efa\u9020\u7684\u4ea7\u54c1\u5728\u7528\u6237\u9884\u671f\u4f7f\u7528\u7684\u6761\u4ef6\u4e0b\u6309\u7528\u6237\u671f\u671b\u8fd0\u884c\u3002\u7531\u4e8e\u8fd9\u4e9b\u6d4b\u8bd5\u5e94\u5728\u751f\u4ea7\u6216\u4e0e\u751f\u4ea7\u7b49\u6548\u7684\u5355\u5143\u4e0a\u8fdb\u884c\uff0c\u8bbe\u8ba1\u786e\u8ba4\u6d4b\u8bd5\u901a\u5e38\u662f\u6700\u540e\u8fdb\u884c\u7684\u6d4b\u8bd5\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u57fa\u672c\u4e0a\uff0c\u5728\u8bbe\u8ba1\u786e\u8ba4\uff08validation\uff09\u4e2d\uff0c\u6211\u4eec\u9700\u8981\u8bc1\u660e\u4ea7\u54c1\u6ee1\u8db3\u7528\u6237\u7684\u9700\u6c42\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u987a\u4fbf\u63d0\u4e00\u4e0b\uff0c\u4e0a\u8868\u8fd8\u663e\u793a\u4e86<em>\u53ef\u8ffd\u6eaf\u6027<\/em><em>traceability<\/em>\u4ece\u7528\u6237\u9700\u6c42user needs\u5230\u6d4b\u8bd5\u7528\u4f8b&nbsp;test cases.\u7684\u5bf9\u5e94\u5173\u7cfb\u3002\u8be5\u53ef\u8ffd\u6eaf\u77e9\u9635trace matrix\u63d0\u4f9b\u4e86\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08NMPA\uff09\u6240\u8981\u6c42\u7684\u90e8\u5206\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff08V&amp;V\uff09\u8bc1\u636e\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4ec0\u4e48\u662fNMPA\u7684\u8bbe\u8ba1\u9a8c\u8bc1\uff1fWhat Is Design Verification for NMPA?&nbsp;<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bbe\u8ba1\u9a8c\u8bc1\u662f\u4f60\u6d4b\u8bd5\uff08\u201c\u9a8c\u8bc1\u201d\uff09\u8bbe\u8ba1\u8f93\u51fa\u662f\u5426\u4e0e\u8bbe\u8ba1\u8f93\u5165\u76f8\u5339\u914d\u7684\u73af\u8282\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u518d\u6b21\uff0c\u6839\u636eFDA\u7684\u5b9a\u4e49\uff0c\u8bbe\u8ba1\u9a8c\u8bc1\u662f\u201c\u901a\u8fc7\u68c0\u67e5\u5e76\u63d0\u4f9b\u5ba2\u89c2\u8bc1\u636e\u4ee5\u786e\u8ba4\u5df2\u6ee1\u8db3\u89c4\u5b9a\u8981\u6c42\u201d\u3002\u201cconfirmation by examination and provision of objective evidence that specified requirements have been fulfilled.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bf7\u8bb0\u4f4f\uff0c\u5c3d\u7ba1\u8fd9\u5c06\u6d89\u53ca\u6d4b\u8bd5\uff0c\u4f46\u8fd8\u6709\u5176\u4ed6\u53ef\u63a5\u53d7\u7684\u9a8c\u8bc1\u6d3b\u52a8\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b83\u4eec\u53ef\u4ee5\u5305\u62ec\u6d4b\u8bd5\u3001\u68c0\u67e5\u548c\u5206\u6790\u7b49\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u8bbe\u8ba1\u9a8c\u8bc1\u793a\u4f8bDesign Verification Example<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ba9\u6211\u4eec\u56de\u5230\u547c\u5438\u673a\u7684\u4f8b\u5b50\u3002\u6211\u4eec\u5df2\u7ecf\u786e\u5b9a\u4e86\u7528\u6237\u9700\u6c42user needs\uff1b\u73b0\u5728\u8ba9\u6211\u4eec\u786e\u5b9a\u8bbe\u5907\u5fc5\u987b\u505a\u4ec0\u4e48\u4ee5\u53ca\u5fc5\u987b\u5982\u4f55\u53bb\u505a\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3a\u6b64\uff0c\u6211\u4eec\u9700\u8981\u5b9a\u4e49\u5177\u4f53\u7684\u4ea7\u54c1\u8981\u6c42\u3002\u4f8b\u5982\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u60a3\u8005\u7684\u6700\u5927\u8d1f\u8f7d\u662f\u591a\u5c11\uff1f\uff08\u547c\u5438\u673a\u9700\u8981\u8fd0\u9001\u591a\u5c11\u7a7a\u6c14\uff1f\uff09<\/li>\n\n\n\n<li>\u7535\u6c60\u9700\u8981\u7eed\u822a\u591a\u4e45\uff1f\uff08\u8f6c\u8fd0[\u642c\u8fd0]\u9700\u8981\u591a\u957f\u65f6\u95f4\uff1f\uff09<\/li>\n\n\n\n<li>\u5728\u8fd0\u8f93\u8fc7\u7a0b\u4e2d\u4f1a\u9047\u5230\u54ea\u4e9b\u60c5\u51b5\uff1f\uff08\u95e8\u628a\u624b\u5361\u4f4f\uff1f\u7535\u68af\uff1f\uff09<\/li>\n\n\n\n<li>\u662f\u5426\u9700\u8981\u6ee1\u8db3\u4efb\u4f55\u76d1\u7ba1\u6cd5\u89c4\u548c\u6807\u51c6\uff1f\uff08\u5b89\u5168\u6807\u51c6\uff1f\uff09<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u201c<\/em><em>\u6e05\u6670\u3001\u5b8c\u6574\u3001\u65e0\u6b67\u4e49\u3001\u53ef\u6d4b\u8bd5\u7684\u9700\u6c42\u662f\u6210\u529f\u5f00\u53d1\u9879\u76ee\u7684\u5173\u952e\u7ec4\u6210\u90e8\u5206\u3002\u4e0d\u5145\u5206\u7684\u9700\u6c42\u4f1a\u5bfc\u81f4\u65f6\u95f4\u6d6a\u8d39\u3001\u8bbe\u8ba1\u9519\u8bef\u3001\u5927\u91cf\u8fd4\u5de5\u4ee5\u53ca\u8106\u5f31\u6216\u6613\u51fa\u9519\u7684\u4ea7\u54c1\u3002\u201d \u2013<\/em><em>\u5218\u8001\u5e08\uff0cV&amp;V <\/em><em>\u987e\u95ee<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8fd9\u662f\u5b9a\u4e49\u5668\u68b0\u7279\u6027\u4e2d\u7684\u201c\u4ec0\u4e48What\u201d\u90e8\u5206\u3002<em>\u5668\u68b0\u7a76\u7adf\u9700\u8981\u505a\u4ec0\u4e48\uff1f\uff08<\/em><em>What exactly will the device need to do?<\/em><em>\uff09<\/em>\u6211\u4eec\u7684\u7528\u6237\u9700\u6c42&nbsp;user need\u7684\u4ea7\u54c1\u8981\u6c42Product requirements\uff08\u901a\u5e38\u5305\u542b\u5728<a href=\"https:\/\/www.perforce.com\/blog\/alm\/how-write-product-requirements-document-prd\">\u4ea7\u54c1\u9700\u6c42\u6587\u6863<\/a>\u4e2d\uff09\u53ef\u80fd\u5982\u4e0b\u6240\u793a\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u4ea7\u54c1\u9700\u6c42Product Requirements<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>PrRq-0001<\/strong><\/td><td>\u547c\u5438\u673a\u7684\u6700\u5927\u8bbe\u5b9a\u4e3a\u5bb9\u79ef\u63a7\u5236\u547c\u5438\u6bcf\u6b212\u5347\uff0c\u9891\u7387\u4e3a\u6bcf\u5206\u949f20\u6b21\u3002<\/td><\/tr><tr><td><strong>PrRq-0002<\/strong><\/td><td>\u547c\u5438\u673a\u5728\u6700\u9ad8\u8bbe\u7f6e\u4e0b\u5e94\u80fd\u4ee5\u7535\u6c60\u4f9b\u7535\u8fd0\u884c\u81f3\u5c1190\u5206\u949f\u3002<\/td><\/tr><tr><td><strong>PrRq-0003<\/strong><\/td><td>\u547c\u5438\u673a\u5e94\u80fd\u591f\u5b89\u88c5\u5728\u5e26\u8f6e\u652f\u67b6\u4e0a\u3002<\/td><\/tr><tr><td><strong>PrRq-0004<\/strong><\/td><td>\u547c\u5438\u673a\u53ca\u5176\u652f\u67b6\u5e94\u80fd\u901a\u8fc7\u5178\u578b\u533b\u9662\u95e8\u69db\u548c\u7535\u68af\u95e8\u69db\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><br>\u6700\u540e\uff0c\u6211\u4eec\u9700\u8981\u8bbe\u8ba1\u89c4\u8303design specification\u3002\u201c\u6211\u4eec\u5df2\u7ecf\u5b9a\u4e49\u4e86<em>\u8981\u505a\u4ec0\u4e48<\/em>\uff0c\u73b0\u5728\u9700\u8981\u5b9a\u4e49\u5982\u4f55\u53bb\u505a\uff0c\u201d&#8211;\u5218\u8001\u5e08\u8bf4\u3002\u8fd9\u53ef\u4ee5\u901a\u8fc7\u591a\u79cd\u65b9\u5f0f\u5b9e\u73b0\uff0c\u5305\u62ec\u4e66\u9762\u89c4\u8303\u3001\u7535\u6c14\u6216\u673a\u68b0\u56fe\u7eb8\u3001\u7ec4\u4ef6\u8d2d\u89c4\u683c\u6216\u5176\u4ed6\u65b9\u6cd5\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f8b\u5982\uff0c\u8bbe\u8ba1\u89c4\u8303\u548c\u56fe\u7eb8\u53ef\u80fd\u663e\u793a\u4ee5\u4e0b\u5185\u5bb9\u3002<br><br><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u8bbe\u8ba1\u89c4\u8303Product Requirements<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td>DSpec-0001<\/td><td>\u4e00\u53f0\u53ef\u4ea7\u751f\u9ad8\u8fbe40\u5347\/\u5206\u949f\u6c14\u6d41\u7684\u6da1\u8f6e\u3002<\/td><\/tr><tr><td>DSpec-0002<\/td><td>\u989d\u5b9a\u81f3\u5c11100\u5b89\u65f6\u7684\u9502\u79bb\u5b50\u7535\u6c60\u7ec4\u3002<\/td><\/tr><tr><td>DSpec-0003<\/td><td>\u6eda\u52a8\u652f\u67b6\u7684\u5b89\u88c5\u4ef6\u4f7f\u7528\u989d\u5b9a22\u78c5\u7684\u94a2\u8d28\u6760\u6746\u5f0f\u5939\u5177\u3002<\/td><\/tr><tr><td>DSpec-0004<\/td><td>\u652f\u67b6\u5e95\u5ea7\u5bbd22\u82f1\u5bf8\uff0c\u914d\u67095\u4e2a\u8f6e\u5b50\u3002<\/td><\/tr><tr><td>DSpec-0005<\/td><td>\u652f\u67b6\u8f6e\u5b50\u76f4\u5f84\u4e3a4\u82f1\u5bf8\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><br>\u8bbe\u8ba1\u9a8c\u8bc1Design verification\u63d0\u4f9b\u8bc1\u636e\uff08\u6d4b\u8bd5\u7ed3\u679ctest results\uff09\uff0c\u8bc1\u660e\u8bbe\u8ba1\u8f93\u51fa\uff08\u5b9e\u9645\u4ea7\u54c1\uff09\u6ee1\u8db3\u8bbe\u8ba1\u8f93\u5165\uff08\u4ea7\u54c1\u9700\u6c42product requirements\u548c\u8bbe\u8ba1\u89c4\u8303design specifications\uff09\u3002\u6839\u636e\u88ab\u9a8c\u8bc1\u7684\u9879\u76ee\uff0c\u53ef\u80fd\u4f1a\u6267\u884c\u6d4b\u8bd5\u7528\u4f8b\u6216\u6d4b\u8bd5\u65b9\u6848\uff0c\u6216\u8fdb\u884c\u68c0\u6d4b\u6216\u5206\u6790\u4ee5\u63d0\u4f9b\u6240\u9700\u7684\u8bc1\u636e\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0b\u8868\u793a\u4f8b\u8bf4\u660e\u4e86\u53ef\u80fd\u7684\u60c5\u51b5\u3002\u5b83\u4eec\u8fd8\u5c55\u793a\u4e86NMPA\u6240\u671f\u671b\u7684\u53ef\u8ffd\u6eaf\u6027\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"2\">\u4ea7\u54c1\u9700\u6c42<\/td><td colspan=\"2\">\u9a8c\u8bc1\u6d4b\u8bd5<\/td><\/tr><tr><td><strong>PrRq-0001<\/strong><strong><\/strong><\/td><td>\u547c\u5438\u673a\u7684\u6700\u5927\u8bbe\u5b9a\u4e3a\u5bb9\u79ef\u63a7\u5236\u547c\u5438\u6bcf\u6b212\u5347\uff0c\u9891\u7387\u4e3a\u6bcf\u5206\u949f20\u6b21\u3002<\/td><td>TCase-0004<\/td><td>\u6d4b\u8bd5\u7528\u4f8b\uff1a\u9a8c\u8bc1\u547c\u5438\u7684\u6700\u5927\u8bbe\u7f6e\u6216\u547c\u5438\u8bbe\u7f6e\u7ec4\u5408\u3002<\/td><\/tr><tr><td rowspan=\"2\"><strong>PrRq-0002<\/strong><strong><\/strong><\/td><td rowspan=\"2\">\u547c\u5438\u673a\u5728\u6700\u9ad8\u8bbe\u7f6e\u4e0b\u5e94\u80fd\u4ee5\u7535\u6c60\u4f9b\u7535\u8fd0\u884c\u81f3\u5c1190\u5206\u949f\u3002<\/td><td>TCase-0005<\/td><td>\u6d4b\u8bd5\u65b9\u6848\uff1a\u5728\u5168\u65b0\u5145\u6ee1\u7535\u7684\u7535\u6c60\u4e0a\u4ee5\u6700\u5927\u8bbe\u7f6e\u9a8c\u8bc1\u8fd0\u884c\u65f6\u95f4\u3002<\/td><\/tr><tr><td>TCase-0006<\/td><td>\u6d4b\u8bd5\u65b9\u6848\uff1a\u4f7f\u7528\u5df2\u7ecf\u538650\u6b21\u5145\u7535\u5faa\u73af\u7684\u7535\u6c60\u9a8c\u8bc1\u5728\u6700\u5927\u8bbe\u7f6e\u4e0b\u7684\u8fd0\u884c\u65f6\u95f4\u3002<\/td><\/tr><tr><td><strong>PrRq-0003<\/strong><strong><\/strong><\/td><td>\u547c\u5438\u673a\u5e94\u80fd\u591f\u5b89\u88c5\u5728\u5e26\u8f6e\u652f\u67b6\u4e0a\u3002<\/td><td>TCase-0007<\/td><td>\u6f14\u793a\u6d4b\u8bd5\uff1a\u6f14\u793a\u547c\u5438\u673a\u53ef\u4ece\u5e26\u8f6e\u652f\u6491\u67b6\u4e0a\u8fde\u63a5\u548c\u62c6\u5378\u3002<\/td><\/tr><tr><td><strong>PrRq-0004<\/strong><strong><\/strong><\/td><td>\u547c\u5438\u673a\u53ca\u5176\u652f\u67b6\u5e94\u80fd\u901a\u8fc7\u5178\u578b\u533b\u9662\u95e8\u69db\u548c\u7535\u68af\u95e8\u69db\u3002<\/td><td>TCase-0008<\/td><td>\u5916\u90e8\u6d4b\u8bd5\uff1a\u7531\u6d4b\u8bd5\u670d\u52a1\u6267\u884c\u7684\u6d4b\u8bd5\uff0c\u7528\u4ee5\u9a8c\u8bc1\u547c\u5438\u673a\u548c\u652f\u67b6\u80fd\u6309 IEC 60601-1 \u533b\u7597\u7535\u6c14\u6807\u51c6\u5728\u4e0d\u7ffb\u5012\u7684\u60c5\u51b5\u4e0b\u8d8a\u8fc7\u95e8\u69db\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u5bf9\u4ea7\u54c1\u9700\u6c42product requirements\u7684\u9a8c\u8bc1\uff08\u5982\u4e0a\uff09\u8868\u660e\u4ea7\u54c1\u5b8c\u6210\u4e86\u6211\u4eec\u8981\u6c42\u4ea7\u54c1\u6240\u5177\u5907\u7684\u4e8b\uff08\u6027\u80fd\u3001\u529f\u80fd\u7b49\uff09\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bbe\u8ba1\u89c4\u683cdesign specifications\u7684\u786e\u8ba4\uff08\u4e0b\u9762\u5c06\u5c55\u793a\uff09\u8868\u660e\u4ea7\u54c1\u6309\u7167\u6211\u4eec\u6240\u8bf4\u7684\u65b9\u5f0f\u8fd0\u884c\uff08\u5de5\u4f5c\uff09\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td colspan=\"2\"><strong>\u8bbe\u8ba1\u89c4\u8303<\/strong><strong><\/strong><\/td><td colspan=\"2\"><strong>\u9a8c\u8bc1\u6d4b\u8bd5<\/strong><strong><\/strong><\/td><\/tr><tr><td><strong>DSpec-0001<\/strong><strong><\/strong><\/td><td>\u80fd\u591f\u4ea7\u751f\u6bcf\u5206\u949f40\u5347\u7a7a\u6c14\u7684\u6da1\u8f6e\u3002<\/td><td>TCase-0009<\/td><td>\u6d4b\u8bd5\u65b9\u6848\uff1a\u9a8c\u8bc1\u6da1\u8f6e\u5728\u4ea4\u6d41\u7535\u6216\u7535\u6c60\u7535\u6e90\u4e0b\u4ee5 40 lpm \u4ea7\u751f\u7a7a\u6c14\u3002<\/td><\/tr><tr><td rowspan=\"2\"><strong>DSpec-0002<\/strong><strong><\/strong><\/td><td rowspan=\"2\">\u4e00\u4e2a\u989d\u5b9a\u5bb9\u91cf\u4e3a100\u5b89\u65f6\u7684\u9502\u79bb\u5b50\u7535\u6c60\u7ec4\u3002<\/td><td>TCase-0010<\/td><td>\u68c0\u9a8c\u6d4b\u8bd5\uff1a\u9a8c\u8bc1\u7535\u6c60\u91c7\u8d2d\u89c4\u683c\u663e\u793a\u7c7b\u578b\u4e3a\u9502\u79bb\u5b50\u3002<\/td><\/tr><tr><td>TCase-0011<\/td><td>\u5206\u6790\u6d4b\u8bd5\uff1a\u6536\u96c6\u6d4b\u8bd5\u6570\u636e\u5e76\u8fdb\u884c\u6570\u636e\u5206\u6790\uff0c\u4ee5\u8bc1\u660e\u7535\u6c60\u5728\u5176\u4f7f\u7528\u5bff\u547d\u671f\u95f4\u7684\u6027\u80fd\u5c06\u8fbe\u5230\u6216\u8d85\u8fc7100\u6bcf\u5b89\u65f6\uff08Amp\uff09\u3002<\/td><\/tr><tr><td><strong>DSpec-0003<\/strong><strong><\/strong><\/td><td>\u6eda\u52a8\u652f\u67b6\u7684\u5b89\u88c5\u4ef6\u4f7f\u7528\u989d\u5b9a22\u78c5\u7684\u94a2\u8d28\u6760\u6746\u5f0f\u5939\u5177\u3002<\/td><td>TCase-0012<\/td><td>\u68c0\u9a8c\u6d4b\u8bd5\uff1a\u9a8c\u8bc1\u96f6\u4ef6\u89c4\u683c\u4e3a\u989d\u5b9a22\u78c5\u6216\u66f4\u9ad8\u7684\u94a2\u5236\u6760\u6746\u5f0f\u5939\u5177\u3002<\/td><\/tr><tr><td><strong>DSpec-0004<\/strong><strong><\/strong><\/td><td>\u652f\u67b6\u5e95\u5ea7\u5bbd22\u82f1\u5bf8\uff0c\u914d\u67095\u4e2a\u8f6e\u5b50\u3002<\/td><td rowspan=\"2\">TCase-0013<\/td><td rowspan=\"2\">\u6d4b\u8bd5\u7528\u4f8b\uff1a\u6d4b\u91cf\u57fa\u5ea7\u76f4\u5f84\uff1b\u8ba1\u6570\u8f66\u8f6e\uff1b\u6d4b\u91cf\u8f66\u8f6e\u76f4\u5f84<\/td><\/tr><tr><td><strong>DSpec-0005<\/strong><strong><\/strong><\/td><td>\u652f\u67b6\u8f6e\u5b50\u76f4\u5f84\u4e3a4\u82f1\u5bf8\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u672c\u8d28\u4e0a\uff0c\u5728\u8bbe\u8ba1\u9a8c\u8bc1\u4e2ddesign verification\uff0c\u6211\u4eec\u9700\u8981\u8bc1\u660e\u6211\u4eec\u5236\u9020\u7684\u4ea7\u54c1\u5c31\u662f\u6211\u4eec\u6240\u58f0\u660e\u8981\u5236\u9020\u7684\u4ea7\u54c1\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5f53\u5728\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff08V&amp;V\uff09\u62a5\u544a\u4e2d\u6c47\u603b\u65f6\uff0c\u9a8c\u8bc1\u548c\u786e\u8ba4\u6d4b\u8bd5\u7ed3\u679c\u7684\u7ec4\u5408\uff0c\u4ee5\u53ca\u53ef\u8ffd\u6eaf\u5230\u7528\u6237\u9700\u6c42user needs\u3001\u4ea7\u54c1\u8981\u6c42product requirements\u548c\u8bbe\u8ba1\u89c4\u8303design specifications\u7684\u94fe\u6761\uff0c\u6784\u6210\u4e86\u5411NMPA\u63d0\u4ea4\u533b\u7597\u5668\u68b0\u4ee5\u7533\u8bf7\u6279\u51c6\u65f6\u6240\u9700\u8bc1\u636e\u7684\u4e00\u90e8\u5206\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u6458\u8981Validation vs Verification Summary<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e0b\u9762\u662f\u4e00\u4e2a\u7b80\u77ed\u4e14\u7565\u4e3a\u7b80\u5316\u7684\u5173\u952e\u5dee\u5f02\u603b\u7ed3\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td><strong>\u8bbe\u8ba1\u9a8c\u8bc1Design Verification<\/strong><\/td><td><strong>\u8bbe\u8ba1\u786e\u8ba4Design Validation<\/strong><\/td><\/tr><tr><td>\u8bbe\u8ba1\u8f93\u51fa\u7b26\u5408\u9884\u671f\u3002<\/td><td>\u6700\u7ec8\u8bbe\u8ba1\u6ee1\u8db3\u7528\u6237\u9700\u6c42\u3002<\/td><\/tr><tr><td>\u7cfb\u7edf\u3001\u5b50\u7cfb\u7edf\u548c\u5355\u5143\u6d4b\u8bd5\u3002<\/td><td>\u7cfb\u7edf\u6d4b\u8bd5\u3002<\/td><\/tr><tr><td>\u5728\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u3002<\/td><td>\u5f00\u53d1\u5b8c\u6210\u540e\u3002<\/td><\/tr><tr><td>\u5728\u4efb\u4f55\u6761\u4ef6\u4e0b\u6d4b\u8bd5\u5355\u4e2a\u6a21\u5757\u6216\u5b8c\u6210\u7684\u7cfb\u7edf\u3002<\/td><td>\u6839\u636e\u7528\u6237\u9700\u6c42\u786e\u5b9a\u6d4b\u8bd5\u6761\u4ef6\u3002<\/td><\/tr><tr><td>\u5305\u62ec\u7cfb\u7edf\u68c0\u67e5\u3001\u5206\u6790\u548c\u6d4b\u8bd5\u3002<\/td><td>\u5305\u62ec\u5728\u5b9e\u9645\u4f7f\u7528\u6761\u4ef6\u4e0b\u5bf9\u7b49\u540c\u4e8e\u751f\u4ea7\u7684\u5668\u4ef6\u8fdb\u884c\u7684\u6d4b\u8bd5\u3002<\/td><\/tr><tr><td>\u5305\u62ec\u6240\u6267\u884c\u6d4b\u8bd5\u7684\u62a5\u544a\u3001\u6d4b\u8bd5\u7ed3\u679c\u548c\u53ef\u8ffd\u6eaf\u6027\u3002\u62a5\u544a\u7ecf\u8fc7\u5ba1\u67e5\u3001\u6279\u51c6\u5e76\u7b7e\u7f72\u3002<\/td><td>\u5305\u62ec\u6700\u7ec8\u62a5\u544a\uff0c\u542b\u6d4b\u8bd5\u7ed3\u679c\u548c\u53ef\u8ffd\u6eaf\u6027\uff0c\u51c6\u5907\u63a5\u53d7\u76d1\u7ba1\u5ba1\u67e5\u3002 \u62a5\u544a\u7ecf\u8fc7\u5ba1\u67e5\u3001\u6279\u51c6\u5e76\u7b7e\u7f72\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u8bbe\u8ba1\u786e\u8ba4\u7a0b\u7684\u57fa\u7840\u8981\u6c42Basics of Design Validation Process<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bbe\u8ba1\u786e\u8ba4\u8fc7\u7a0b\u5728\u5f88\u5927\u7a0b\u5ea6\u4e0a\u5c06\u7531\u5bf9\u5668\u68b0\u7684\u6d4b\u8bd5\u6784\u6210\u3002\u6839\u636e\u5177\u4f53\u60c5\u51b5\uff0c\u60a8\u53ef\u4ee5\u901a\u8fc7\u51e0\u79cd\u65b9\u5f0f\u8fdb\u884c\u6b64\u9879\u5de5\u4f5c\u3002\u6d3b\u52a8\u53ef\u4ee5\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e0e\u7528\u4e8e\u7c7b\u4f3c\u76ee\u7684\u7684\u7c7b\u4f3c\u8bbe\u5907\u8fdb\u884c\u6bd4\u8f83\u3002<\/li>\n\n\n\n<li>\u901a\u8fc7\u6570\u5b66\u5efa\u6a21\u6a21\u62df\u529f\u80fd\u3002<\/li>\n\n\n\n<li>\u6d4b\u8bd5\u6700\u7ec8\u8bbe\u8ba1\u4ee5\u8bc1\u660e\u7cfb\u7edf\u6309\u7167\u7528\u6237\u9700\u6c42\u5b9a\u4e49\u7684\u65b9\u5f0f\u8fd0\u884c\u3002<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u6d4b\u8bd5\u8ba1\u5212\u3001\u6d4b\u8bd5\u7528\u4f8b\u3001\u6d4b\u8bd5\u6267\u884c\u8bb0\u5f55\u548c\u6d4b\u8bd5\u7ed3\u679c\u5e94\u4f5c\u4e3a\u8bbe\u8ba1\u8bb0\u5f55\u7684\u4e00\u90e8\u5206\u8fdb\u884c\u8bb0\u5f55\u548c\u7ef4\u62a4\u3002\u786e\u8ba4\u5e76\u975e\u5355\u4e00\u6d3b\u52a8\u7684\u7ed3\u679c\uff0c\u800c\u662f\u6240\u6709\u786e\u8ba4\u6d3b\u52a8\u7ed3\u679c\u7684\u6c47\u603b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u8bbe\u8ba1\u9a8c\u8bc1\u6d41\u7a0b\u57fa\u7840\u8981\u6c42Basics of Design Verification Process<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u9a8c\u8bc1\u53ef\u4ee5\u7b80\u5316\u4e3a\u4e00\u4e2a\u7b80\u5355\u7684\u4e94\u6b65\u8fc7\u7a0b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u8bc6\u522b\u4e0e\u51c6\u5907Identifying and Preparing<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u786e\u5b9a\u8fdb\u884c\u9a8c\u8bc1\u7684\u6700\u4f73\u65b9\u6cd5\u3002\u5b9a\u4e49\u8981\u6d4b\u91cf\u7684\u5185\u5bb9\u4ee5\u53ca\u6d4b\u91cf\u65b9\u6cd5\u3002\u8fd8\u9700\u8981\u8003\u8651\u6210\u529f\u9a8c\u8bc1\u6240\u9700\u7684\u8d44\u6e90\u3001\u4eba\u5458\u548c\u5de5\u5177\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u8ba1\u5212Planning<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9a8c\u8bc1\u7684\u89c4\u5212\u8d2f\u7a7f\u6574\u4e2a\u9879\u76ee\u751f\u547d\u5468\u671f\u3002\u60a8\u5c06\u5236\u5b9a\u5305\u542b\u5173\u952e\u91cc\u7a0b\u7891\u7684\u6d4b\u8bd5\u8ba1\u5212\u3002\u6bcf\u5f53\u5bf9\u8bbe\u8ba1\u8f93\u5165\u8fdb\u884c\u66f4\u6539\u65f6\uff0c\u5fc5\u987b\u66f4\u65b0\u8be5\u8ba1\u5212\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5f00\u53d1Developing<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ea7\u54c1\u5f00\u53d1\u5f00\u59cb\uff01\u91c7\u7528\u6240\u9009\u7684\u65b9\u6cd5\u8bba\uff08Scrum\u3001\u7011\u5e03\u3001\u6df7\u5408\u7b49\uff09\u8fdb\u884c\u3002\u672c\u9636\u6bb5\u8fd8\u5305\u62ec\u7f16\u5199\u3001\u8bd5\u8fd0\u884c\u5e76\u6279\u51c6\u5c06\u7528\u4e8e\u9a8c\u8bc1\u7684\u6d4b\u8bd5\u7528\u4f8b\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u6267\u884cExecuting<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u6309\u7167\u8ba1\u5212\u6267\u884c\u6d4b\u8bd5\u7a0b\u5e8f\u3002\u4efb\u4f55\u65e0\u6548\u7ed3\u679c\u5747\u4e88\u8bb0\u5f55\u5e76\u590d\u6838\uff0c\u968f\u540e\u88ab\u63a5\u53d7\u6216\u8bb0\u5f55\u4e3a\u7f3a\u9677\u3002\u4ea7\u54c1\u4e2d\u7684\u7f3a\u9677\u88ab\u89e3\u51b3\u5e76\u53d1\u5e03\uff0c\u540c\u65f6\u6267\u884c\u56de\u5f52\u6d4b\u8bd5\u3002\u521b\u5efa\u53ef\u8ffd\u6eaf\u77e9\u9635\u4ee5\u9a8c\u8bc1\u5728\u9a8c\u8bc1\u6d4b\u8bd5\u8ba1\u5212\u4e2d\u8bc6\u522b\u7684\u8bbe\u8ba1\u8f93\u5165\u5df2\u88ab\u6d4b\u8bd5\u5e76\u901a\u8fc7\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u62a5\u544aReporting<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u6bcf\u4e2a\u9a8c\u8bc1\u9636\u6bb5\u7ed3\u675f\u65f6\u8fdb\u884c\u62a5\u544a\u3002\u8be6\u7ec6\u62a5\u544a\u5305\u62ec\u914d\u7f6e\u7ba1\u7406\u548c\u53d1\u5e03\u62a5\u544a\u3001\u6309\u6d4b\u8bd5\u7c7b\u578b\u6216\u4ea7\u54c1\u7248\u672c\u5206\u7c7b\u7684\u6d4b\u8bd5\u7ed3\u679c\uff0c\u4ee5\u53ca\u5728\u9a8c\u8bc1\u6d3b\u52a8\u4e2d\u53d1\u73b0\u7684\u95ee\u9898\u3002\u8bbe\u8ba1\u9a8c\u8bc1\u53ef\u8ffd\u6eaf\u6027\u62a5\u544a\u663e\u793a\u9700\u6c42\u7684\u6d4b\u8bd5\u7ed3\u679c\u548c\u8986\u76d6\u60c5\u51b5\u3002\u6700\u540e\uff0c\u6bcf\u6b21\u8bbe\u8ba1\u9a8c\u8bc1\u6d3b\u52a8\u540e\u5b8c\u6210\u5e76\u6279\u51c6\u8bc4\u5ba1\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u505a\u597d\u8bbe\u8ba1\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u76846\u4e2a\u5efa\u8bae<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u4e0b\u63d0\u793a\u53ef\u5e2e\u52a9\u60a8\u5728\u8bbe\u8ba1\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u4e2d\u83b7\u5f97\u6700\u5927\u6536\u76ca\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u63d0\u524d\u89c4\u5212\uff08\u5e76\u5c3d\u65e9\u6d4b\u8bd5\uff09<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u524d\u671f\u5236\u5b9a\u53ef\u9760\u7684\u8ba1\u5212\u5e76\u8ba9\u6240\u6709\u4eba\u53c2\u4e0e\u3002\u5f00\u53d1\u8ba1\u5212\u4e2d\u5e94\u5c3d\u65e9\u5305\u542b\u6d4b\u8bd5\u5de5\u7a0b\u5e08\uff0c\u4ee5\u786e\u4fdd\u9700\u6c42\u548c\u8bbe\u8ba1\u6e05\u6670\u3001\u5b8c\u6574\u4e14\u53ef\u6d4b\u8bd5\u3002\u5218\u8001\u5e08\u8868\u793a\uff1a\u201c\u5c3d\u65e9\u5f00\u53d1\u6d4b\u8bd5\u65b9\u6cd5\u53ef\u4ee5\u5728\u6280\u672f\u95ee\u9898\u6210\u4e3a\u91cd\u5927\u969c\u788d\u4e4b\u524d\u63ed\u793a\u5b83\u4eec\u3002\u201d\u5c3d\u65e9\u7684\u6d4b\u8bd5\u5f00\u53d1\u8fd8\u53ef\u4ee5\u63d0\u4f9b\u6d4b\u8bd5\u5de5\u5177\uff0c\u8fd9\u4e9b\u5de5\u5177\u53ef\u7528\u4e8e\u52a0\u901f\u4ea7\u54c1\u5f00\u53d1\u6d41\u7a0b\uff0c\u5e76\u5728\u6b63\u5f0f\u6d4b\u8bd5\u671f\u95f4\u63d0\u4f9b\u6d4b\u8bd5\u8bc1\u636e\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u4f7f\u7528\u7edf\u4e00\u672f\u8bed<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u8ba9\u56e2\u961f\u8fbe\u6210\u5171\u8bc6\u5bf9\u6210\u529f\u7684\u8bbe\u8ba1\u9a8c\u8bc1\u4e0e\u8bbe\u8ba1\u786e\u8ba4\u81f3\u5173\u91cd\u8981\u3002\u8fbe\u6210\u5171\u8bc6\u7684\u4e00\u90e8\u5206\u5c31\u662f\u4f7f\u7528\u7edf\u4e00\u7684\u672f\u8bed\u3002\u4f7f\u7528\u76f8\u540c\u7684\u672f\u8bed\u53ef\u4ee5\u6d88\u9664\u56e2\u961f\u6210\u5458\u7684\u6df7\u6dc6\uff08\u4e0d\u4ec5\u662f\u65b0\u6210\u5458\u2014\u2014\u8d44\u6df1\u6210\u5458\u4e5f\u662f\u5982\u6b64\uff09\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">3. \u4f7f\u7528\u5177\u6709\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027\u7684\u5de5\u5177<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5728\u6700\u7b80\u5355\u7684\u60c5\u51b5\u4e0b\uff0c\u53ef\u4ee5\u4f7f\u7528 Word \u6587\u6863\u548c\u7535\u5b50\u8868\u683c\u6765\u5b9e\u73b0\u53ef\u8ffd\u6eaf\u6027\uff0c\u4f46\u5b83\u4eec\u4f1a\u4ea7\u751f\u5927\u91cf\u624b\u5de5\u5de5\u4f5c\uff08\u4e14\u5bb9\u6613\u51fa\u9519\uff09\uff0c\u8ba9\u4f60\u4f1a\u540e\u6094\u6ca1\u6709\u4e00\u5f00\u59cb\u5c31\u4f7f\u7528\u4e13\u7528\u5de5\u5177\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u201c<\/em><em>\u5728\u8fdb\u884c\u56de\u5f52\u5206\u6790\u4ee5\u786e\u5b9a\u5728\u4ea7\u54c1\u66f4\u6539\u6216\u4fee\u590d\u7f3a\u9677\u540e\u5e94\u91cd\u65b0\u6d4b\u8bd5\u7684\u5185\u5bb9\u65f6\uff0c\u51c6\u786e\u7684\u8ffd\u8e2a\u77e9\u9635\u662f\u975e\u5e38\u5b9d\u8d35\u7684\u3002<\/em><em>\u201d\u2014\u2014<\/em><em>\u5218\u8001\u5e08\uff0c\u9a8c\u8bc1\u4e0e\u786e\u8ba4\u987e\u95ee<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f7f\u7528\u5177\u6709\u5f3a\u5927\u9700\u6c42-\u6d4b\u8bd5-\u7ed3\u679c\u8ffd\u8e2a\u529f\u80fd\u7684\u5de5\u5177\u5c06\u5e2e\u52a9\u4f60\u8bc6\u522b\u8986\u76d6\u4e2d\u7684\u7a7a\u767d\uff0c\u5e76\u5728\u4ea7\u54c1\u4e2d\u8106\u5f31\u6216\u672a\u6d4b\u8bd5\u7684\u533a\u57df\u63d0\u4f9b\u65e9\u671f\u8b66\u793a\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.perforce.com\/sites\/default\/files\/inline-images\/End-to-end_Trace_Report_0.png\"><\/a>\u5177\u6709\u7aef\u5230\u7aef\u53ef\u8ffd\u6eaf\u6027\u7684\u5de5\u5177\u7b80\u5316\u4e86\u5668\u68b0\u5f00\u53d1\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">4. \u5728\u8fdb\u884c\u4e2d\u6784\u5efa\u60a8\u7684\u8ffd\u8e2a\u77e9\u9635<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u201c\u53ef\u80fd\u4f1a\u5f88\u60f3\u628a\u5b83\u63a8\u8fdf\uff0c\u4f46\u4e0d\u8981\u7b49\u7740\u518d\u53bb\u5efa\u7acb\u4f60\u7684\u8ffd\u6eaf\u77e9\u9635\u3002\u201d&#8211;\u5218\u8001\u5e08\u8bf4\u3002\u968f\u7740\u8fdb\u5c55\u6784\u5efa\u4f60\u7684\u53ef\u8ffd\u6eaf\u6027\u53ef\u4ee5\u9632\u6b62\u6f0f\u6d1e\u5728\u4e0d\u88ab\u5bdf\u89c9\u7684\u60c5\u51b5\u4e0b\u5f62\u6210\u3002\u5f88\u5c11\u6709\u4e8b\u60c5\u6bd4\u5728\u4f60\u4ee5\u4e3a\u5f00\u53d1\u5de5\u4f5c\u5df2\u5b8c\u6210\u65f6\u624d\u53d1\u73b0\u4f60\u6f0f\u6389\u4e86\u5173\u952e\u9700\u6c42\u3001\u51cf\u8f7b\u98ce\u9669\u7684\u529f\u80fd\u6216\u5fc5\u8981\u6d4b\u8bd5\u66f4\u96be\u4ee5\u633d\u56de\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u9700\u6c42\u3001\u8bbe\u8ba1\u548c\u6d4b\u8bd5\u6f14\u8fdb\u7684\u8fc7\u7a0b\u4e2d\uff0c\u4fdd\u6301\u53ef\u8ffd\u6eaf\u6027\u6240\u9700\u7684\u7ef4\u62a4\u5de5\u4f5c\u8981\u8fdc\u8fdc\u5c11\u4e8e\u5728\u6700\u540e\u5173\u5934\u4fee\u8865\u8bbe\u8ba1\u548c\u5f00\u53d1\u4e2d\u7684\u5173\u952e\u6f0f\u6d1e\u3002\u8fd9\u9879\u5de5\u4f5c\u8fd8\u80fd\u5e2e\u52a9\u4f60\u8bc6\u522b\u8fd8\u5269\u591a\u5c11\u5de5\u4f5c\u91cf\u3001\u4f55\u5904\u53ef\u80fd\u9700\u8981\u589e\u52a0\u5f00\u53d1\u6216\u6d4b\u8bd5\u4eba\u5458\uff0c\u6216\u8005\u4f55\u65f6\u5e94\u91cd\u65b0\u8bc4\u4f30\u4ea4\u4ed8\u8ba1\u5212\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u907f\u514d\u5728\u6700\u540e\u4e00\u523b\u51fa\u73b0\u7d27\u6025\u60c5\u51b5\uff01\u5728\u6b64\uff0cPerforce ALM \u4e2d\u8ddf\u8e2a\u9700\u6c42\u4e0e\u5df2\u5b8c\u6210\u6d4b\u8bd5\u4e4b\u95f4\u7684\u72b6\u6001\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5. \u5c06\u9700\u6c42\u53ef\u8ffd\u6eaf\u6027\u4e0e\u6d4b\u8bd5\u4e0e\u5f02\u5e38\u8ddf\u8e2a\u96c6\u6210<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u80fd\u591f\u5c06\u5f02\u5e38\u76f4\u63a5\u4e0e\u9700\u6c42\u5173\u8054\u53ef\u6539\u5584\u6d4b\u8bd5\u4eba\u5458\u4e0e\u5f00\u53d1\u4eba\u5458\u4e4b\u95f4\u7684\u6c9f\u901a\u3002\u8fd9\u975e\u5e38\u6709\u5e2e\u52a9\u3002\u76f4\u63a5\u4ece\u6d4b\u8bd5\u65b9\u6848\u5931\u8d25\u751f\u6210\u5f02\u5e38\u610f\u5473\u7740\u4f1a\u6355\u83b7\u6709\u5173\u95ee\u9898\u7684\u66f4\u591a\u7ec6\u8282\u3002\u56e0\u6b64\uff0c\u95ee\u9898\u53ef\u4ee5\u66f4\u5bb9\u6613\u5730\u8bb0\u5f55\u3001\u91cd\u73b0\u3001\u4fee\u590d\u548c\u91cd\u65b0\u6d4b\u8bd5\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">6. \u9009\u62e9\u53ef\u6839\u636e\u60a8\u7684\u65b9\u6cd5\u8fdb\u884c\u81ea\u5b9a\u4e49\u7684\u5de5\u5177<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u201c<\/strong>\u65e0\u8bba\u60a8\u9009\u62e9\u4e86\u54ea\u79cd\u5f00\u53d1\u6a21\u578b\u2014\u2014\u654f\u6377\u3001\u8fed\u4ee3\u3001\u6539\u826f\u7011\u5e03\u2014\u2014\u60a8\u90fd\u5e94\u9009\u62e9\u90a3\u4e9b\u80fd\u901a\u8fc7\u9002\u5e94\u60a8\u7684\u6d41\u7a0b\u6765\u4e3a\u60a8\u670d\u52a1\u7684 V&amp;V \u5de5\u5177\uff0c\u800c\u4e0d\u662f\u8feb\u4f7f\u60a8\u4e3a\u5de5\u5177\u800c\u8c03\u6574\u6d41\u7a0b\uff0c\u201d\u5218\u8001\u5e08\u5efa\u8bae\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u5c06\u8fd9\u4e00\u5207\u6c47\u805a\u5728\u4e00\u8d77<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u8bbe\u8ba1\u786e\u8ba4\u548c\u8bbe\u8ba1\u9a8c\u8bc1\u662f\u6210\u529f\u5668\u68b0\u5f00\u53d1\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\u3002\u5f53\u56e2\u961f\u4e4b\u95f4\u6709\u5171\u540c\u7684\u7406\u89e3\u5e76\u914d\u5907\u5408\u9002\u7684\u5de5\u5177\u65f6\uff0c\u60a8\u5c31\u62e5\u6709\u5c06\u5668\u68b0\u63a8\u5411\u5e02\u573a\u7684\u575a\u5b9e\u6846\u67b6\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u518d\u6b21\u611f\u8c22\u9a8c\u8bc1\u4e0e\u786e\u8ba4\uff08<\/em><em>V &amp; V<\/em><em>\uff09\u4e13\u5bb6<\/em><em> <\/em><em>\u5218\u8001\u5e08<\/em><em> <\/em><em>\u4e3a\u672c\u6587\u63d0\u4f9b\u7684\u5b9d\u8d35\u89c1\u89e3\uff01<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u8bbe\u8ba1\u9a8c\u8bc1\u4e0e\u8bbe\u8ba1\u786e\u8ba4\u5728\u533b\u7597\u5668\u68b0\u5f00\u53d1\u4e2d\u7684\u533a\u522b Desig<span class=\"excerpt-hellip\"> [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-63","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=\/wp\/v2\/posts\/63","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=63"}],"version-history":[{"count":4,"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=\/wp\/v2\/posts\/63\/revisions"}],"predecessor-version":[{"id":73,"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=\/wp\/v2\/posts\/63\/revisions\/73"}],"wp:attachment":[{"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=63"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=63"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.renewyou.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=63"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}