{"id":121299,"date":"2026-11-02T12:56:38","date_gmt":"2026-11-02T04:56:38","guid":{"rendered":"https:\/\/www.wsisp.com\/helps\/121299.html"},"modified":"2026-11-02T12:56:38","modified_gmt":"2026-11-02T04:56:38","slug":"%e7%94%a8%e6%88%b7%e9%9c%80%e6%b1%82%e8%af%b4%e6%98%8e-urs-%e5%86%99%e6%88%90%e5%bd%a2%e5%ae%b9%e8%af%8d%ef%bc%8c%e9%aa%8c%e6%94%b6%e6%97%b6%e6%b2%a1%e4%b8%80%e6%9d%a1%e8%83%bd%e5%88%a4%e5%af%b9","status":"publish","type":"post","link":"https:\/\/www.wsisp.com\/helps\/121299.html","title":{"rendered":"\u7528\u6237\u9700\u6c42\u8bf4\u660e URS \u5199\u6210\u5f62\u5bb9\u8bcd\uff0c\u9a8c\u6536\u65f6\u6ca1\u4e00\u6761\u80fd\u5224\u5bf9\u9519"},"content":{"rendered":"<p><img decoding=\"async\" alt=\"\u9700\u6c42\u5199\u6210\u5f62\u5bb9\u8bcd\uff0c\u4e09\u5bb6\u4ef7\u683c\u5dee\u4e09\u500d\" src=\"https:\/\/www.wsisp.com\/helps\/wp-content\/uploads\/2026\/11\/20261102045634-6ae8180294e0a.png\" \/><\/p>\n<p>2018 \u5e74\u90a3\u5957 LIMS&#xff08;\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf&#xff0c;Laboratory Information Management System&#xff09;\u9009\u578b&#xff0c;\u6211\u628a URS&#xff08;\u7528\u6237\u9700\u6c42\u8bf4\u660e&#xff0c;User Requirements Specification&#xff09;\u53d1\u7ed9\u4e09\u5bb6\u4f9b\u5e94\u5546&#xff0c;\u56de\u6807\u4ef7\u683c\u5dee\u4e86\u5c06\u8fd1\u4e09\u500d\u3002\u91c7\u8d2d\u62ff\u7740\u4e09\u4efd\u6807\u4e66\u56de\u5934\u95ee\u6211\u4e00\u53e5&#xff1a;\u4e09\u5bb6\u62a5\u7684\u4e0d\u662f\u4e00\u4e2a\u4e1c\u897f\u5417&#xff1f;<\/p>\n<p>\u6211\u7ed9\u4ef7\u683c\u6700\u4f4e\u90a3\u5bb6\u6253\u7535\u8bdd&#xff0c;\u95ee\u4e3a\u4ec0\u4e48\u8fd9\u4e48\u4f4e\u3002\u4ed6\u8bf4&#xff1a;\u4f60\u4eec\u5199\u300c\u754c\u9762\u53cb\u597d\u3001\u64cd\u4f5c\u7b80\u4fbf\u300d&#xff0c;\u6211\u4eec\u5c31\u6309\u6807\u51c6\u529f\u80fd\u4f30\u7684\u3002<\/p>\n<p>\u90a3\u4e00\u95ee\u6211\u624d\u660e\u767d&#xff0c;\u95ee\u9898\u4e0d\u5728\u4f9b\u5e94\u5546&#xff0c;\u5728\u6211\u90a3\u4efd URS\u2014\u2014\u5199\u6ee1\u4e86\u5f62\u5bb9\u8bcd&#xff0c;\u6ca1\u6709\u4e00\u6761\u80fd\u5224\u5bf9\u9519\u3002<\/p>\n<h3>\u6cd5\u89c4\u8981\u7684\u662f\u300c\u53ef\u8ffd\u6eaf\u7684\u9700\u6c42\u300d&#xff0c;\u4e0d\u662f\u4e00\u6bb5\u63cf\u8ff0<\/h3>\n<p>GMP&#xff08;\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303&#xff09;\u9644\u5f55\u300a\u786e\u8ba4\u4e0e\u9a8c\u8bc1\u300b&#xff08;2015 \u5e74\u53d1\u5e03&#xff0c;2015-12-01 \u65bd\u884c&#xff09;\u628a\u8bbe\u8ba1\u786e\u8ba4\u7684\u8d77\u70b9\u6307\u5411\u7528\u6237\u9700\u6c42&#xff1a;\u8bbe\u8ba1\u8981\u9010\u9879\u5bf9\u7167\u9700\u6c42\u505a\u786e\u8ba4\u3002<\/p>\n<p>\u9644\u5f55\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u300b&#xff08;2015 \u5e74\u53d1\u5e03&#xff0c;2015-12-01 \u65bd\u884c&#xff09;\u8981\u6c42\u7cfb\u7edf\u9700\u6c42\u5728\u751f\u547d\u5468\u671f\u5185\u4fdd\u6301\u53ef\u8ffd\u6eaf\u3002<\/p>\n<p>EU GMP Annex 11&#xff08;\u6b27\u76df GMP \u9644\u5f55 11&#xff0c;2011-06-30 \u751f\u6548&#xff09;\u7b2c 4 \u7ae0 Validation \u91cc\u6709\u4e00\u6761\u4e13\u95e8\u8bb2\u7528\u6237\u9700\u6c42\u8bf4\u660e&#xff0c;\u8981\u6c42\u5b83\u63cf\u8ff0\u7cfb\u7edf\u5fc5\u987b\u5177\u5907\u7684\u529f\u80fd&#xff0c;\u5e76\u4fdd\u6301\u53ef\u8ffd\u6eaf\u3002<\/p>\n<p>\u8981\u5b58\u7535\u5b50\u8bb0\u5f55\u3001\u8981\u7528\u7535\u5b50\u7b7e\u540d&#xff0c;\u5c31\u5f97\u628a 21 CFR Part 11&#xff08;1997-08-20 \u751f\u6548&#xff09;\u7684\u8981\u6c42\u62c6\u6210\u6761\u76ee\u5199\u8fdb URS&#xff0c;\u4e0d\u80fd\u53ea\u5199\u4e00\u53e5\u300c\u7b26\u5408 Part 11\u300d\u3002<\/p>\n<p>GAMP 5 \u7b2c\u4e8c\u7248&#xff08;ISPE&#xff0c;2022 \u5e74\u53d1\u5e03&#xff09;\u628a\u9700\u6c42\u89c4\u683c\u653e\u5728\u300c\u80fd\u8ffd\u6eaf\u5230\u8bbe\u8ba1\u3001\u80fd\u5bf9\u5e94\u5230\u6d4b\u8bd5\u300d\u7684\u4f4d\u7f6e\u4e0a\u3002<\/p>\n<p>\u56db\u4efd\u6587\u4ef6\u8bf4\u7684\u662f\u540c\u4e00\u4ef6\u4e8b&#xff1a;\u9700\u6c42\u4e0d\u662f\u5199\u7ed9\u4f9b\u5e94\u5546\u770b\u7684\u8bf4\u660e&#xff0c;\u662f\u540e\u9762\u6bcf\u4efd\u6587\u4ef6\u90fd\u8981\u56de\u5934\u5bf9\u7684\u90a3\u6761\u7ebf\u3002<\/p>\n<h3>\u4e09\u79cd\u5199\u6cd5&#xff0c;\u9519\u5728\u540c\u4e00\u4e2a\u5730\u65b9<\/h3>\n<p>\u7b2c\u4e00\u79cd&#xff0c;\u5f62\u5bb9\u8bcd\u5806\u780c\u3002<\/p>\n<p>\u300c\u754c\u9762\u53cb\u597d\u300d\u300c\u64cd\u4f5c\u7b80\u4fbf\u300d\u300c\u6027\u80fd\u7a33\u5b9a\u300d\u300c\u7b26\u5408\u6cd5\u89c4\u8981\u6c42\u300d\u3002\u8fd9\u7c7b\u8bdd\u4f9b\u5e94\u5546\u7167\u6284\u56de\u4f60\u7684\u6807\u4e66&#xff0c;\u770b\u7740\u4e00\u5b57\u4e0d\u5dee&#xff0c;\u5176\u5b9e\u4ec0\u4e48\u90fd\u6ca1\u627f\u8bfa\u3002<\/p>\n<p>\u7b2c\u4e8c\u79cd&#xff0c;\u62ff\u4f9b\u5e94\u5546\u7684\u529f\u80fd\u6e05\u5355\u5012\u586b\u3002<\/p>\n<p>\u5148\u628a\u4e09\u5bb6\u6f14\u793a\u770b\u5b8c&#xff0c;\u518d\u628a\u4ed6\u4eec\u7684\u529f\u80fd\u5217\u8868\u6539\u6210\u300c\u6211\u65b9\u9700\u6c42\u300d\u3002\u8fd9\u6837\u5199\u51fa\u6765\u7684\u4e00\u5b9a\u505a\u5f97\u51fa\u6765&#xff0c;\u95ee\u9898\u662f&#xff1a;\u4f60\u5bb6\u6d41\u7a0b\u91cc\u90a3\u4e9b\u7279\u6b8a\u7684\u5730\u65b9&#xff0c;\u4e00\u6761\u90fd\u6ca1\u8fdb\u53bb\u3002<\/p>\n<p>\u7b2c\u4e09\u79cd&#xff0c;\u53ea\u5199\u529f\u80fd&#xff0c;\u4e0d\u5199\u7ea6\u675f\u3002<\/p>\n<p>\u529f\u80fd\u5199\u4e86\u4e09\u5341\u6761&#xff0c;\u6570\u636e\u91cf\u3001\u5e76\u53d1\u4eba\u6570\u3001\u63a5\u53e3\u534f\u8bae\u3001\u5ba1\u8ba1\u8ffd\u8e2a\u7559\u51e0\u5e74\u3001\u62a5\u8868\u683c\u5f0f&#xff0c;\u4e00\u53e5\u6ca1\u6709\u3002\u4f9b\u5e94\u5546\u6309\u529f\u80fd\u4f30&#xff0c;\u8fd9\u4e9b\u5168\u7b97\u300c\u5305\u542b\u5728\u5185\u300d&#xff0c;\u4e0a\u7ebf\u524d\u9010\u9879\u52a0\u94b1\u3002<\/p>\n<p>\u4e09\u79cd\u9519\u6cd5\u4e00\u4e2a\u6839\u5b50&#xff1a;\u628a URS \u5f53\u6210\u300c\u5411\u4f9b\u5e94\u5546\u63d0\u8981\u6c42\u300d&#xff0c;\u6ca1\u5f53\u6210\u300c\u81ea\u5df1\u9a8c\u6536\u65f6\u7684\u5224\u636e\u300d\u3002<\/p>\n<h3>\u6362\u4e2a\u5199\u6cd5&#xff1a;\u6bcf\u6761\u9700\u6c42\u90fd\u8981\u80fd\u8bbe\u8ba1\u51fa\u4e00\u4e2a\u6d4b\u8bd5<\/h3>\n<p>\u8fd9\u5957\u6d3b\u513f\u53eb\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1&#xff08;CSV&#xff0c;Computerized System Validation&#xff09;\u3002URS \u662f\u5b83\u7684\u7b2c\u4e00\u4efd\u8f93\u5165\u6587\u4ef6&#xff0c;\u5199\u6b6a\u4e00\u4e2a\u5b57&#xff0c;\u540e\u9762 IQ&#xff08;\u5b89\u88c5\u786e\u8ba4&#xff09;\u3001OQ&#xff08;\u8fd0\u884c\u786e\u8ba4&#xff09;\u3001PQ&#xff08;\u6027\u80fd\u786e\u8ba4&#xff09;\u5168\u8ddf\u7740\u6b6a\u3002<\/p>\n<p>\u7b2c\u4e00\u6b65&#xff0c;\u5148\u5217\u6d41\u7a0b&#xff0c;\u4e0d\u5217\u529f\u80fd\u3002<\/p>\n<p>\u628a\u300c\u8c01\u5728\u4ec0\u4e48\u5c97\u4f4d\u3001\u62ff\u4ec0\u4e48\u6570\u636e\u3001\u505a\u5b8c\u8fd9\u4e00\u6b65\u4ea4\u7ed9\u8c01\u300d\u5199\u6210\u6d41\u7a0b\u6e05\u5355&#xff0c;\u4e00\u6761\u6d41\u7a0b\u4e00\u884c&#xff0c;\u6ce8\u660e\u4ea7\u51fa\u4ec0\u4e48\u8bb0\u5f55\u3002<\/p>\n<p>\u4e3a\u4ec0\u4e48&#xff1a;\u6f0f\u529f\u80fd\u6700\u5e38\u89c1\u7684\u5f62\u6001\u4e0d\u662f\u5fd8\u4e86\u5199&#xff0c;\u662f\u538b\u6839\u4e0d\u77e5\u9053\u6709\u8fd9\u4e2a\u73af\u8282\u3002<\/p>\n<p>\u7b2c\u4e8c\u6b65&#xff0c;\u6bcf\u6761\u9700\u6c42\u7528\u540c\u4e00\u4e2a\u53e5\u5f0f\u5199\u3002<\/p>\n<p>\u300c\u7cfb\u7edf\u5e94\u80fd\u3008\u52a8\u4f5c\u3009\u3008\u5bf9\u8c61\u3009&#xff0c;\u3008\u5224\u5b9a\u6761\u4ef6\u3009\u300d\u3002\u5224\u5b9a\u6761\u4ef6\u5fc5\u987b\u662f\u80fd\u67e5\u7684&#xff1a;\u5b57\u6bb5\u957f\u5ea6\u3001\u65f6\u95f4\u8303\u56f4\u3001\u5fc5\u586b\u9879\u3001\u5141\u8bb8\u7684\u89d2\u8272\u3001\u54cd\u5e94\u79d2\u6570\u3002<\/p>\n<p>\u4e3a\u4ec0\u4e48&#xff1a;\u5224\u5b9a\u6761\u4ef6\u5c31\u662f\u9a8c\u6536\u65f6\u7684\u5224\u636e\u3002\u5199\u4e0d\u51fa\u5224\u5b9a\u6761\u4ef6&#xff0c;\u8bf4\u660e\u8fd9\u6761\u9700\u6c42\u8fd8\u6ca1\u60f3\u6e05\u3002<\/p>\n<p><img decoding=\"async\" alt=\"\u56db\u7c7b\u9700\u6c42\u7684\u6539\u6cd5\uff1a\u4ece\u5f62\u5bb9\u8bcd\u5230\u5224\u5b9a\u6761\u4ef6\" src=\"https:\/\/www.wsisp.com\/helps\/wp-content\/uploads\/2026\/11\/20261102045636-6ae8180446061.png\" \/><\/p>\n<p>\u7b2c\u4e09\u6b65&#xff0c;\u7ed9\u6bcf\u6761\u9700\u6c42\u7f16\u53f7\u548c\u4f18\u5148\u7ea7\u3002<\/p>\n<p>\u7f16\u53f7\u53d6\u300cURS-\u6a21\u5757-\u5e8f\u53f7\u300d&#xff0c;\u4f18\u5148\u7ea7\u5206\u4e09\u6863&#xff1a;\u5fc5\u987b\u3001\u5e94\u8be5\u3001\u53ef\u4ee5\u3002<\/p>\n<p>\u4e3a\u4ec0\u4e48&#xff1a;\u4f9b\u5e94\u5546\u6309\u300c\u5fc5\u987b\u300d\u4f30&#xff0c;\u53e6\u4e24\u6863\u7559\u4f5c\u8c08\u4ef7\u7a7a\u95f4&#xff1b;\u6ca1\u6709\u4f18\u5148\u7ea7&#xff0c;\u780d\u9700\u6c42\u65f6\u53ea\u80fd\u51ed\u611f\u89c9\u780d\u3002<\/p>\n<p>\u7b2c\u56db\u6b65&#xff0c;\u628a\u975e\u529f\u80fd\u7ea6\u675f\u5355\u5217\u4e00\u8282\u3002<\/p>\n<p>\u6570\u636e\u91cf\u3001\u5e76\u53d1\u7528\u6237\u6570\u3001\u63a5\u53e3\u6e05\u5355&#xff08;\u542b\u534f\u8bae\u4e0e\u9891\u7387&#xff09;\u3001\u6743\u9650\u89d2\u8272\u3001\u5ba1\u8ba1\u8ffd\u8e2a\u8303\u56f4\u4e0e\u4fdd\u7559\u671f\u3001\u5907\u4efd\u4e0e\u6062\u590d\u3001\u62a5\u8868\u8f93\u51fa\u683c\u5f0f&#xff08;\u542b\u6253\u5370\u6a21\u677f&#xff09;\u3002\u4e03\u7c7b\u5404\u5199\u4e00\u6bb5\u3002<\/p>\n<p>\u4e3a\u4ec0\u4e48&#xff1a;\u8fd9\u4e03\u7c7b\u662f\u4ef7\u683c\u91cc\u6700\u5bb9\u6613\u53d8\u6210\u300c\u53e6\u5916\u8ba1\u8d39\u300d\u7684\u90e8\u5206&#xff0c;\u4e5f\u662f\u68c0\u67e5\u65f6\u6700\u5bb9\u6613\u88ab\u8ffd\u95ee\u7684\u90e8\u5206\u3002<\/p>\n<p>\u7b2c\u4e94\u6b65&#xff0c;\u5199\u5b8c\u505a\u4e00\u6b21\u53ef\u6d4b\u6027\u81ea\u68c0\u3002<\/p>\n<p>\u9010\u6761\u95ee&#xff1a;\u8fd9\u6761\u9700\u6c42&#xff0c;\u6211\u80fd\u8bbe\u8ba1\u51fa\u4e00\u4e2a\u6d4b\u8bd5\u7528\u4f8b\u5417&#xff1f;\u80fd\u5224\u901a\u8fc7\u6216\u5931\u8d25\u5417&#xff1f;\u7b54\u4e0d\u51fa\u5c31\u9000\u56de\u91cd\u5199\u3002<\/p>\n<p>\u4e3a\u4ec0\u4e48&#xff1a;URS \u5199\u4e0d\u6e05&#xff0c;\u6d4b\u8bd5\u7528\u4f8b\u4e00\u5b9a\u5199\u5f97\u7cca&#xff1b;\u7528\u4f8b\u7cca&#xff0c;OQ \u5c31\u53d8\u6210\u8d70\u8fc7\u573a\u3002<\/p>\n<h3>\u4ea4\u4ed8\u4ef6&#xff1a;URS \u9aa8\u67b6 &#043; \u53ef\u6d4b\u6027\u81ea\u68c0 10 \u95ee<\/h3>\n<p>\u8868\u4e00\u662f\u9aa8\u67b6&#xff0c;\u4e00\u8282\u4e00\u9875&#xff0c;\u586b\u5b8c\u5c31\u662f\u4e00\u4efd\u80fd\u53d1\u6807\u7684 URS\u3002\u7b2c\u4e09\u5217\u662f\u88ab\u4f9b\u5e94\u5546\u9876\u56de\u6765\u8fc7\u7684\u5199\u6cd5\u3002<\/p>\n<table>\n<tr>\u7ae0\u8282\u5fc5\u987b\u5199\u7684\u4e00\u53e5\u8bdd\u6700\u5bb9\u6613\u88ab\u9876\u56de<\/tr>\n<tbody>\n<tr>\n<td>1 \u76ee\u7684\u4e0e\u8303\u56f4<\/td>\n<td>\u672c\u6587\u4ef6\u9002\u7528\u4e8e XX \u7cfb\u7edf&#xff0c;\u8986\u76d6 A\/B\/C \u4e09\u4e2a\u6d41\u7a0b&#xff0c;\u4e0d\u542b D<\/td>\n<td>\u53ea\u5199\u7cfb\u7edf\u540d<\/td>\n<\/tr>\n<tr>\n<td>2 \u6d41\u7a0b\u4e0e\u89d2\u8272<\/td>\n<td>\u5171 N \u6761\u6d41\u7a0b&#xff0c;\u6bcf\u6761\u6ce8\u660e\u53d1\u8d77\u5c97\u4f4d\u3001\u5ba1\u6279\u5c97\u4f4d\u3001\u4ea7\u51fa\u8bb0\u5f55<\/td>\n<td>\u5199\u6210\u90e8\u95e8\u5217\u8868<\/td>\n<\/tr>\n<tr>\n<td>3 \u529f\u80fd\u9700\u6c42<\/td>\n<td>\u6309 URS-\u6a21\u5757-\u5e8f\u53f7\u7f16\u53f7&#xff0c;\u53e5\u5f0f\u7edf\u4e00&#xff0c;\u6bcf\u6761\u5e26\u5224\u5b9a\u6761\u4ef6<\/td>\n<td>\u53ea\u5199\u529f\u80fd\u540d<\/td>\n<\/tr>\n<tr>\n<td>4 \u975e\u529f\u80fd\u7ea6\u675f<\/td>\n<td>\u6570\u636e\u91cf\u3001\u5e76\u53d1\u3001\u63a5\u53e3\u3001\u6743\u9650\u3001\u5ba1\u8ba1\u8ffd\u8e2a\u3001\u5907\u4efd\u3001\u62a5\u8868\u4e03\u7c7b\u5404\u4e00\u6bb5<\/td>\n<td>\u6574\u8282\u7f3a\u5931<\/td>\n<\/tr>\n<tr>\n<td>5 \u6570\u636e\u4e0e\u8bb0\u5f55<\/td>\n<td>\u4ea7\u751f\u54ea\u4e9b\u8bb0\u5f55\u3001\u4fdd\u5b58\u51e0\u5e74\u3001\u4ee5\u4ec0\u4e48\u5f62\u5f0f\u4fdd\u5b58\u3001\u8c01\u53ef\u4fee\u6539<\/td>\n<td>\u53ea\u5199\u300c\u7b26\u5408\u6cd5\u89c4\u300d<\/td>\n<\/tr>\n<tr>\n<td>6 \u63a5\u53e3\u6e05\u5355<\/td>\n<td>\u6bcf\u4e2a\u63a5\u53e3\u5199\u65b9\u5411\u3001\u534f\u8bae\u3001\u9891\u7387\u3001\u5931\u8d25\u5904\u7406<\/td>\n<td>\u53ea\u5199\u300c\u53ef\u4e0e XX \u5bf9\u63a5\u300d<\/td>\n<\/tr>\n<tr>\n<td>7 \u5047\u8bbe\u4e0e\u8fb9\u754c<\/td>\n<td>\u672c\u671f\u4e0d\u505a\u7684\u4e8b\u3001\u4f9d\u8d56\u7532\u65b9\u5148\u63d0\u4f9b\u7684\u4e1c\u897f<\/td>\n<td>\u4e0d\u5199&#xff0c;\u540e\u671f\u626f\u76ae<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u8868\u4e8c\u8fd9 10 \u95ee&#xff0c;\u4efb\u4e00\u6761\u7b54\u4e0d\u4e0a&#xff0c;\u8fd9\u6761\u9700\u6c42\u5c31\u8fd8\u4e0d\u80fd\u53d1\u51fa\u53bb\u3002<\/p>\n<li>\u8fd9\u6761\u9700\u6c42\u80fd\u5199\u51fa\u4e00\u6761\u6d4b\u8bd5\u7528\u4f8b\u5417&#xff1f;<\/li>\n<li>\u5224\u5b9a\u901a\u8fc7\u7684\u6807\u51c6\u662f\u4e00\u4e2a\u503c\u3001\u4e00\u4e2a\u72b6\u6001&#xff0c;\u8fd8\u662f\u4e00\u53e5\u5f62\u5bb9\u8bcd&#xff1f;<\/li>\n<li>\u51fa\u73b0\u300c\u53cb\u597d\u300d\u300c\u7b80\u4fbf\u300d\u300c\u7a33\u5b9a\u300d\u300c\u9ad8\u6548\u300d\u4e86\u5417&#xff1f;\u51fa\u73b0\u5c31\u6539\u5199\u3002<\/li>\n<li>\u6bcf\u6761\u9700\u6c42\u90fd\u6709\u552f\u4e00\u7f16\u53f7\u5417&#xff1f;<\/li>\n<li>\u6bcf\u6761\u9700\u6c42\u6807\u4e86\u5fc5\u987b\u3001\u5e94\u8be5\u3001\u53ef\u4ee5\u5417&#xff1f;<\/li>\n<li>\u80fd\u5bf9\u5e94\u5230\u6d41\u7a0b\u6e05\u5355\u91cc\u7684\u54ea\u4e00\u6761&#xff1f;<\/li>\n<li>\u6d89\u53ca\u8bb0\u5f55\u7684&#xff0c;\u5199\u6e05\u4fdd\u5b58\u671f\u9650\u548c\u4fee\u6539\u6743\u9650\u4e86\u5417&#xff1f;<\/li>\n<li>\u6d89\u53ca\u63a5\u53e3\u7684&#xff0c;\u5199\u6e05\u534f\u8bae\u3001\u9891\u7387\u3001\u5931\u8d25\u5904\u7406\u4e86\u5417&#xff1f;<\/li>\n<li>\u6d89\u53ca\u8ba1\u7b97\u7684&#xff0c;\u5199\u6e05\u516c\u5f0f\u3001\u7cbe\u5ea6\u3001\u5f02\u5e38\u503c\u5904\u7406\u4e86\u5417&#xff1f;<\/li>\n<li>\u4f9b\u5e94\u5546\u63d0\u7684\u6bcf\u4e00\u6761\u504f\u79bb&#xff0c;\u80fd\u5bf9\u5e94\u5230\u67d0\u4e2a\u7f16\u53f7\u5417&#xff1f;<\/li>\n<h3>\u68c0\u67e5\u5b98\u4f1a\u600e\u4e48\u95ee<\/h3>\n<p>\u300c\u8fd9\u6761\u9700\u6c42\u600e\u4e48\u9a8c\u6536\u7684&#xff1f;\u300d<\/p>\n<p>\u7b54&#xff1a;\u62a5\u9700\u6c42\u7f16\u53f7&#xff0c;\u7ffb\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635&#xff08;RTM&#xff0c;Requirements Traceability Matrix&#xff09;\u6307\u5230\u5bf9\u5e94\u7528\u4f8b&#xff0c;\u8bf4\u51fa\u5224\u5b9a\u6761\u4ef6\u3002\u7b54\u300c\u6309\u4f9b\u5e94\u5546\u7684\u9a8c\u6536\u65b9\u6848\u505a\u7684\u300d&#xff0c;\u7b49\u4e8e\u627f\u8ba4 URS \u6ca1\u8d77\u4f5c\u7528\u3002<\/p>\n<p>\u300cURS \u662f\u4f60\u4eec\u5199\u7684&#xff0c;\u8fd8\u662f\u4f9b\u5e94\u5546\u5199\u7684&#xff1f;\u300d<\/p>\n<p>\u7b54&#xff1a;\u7ffb\u7248\u672c\u8bb0\u5f55&#xff0c;\u8d77\u8349\u4eba\u662f\u7532\u65b9\u4e1a\u52a1\u4e0e IT&#xff0c;\u6279\u51c6\u4eba\u662f QA&#xff0c;\u4f9b\u5e94\u5546\u53ea\u63d0\u610f\u89c1\u3002\u4f9b\u5e94\u5546\u4ee3\u5199\u3001\u7532\u65b9\u53ea\u7b7e\u5b57\u7684 URS&#xff0c;\u68c0\u67e5\u65f6\u57fa\u672c\u7ad9\u4e0d\u4f4f\u3002<\/p>\n<p>\u300c\u4e0a\u7ebf\u540e\u52a0\u7684\u8fd9\u4e2a\u529f\u80fd&#xff0c;\u5728 URS \u91cc\u5417&#xff1f;\u300d<\/p>\n<p>\u7b54&#xff1a;\u8d70\u53d8\u66f4\u63a7\u5236\u8bc4\u4f30\u540e\u5347\u7248 URS&#xff0c;\u540c\u6b65\u5347 RTM \u4e0e\u6d4b\u8bd5\u7528\u4f8b&#xff0c;\u7248\u672c\u53f7\u5199\u8fdb\u53d8\u66f4\u5355\u3002\u7b54\u300c\u53e3\u5934\u63d0\u7684&#xff0c;\u4f9b\u5e94\u5546\u76f4\u63a5\u505a\u4e86\u300d&#xff0c;\u8fd9\u4e00\u6761\u5c31\u843d\u6210\u7f3a\u9677\u3002<\/p>\n<h3>\u4e00\u53e5\u603b\u7ed3<\/h3>\n<p>URS \u7684\u7b2c\u4e00\u8bfb\u8005\u4e0d\u662f\u4f9b\u5e94\u5546&#xff0c;\u662f\u9a8c\u6536\u90a3\u5929\u62ff\u7740\u7528\u4f8b\u56de\u5934\u5bf9\u7684\u4eba\u3002<\/p>\n<p>\u4e0b\u4e00\u7bc7&#xff1a;\u7b2c 12 \u7bc7\u300a\u9700\u6c42\u8ffd\u6eaf\u77e9\u9635 RTM&#xff1a;\u4e3a\u4ec0\u4e48\u68c0\u67e5\u5b98\u5fc5\u770b\u8fd9\u5f20\u8868\u300b\u2014\u2014\u4e00\u5f20\u8868\u8bc1\u660e\u6bcf\u6761\u9700\u6c42\u90fd\u88ab\u6d4b\u8fc7&#xff0c;\u7f3a\u884c\u5c31\u662f\u7f3a\u8bc1\u3002<\/p>\n<h3>\u6cd5\u89c4\u4f9d\u636e<\/h3>\n<li>\u300a\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303&#xff08;2010 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\u9010\u6761\u6838\u5bf9\u539f\u59cb\u6570\u636e\u4e0e\u8bb0\u5f55\u662f\u5426\u5bf9\u5f97\u4e0a<\/p>\n<p>\u624b\u91cc\u6709\u8fd9\u7c7b\u6d3b\u513f\u5361\u7740&#xff0c;\u6216\u8005\u53ea\u662f\u60f3\u95ee\u95ee\u80fd\u4e0d\u80fd\u81ea\u52a8\u5316&#xff0c;\u90fd\u6b22\u8fce\u8bc4\u8bba\u533a\u804a&#xff0c;\u5148\u628a\u95ee\u9898\u8bf4\u6e05\u695a\u518d\u8c08\u600e\u4e48\u505a\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2018 \u5e74\u90a3\u5957 LIMS&#xff08;\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u7cfb\u7edf&#xff0c;Laboratory Information Management System&#xff09;\u9009\u578b&#xff0c;\u6211\u628a URS&#xff08;\u7528\u6237\u9700\u6c42\u8bf4\u660e&#xff0c;User Requirements 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