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id=\"%E7%A7%98%E8%AF%80%E4%B8%80%EF%BC%9A%E6%A0%87%E5%87%86%E5%8C%96_-_%E5%BB%BA%E7%AB%8B%E7%BB%9F%E4%B8%80%E7%9A%84%E2%80%9C%E5%BA%A6%E9%87%8F%E8%A1%A1%E2%80%9D%EF%BC%8C%E8%AE%A9%E5%AE%A1%E6%A0%B8%E6%9C%89%E7%AB%A0%E5%8F%AF%E5%BE%AA\"><\/span>\u79d8\u8bc0\u4e00\uff1a\u6807\u51c6\u5316 - \u5efa\u7acb\u7edf\u4e00\u7684\u201c\u5ea6\u91cf\u8861\u201d\uff0c\u8ba9\u5ba1\u6838\u6709\u7ae0\u53ef\u5faa<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u6807\u51c6\u5316\u662f\u6240\u6709\u6570\u636e\u5316\u7ba1\u7406\u7684\u57fa\u7840\u3002\u5982\u679c\u8f93\u5165\u7aef\u7684\u6570\u636e\u6807\u51c6\u4e0d\u4e00\uff0c\u540e\u7eed\u7684\u5206\u6790\u548c\u51b3\u7b56\u5c31\u65e0\u4ece\u8c08\u8d77\u3002<\/p>\n<ul>\n<li>\n<p><strong>\u6b65\u9aa41\uff1a\u7edf\u4e00\u5ba1\u6838\u6e05\u5355\u4e0e\u6807\u51c6<\/strong>\u5c06 SOP \u548c\u8d28\u91cf\u63a7\u5236\u8ba1\u5212\uff08Control Plan\uff09\u4e2d\u7684\u6838\u5fc3\u8981\u6c42\uff0c\u8f6c\u5316\u4e3a\u7ed3\u6784\u5316\u7684\u3001\u53ef\u6267\u884c\u7684\u5ba1\u6838\u68c0\u67e5\u9879\u3002\u4f8b\u5982\uff0c\u5c06\u201c\u68c0\u67e5\u626d\u77e9\u201d\u8fd9\u4e00\u9879\uff0c\u660e\u786e\u5b9a\u4e49\u4e3a\u201c\u4f7f\u7528A\u578b\u53f7\u626d\u77e9\u6273\u624b\uff0c\u5bf9M6\u87ba\u4e1d\u8fdb\u884c\u68c0\u67e5\uff0c\u626d\u77e9\u503c\u5e94\u5728 5.0\u00b10.5 N\u00b7m \u8303\u56f4\u5185\u201d\u3002\u540c\u65f6\uff0c\u5e94\u80fd\u9488\u5bf9\u4e0d\u540c\u4ea7\u7ebf\u3001\u5de5\u5e8f\u3001\u4ea7\u54c1\uff0c\u5efa\u7acb\u52a8\u6001\u7684\u5ba1\u6838\u6e05\u5355\u6a21\u677f\u5e93\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u6b65\u9aa42\uff1a\u89c4\u8303\u4e0d\u5408\u683c\u54c1\u5904\u7406\u6d41\u7a0b<\/strong>\u6e05\u6670\u5730\u5b9a\u4e49\u4e0d\u5408\u683c\u54c1\u7684\u7b49\u7ea7\uff08\u5982\u8f7b\u5fae\u3001\u4e3b\u8981\u3001\u4e25\u91cd\uff09\uff0c\u5e76\u5bf9\u6bcf\u79cd\u7f3a\u9677\u63d0\u4f9b\u6807\u51c6\u7684\u63cf\u8ff0\u672f\u8bed\u548c\u56fe\u4f8b\u3002\u540c\u65f6\uff0c\u56fa\u5316\u4ece\u53d1\u73b0\u3001\u9694\u79bb\u3001\u8bc4\u5ba1\u5230\u5904\u7f6e\u7684\u5168\u8fc7\u7a0b SOP\uff0c\u660e\u786e\u5404\u73af\u8282\u7684\u8d23\u4efb\u4eba\u4e0e\u5904\u7406\u65f6\u9650\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u6b65\u9aa43\uff1a\u8bbe\u5b9a\u6570\u636e\u91c7\u96c6\u89c4\u5219<\/strong>\u5728\u5ba1\u6838\u6e05\u5355\u4e2d\uff0c\u5f3a\u5236\u89c4\u5b9a\u5173\u952e\u5de5\u5e8f\u5fc5\u987b\u91c7\u96c6\u7684\u6570\u636e\u7c7b\u578b\u3002\u4f8b\u5982\uff0c\u6e29\u5ea6\u53c2\u6570\u5fc5\u987b\u662f\u6570\u503c\uff0c\u5916\u89c2\u68c0\u67e5\u5fc5\u987b\u9644\u5e26\u73b0\u573a\u7167\u7247\uff0c\u7269\u6599\u6279\u6b21\u5fc5\u987b\u901a\u8fc7\u626b\u7801\u5f55\u5165\u3002\u8fd9\u786e\u4fdd\u4e86\u6240\u6709\u5ba1\u6838\u5458\u90fd\u4f7f\u7528\u7edf\u4e00\u7684\u201c\u8bed\u8a00\u201d\u8fdb\u884c\u8bb0\u5f55\u3002<\/p>\n<\/li>\n<\/ul>\n<p><strong>\u672c\u8282\u5c0f\u7ed3\uff1a\u6807\u51c6\u5316\u662f\u5b9e\u73b0\u6570\u636e\u4e00\u81f4\u6027\u7684\u524d\u63d0\uff0c\u662f\u9ad8\u6548\u7ba1\u7406\u7684\u5730\u57fa\u3002<\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E7%A7%98%E8%AF%80%E4%BA%8C%EF%BC%9A%E6%95%B0%E5%AD%97%E5%8C%96_-_%E6%89%93%E9%80%9A%E6%95%B0%E6%8D%AE%E7%9A%84%E2%80%9C%E9%AB%98%E9%80%9F%E8%B7%AF%E2%80%9D%EF%BC%8C%E8%AE%A9%E8%BF%87%E7%A8%8B%E5%AE%9E%E6%97%B6%E5%8F%AF%E8%A7%81\"><\/span>\u79d8\u8bc0\u4e8c\uff1a\u6570\u5b57\u5316 - \u6253\u901a\u6570\u636e\u7684\u201c\u9ad8\u901f\u8def\u201d\uff0c\u8ba9\u8fc7\u7a0b\u5b9e\u65f6\u53ef\u89c1<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u5f53\u6807\u51c6\u5efa\u7acb\u540e\uff0c\u6570\u5b57\u5316\u662f\u6253\u901a\u6570\u636e\u58c1\u5792\u3001\u5b9e\u73b0\u4fe1\u606f\u9ad8\u901f\u6d41\u8f6c\u7684\u552f\u4e00\u624b\u6bb5\u3002<\/p>\n<ul>\n<li>\n<p><strong>\u5b9e\u8df5\u8def\u5f841\uff1a\u5ba1\u6838\u6267\u884c\u79fb\u52a8\u5316<\/strong>\u7528\u624b\u673a\u6216\u5e73\u677f\u7535\u8111 App \u66ff\u4ee3\u7eb8\u8d28\u8868\u5355\u3002\u4e00\u7ebf\u5ba1\u6838\u5458\u53ef\u4ee5\u968f\u65f6\u968f\u5730\u63a5\u6536\u4efb\u52a1\u3001\u6267\u884c\u68c0\u67e5\u3002\u9047\u5230\u95ee\u9898\u65f6\uff0c\u53ef\u4ee5\u76f4\u63a5\u901a\u8fc7\u8bbe\u5907\u62cd\u7167\u3001\u5f55\u50cf\uff0c\u8ba9\u6587\u5b57\u63cf\u8ff0\u4e0e\u73b0\u573a\u8bc1\u636e\u76f4\u63a5\u7ed1\u5b9a\uff0c\u4fe1\u606f\u66f4\u52a0\u76f4\u89c2\u51c6\u786e\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u5b9e\u8df5\u8def\u5f842\uff1a\u6570\u636e\u91c7\u96c6\u81ea\u52a8\u5316<\/strong>\u5bf9\u4e8e\u80fd\u591f\u81ea\u52a8\u5316\u7684\u73af\u8282\uff0c\u5e94\u5c3d\u53ef\u80fd\u51cf\u5c11\u4eba\u5de5\u5e72\u9884\u3002\u4f8b\u5982\uff0c\u901a\u8fc7\u626b\u63cf\u5de5\u5355\u6216\u4ea7\u54c1\u4e0a\u7684\u6761\u7801\uff0c\u81ea\u52a8\u5173\u8054\u751f\u4ea7\u4fe1\u606f\uff1b\u901a\u8fc7\u5bf9\u63a5\u8bbe\u5907\u7269\u8054\u7f51\uff08IoT\uff09\u63a5\u53e3\uff0c\u81ea\u52a8\u83b7\u53d6\u5173\u952e\u7684\u5de5\u827a\u53c2\u6570\uff08\u5982\u6e29\u5ea6\u3001\u538b\u529b\u3001\u901f\u5ea6\uff09\u3002\u6570\u636e\u5b9e\u65f6\u4e0a\u4f20\u81f3\u4e91\u7aef\uff0c\u5f7b\u5e95\u675c\u7edd\u4e86\u4e8c\u6b21\u5f55\u5165\u7684\u9519\u8bef\u4e0e\u5ef6\u8fdf\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u5b9e\u8df5\u8def\u5f843\uff1a\u4fe1\u606f\u534f\u540c\u5728\u7ebf\u5316<\/strong>\u5f53\u4e0d\u5408\u683c\u54c1\u5728\u73b0\u573a\u88ab\u8bb0\u5f55\u65f6\uff0c\u7cfb\u7edf\u53ef\u4ee5\u6839\u636e\u9884\u8bbe\u89c4\u5219\uff0c\u81ea\u52a8\u901a\u8fc7 App \u63a8\u9001\u3001\u77ed\u4fe1\u6216\u90ae\u4ef6\u7b49\u65b9\u5f0f\uff0c\u901a\u77e5\u76f8\u5173\u8d23\u4efb\u4eba\uff08\u5982\u73ed\u7ec4\u957f\u3001\u5de5\u7a0b\u5e08\u3001\u7ef4\u4fee\u4eba\u5458\uff09\u7acb\u5373\u542f\u52a8\u7ea0\u6b63\u6216\u5904\u7f6e\u6d41\u7a0b\u3002\u540c\u65f6\uff0c\u8d28\u91cf\u8ffd\u6eaf\u62a5\u544a\u53ef\u4ee5\u4e00\u952e\u751f\u6210\uff0c\u5728\u51e0\u79d2\u949f\u5185\u5c31\u6e05\u6670\u5448\u73b0\u4ece\u6210\u54c1\u5230\u539f\u6599\u3001\u5de5\u5e8f\u3001\u8bbe\u5907\u3001\u4eba\u5458\u7684\u5168\u94fe\u6761\u4fe1\u606f\u3002<\/p>\n<\/li>\n<li>\n<p><strong>\u5de5\u5177\u8d4b\u80fd\u6848\u4f8b\uff1a<\/strong>\u4ee5\u300c\u652f\u9053\u300d\u8fd9\u7c7b\u6570\u5b57\u5316\u8d28\u91cf\u7ba1\u7406\u7cfb\u7edf\u4e3a\u4f8b\uff0c\u4f01\u4e1a\u53ef\u4ee5\u5c06\u6807\u51c6\u5316\u7684\u5ba1\u6838\u6e05\u5355\u6a21\u677f\u90e8\u7f72\u5230\u79fb\u52a8\u7aef App\u3002\u4e00\u7ebf\u4eba\u5458\u5728\u73b0\u573a\u5b8c\u6210\u6570\u636e\u91c7\u96c6\u540e\uff0c\u6570\u636e\u4f1a\u5b9e\u65f6\u540c\u6b65\u81f3\u4e91\u7aef\uff0c\u4e00\u65e6\u53d1\u73b0\u5f02\u5e38\uff0c\u7cfb\u7edf\u4fbf\u80fd\u81ea\u52a8\u89e6\u53d1\u9884\u8bbe\u7684\u5ba1\u6279\u6216\u901a\u77e5\u6d41\u7a0b\uff0c\u5c06\u4fe1\u606f\u6d41\u8f6c\u65f6\u95f4\u4ece\u5c0f\u65f6\u7ea7\u538b\u7f29\u5230\u5206\u949f\u7ea7\u3002<\/p>\n<\/li>\n<\/ul>\n<p><strong>\u672c\u8282\u5c0f\u7ed3\uff1a\u6570\u5b57\u5316\u6253\u901a\u4e86\u6570\u636e\u5b64\u5c9b\uff0c\u8ba9\u539f\u672c\u770b\u4e0d\u89c1\u7684\u751f\u4ea7\u8fc7\u7a0b\u53d8\u5f97\u900f\u660e\u3002<\/strong><\/p>\n<h3><span class=\"ez-toc-section\" id=\"%E7%A7%98%E8%AF%80%E4%B8%89%EF%BC%9A%E6%99%BA%E8%83%BD%E5%8C%96_-_%E5%AE%89%E8%A3%85%E5%86%B3%E7%AD%96%E7%9A%84%E2%80%9C%E6%99%BA%E6%85%A7%E8%84%91%E2%80%9D%EF%BC%8C%E8%AE%A9%E6%94%B9%E8%BF%9B%E6%9C%89%E6%8D%AE%E5%8F%AF%E4%BE%9D\"><\/span>\u79d8\u8bc0\u4e09\uff1a\u667a\u80fd\u5316 - 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CAPA \u4efb\u52a1\uff0c\u6307\u6d3e\u7ed9\u8d23\u4efb\u4eba\uff0c\u660e\u786e\u5b8c\u6210\u65f6\u9650\u548c\u9a8c\u8bc1\u6807\u51c6\u3002\u7cfb\u7edf\u4f1a\u81ea\u52a8\u8ffd\u8e2a\u6539\u8fdb\u4efb\u52a1\u7684\u6267\u884c\u8fdb\u5ea6\u548c\u6548\u679c\u9a8c\u8bc1\uff0c\u76f4\u81f3\u95ee\u9898\u786e\u8ba4\u5173\u95ed\uff0c\u5e76\u5c06\u6210\u529f\u7684\u89e3\u51b3\u65b9\u6848\u6c89\u6dc0\u5230\u77e5\u8bc6\u5e93\u4e2d\uff0c\u9632\u6b62\u672a\u6765\u518d\u72af\u3002<\/p>\n<\/li>\n<\/ul>\n<p><strong>\u672c\u8282\u5c0f\u7ed3\uff1a\u667a\u80fd\u5316\u8ba9\u6570\u636e\u4ece\u201c\u8bb0\u5f55\u201d\u53d8\u4e3a\u201c\u8d44\u4ea7\u201d\uff0c\u9a71\u52a8\u7ba1\u7406\u51b3\u7b56\u4e0e\u6301\u7eed\u6539\u8fdb\u3002<\/strong><\/p>\n<hr>\n<h2><span class=\"ez-toc-section\" 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