{"id":59682,"date":"2018-12-03T01:00:00","date_gmt":"2018-12-07T02:47:54","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/38c00434dd\/"},"modified":"2018-12-07T10:48:08","modified_gmt":"2018-12-07T02:48:08","slug":"38c00434dd","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/59682\/","title":{"rendered":"\u8f6c\u8f7d&#8212;WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<p style=\"text-align: center;\"><img       src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/3-1544150875.jpeg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><\/p>\n<p><span style=\"font: 16px\/27px \u5fae\u8f6f\u96c5\u9ed1;margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;widows: 1;font-size-adjust: none;font-stretch: normal;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;overflow-wrap: break-word;\"><strong style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);line-height: 27px;letter-spacing: 0.54px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word;\"><span style=\"margin: 0px;padding: 0px;font-family: \u5fae\u8f6f\u96c5\u9ed1, sans-serif;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word;\"><strong style=\"margin: 0px;padding: 0px;letter-spacing: 0.54px;font-family: \u5fae\u8f6f\u96c5\u9ed1;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;overflow-wrap: break-word;\">\u258d<\/strong><\/span><\/strong><\/span><span style=\"font: 16px\/27px \u5fae\u8f6f\u96c5\u9ed1;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;word-spacing: 0px;float: none;display: inline !important;white-space: normal;widows: 1;font-size-adjust: none;font-stretch: normal;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">\u6765\u6e90\uff1aGMP\u529e\u516c\u5ba4&nbsp;&nbsp;&nbsp;\u58f0\u660e\uff1a\u8f6c\u8f7d\u53ea\u662f\u4e3a\u4e86\u5b66\u4e60\uff0c\u6d89\u53ca\u4fb5\u6743\uff0c\u7acb\u5373\u5220\u9664\u3002<\/span><\/p>\n<p><span style=\"font: 16px\/27px \u5fae\u8f6f\u96c5\u9ed1;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;word-spacing: 0px;float: none;display: inline !important;white-space: normal;widows: 1;font-size-adjust: none;font-stretch: normal;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br  \/><\/span><\/p>\n<p><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/1-1544150875.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/5-1544150876.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/8-1544150876.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150877.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/5-1544150878.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/5-1544150879.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/10-1544150879.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150880.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150880-1.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/8-1544150881.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150881.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/1-1544150882.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/9-1544150883.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/0-1544150883.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150884.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/0-1544150885.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/0-1544150885-1.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/0-1544150886.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150887.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544150887-1.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><img     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/7-1544150888.jpg\" alt=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\" title=\"\u8f6c\u8f7d---WHO\u300a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u9a8c\u8bc1\u6307\u5357\u300b\u5f81\u6c42\u610f\u89c1\u7a3f\uff082018\u5e74\uff09\"  \/><\/p>\n<ul class=\"list-paddingleft-2\" style=\"margin-right: 0px;margin-left: 0px;\">\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9002\u5f53\u7a0b\u5ea6\u7684\u6311\u6218\u6027\u6d4b\u8bd5\uff08\u5982\u8fb9\u754c\uff0c\u8303\u56f4\uff0c\u9650\u5236\uff0c\u65e0\u6548\u8f93\u5165\u6d4b\u8bd5\uff09\uff0c\u4ee5\u786e\u8ba4\u7cfb\u7edf\u53ef\u4ee5\u6b63\u786e\u5730\u5904\u7406\u4e0d\u6b63\u786e\u7684\u8f93\u5165\u6216\u4e0d\u6b63\u786e\u7684\u4f7f\u7528\u3002<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">verification that alarms are raised based upon alarm conditions;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u786e\u8ba4\u5728\u8b66\u62a5\u6761\u4ef6\u4e0b\u80fd\u89e6\u53d1\u62a5\u8b66<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">flags are raised to signal invalid or altered data.<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u65e0\u6548\u4fe1\u53f7\u6216\u88ab\u4fee\u6539\u7684\u6570\u636e\u53ef\u4ee5\u88ab\u6807\u8bb0<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">12. &nbsp;STANDARD OPERATING PROCEDURES AND TRAINING<\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\u548c\u57f9\u8bad<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">12.1. Prior to the conduct of the performance qualification (PQ) and user acceptance testing (UAT), and prior to the release of the computerized system, there should be adequate written procedures and documents and training programmes created defining system use and control. These &nbsp;may include &nbsp;vendor-supplied &nbsp;user &nbsp;manuals &nbsp;as &nbsp;well &nbsp;as &nbsp;SOPs &nbsp;and &nbsp;training &nbsp;programs developed in-house.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u6027\u80fd\u786e\u8ba4\uff08PQ\uff09\u548c\u7528\u6237\u9a8c\u6536\u6d4b\u8bd5\uff08UAT\uff09\u5f00\u59cb\u524d\uff0c\u4ee5\u53ca\u5728\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u653e\u884c\u4e4b\u524d\uff0c\u5e94\u5efa\u7acb\u5145\u5206\u7684\u5b9a\u4e49\u7cfb\u7edf\u4f7f\u7528\u548c\u63a7\u5236\u7684\u4e66\u9762\u89c4\u7a0b\u548c\u6587\u4ef6\u4ee5\u53ca\u57f9\u8bad\u7a0b\u5e8f\u3002\u5305\u62ec\u4f9b\u5e94\u5546\u63d0\u4f9b\u7684\u7528\u6237\u624b\u518c\u4ee5\u53ca\u4f01\u4e1a SOP \u548c\u57f9\u8bad\u7a0b\u5e8f\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">12.2. Procedures &nbsp;and &nbsp;training &nbsp;programs &nbsp;that &nbsp;should &nbsp;be &nbsp;developed &nbsp;include, &nbsp;but &nbsp;are &nbsp;not necessarily limited to:<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u8d77\u8349\u7684\u89c4\u7a0b\u548c\u57f9\u8bad\u7a0b\u5e8f\u5305\u62ec\uff0c\u4f46\u4e0d\u9650\u4e8e\uff1a<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">system use procedures that address:&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u4f7f\u7528\u89c4\u7a0b\uff0c\u660e\u786e\uff1a<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<ul class=\"list-paddingleft-2\" style=\"margin-right: 0px;margin-left: 0px;\">\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">routine operation and use of the system in the intended business process(es),&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u5728\u65e2\u5b9a\u4e1a\u52a1\u6d41\u7a0b\u5185\u7684\u65e5\u5e38\u64cd\u4f5c\u548c\u4f7f\u7528<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">review of the electronic data and associated metadata (such as audit trails) and how the source electronic records will be reconciled with printouts, if any,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7535\u5b50\u6570\u636e\u53ca\u76f8\u5173\u5143\u6570\u636e\uff08\u5982\u5ba1\u8ba1\u8ffd\u8e2a\uff09\u7684\u5ba1\u6838\uff0c\u4ee5\u53ca\u5982\u6253\u5370\uff0c\u600e\u6837\u5bf9\u6bd4\u539f\u59cb\u7535\u5b50\u8bb0\u5f55\u548c\u6253\u5370\u7684\u7eb8\u8d28\u8bb0\u5f55<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">mechanisms for signing electronic data,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7b7e\u7f72\u7535\u5b50\u6570\u636e\u7684\u673a\u5236<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">system training requirements prior to being granted system access;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5728\u6388\u4e88\u7cfb\u7edf\u8bbf\u95ee\u6743\u9650\u4e4b\u524d\u7684\u7cfb\u7edf\u57f9\u8bad\u8981\u6c42<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">system administration procedures that address:<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u7ba1\u7406\u89c4\u7a0b\uff0c\u660e\u786e\uff1a<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<ul class=\"list-paddingleft-2\" style=\"margin-right: 0px;margin-left: 0px;\">\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">granting and disabling user access and maintaining security controls,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7528\u6237\u8bbf\u95ee\u548c\u7ef4\u62a4\u5b89\u5168\u63a7\u5236\u7684\u6388\u6743\u548c\u7981\u7528<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">backup\/restore,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5907\u4efd\/\u6062\u590d<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">archival\/retrieval,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5f52\u6863\/\u68c0\u7d22<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">disaster recovery and business continuity,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u707e\u96be\u6062\u590d\u548c\u4e1a\u52a1\u8fde\u7eed\u6027<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">change management,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53d8\u66f4\u7ba1\u7406<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">incident and problem management,&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e8b\u4ef6\u548c\u95ee\u9898\u7ba1\u7406<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">system maintenance.&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u7ef4\u62a4<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">13. &nbsp;PERFORMANCE QUALIFICATION AND USER ACCEPTANCE TESTING<\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6027\u80fd\u786e\u8ba4\u548c\u7528\u6237\u9a8c\u6536\u6d4b\u8bd5<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.1. PQ, that includes UAT, should be conducted to verify the intended system use and administration defined in the URS and design qualification (DQ), or equivalent document.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u6267\u884c PQ\uff0c\u5305\u62ec UAT\uff0c\u4ee5\u786e\u8ba4 URS \u548c\u8bbe\u8ba1\u786e\u8ba4\uff08DQ\uff09\uff0c\u6216\u5176\u5b83\u540c\u7b49\u6587\u4ef6\u4e2d\u89c4\u5b9a\u7684\u7cfb\u7edf\u9884\u671f\u7528\u9014\u548c\u7ba1\u7406\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.2. The PQ should be conducted in the live environment or in a test environment that is equivalent to the live environment in terms of overall software and hardware configuration.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PQ \u5e94\u5728\u4f7f\u7528\u73af\u5883\u4e0b\uff0c\u6216\u7b49\u540c\u4e8e\u4f7f\u7528\u73af\u5883\u7684\u6d4b\u8bd5\u73af\u5883\uff08\u5305\u62ec\u6574\u4f53\u8f6f\u4ef6\u548c\u786c\u4ef6\u914d\u7f6e\u65b9\u9762\uff09\u4e0b\u6267\u884c\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.3. PQtestingshouldalsoinclude,asapplicable,anappropriatedegreeof stress\/load\/volume testing based upon the anticipated system use and performance requirements in the production environment.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">PQ \u6d4b\u8bd5\u5e94\u5305\u62ec\uff0c\u5982\u9002\u7528\uff0c\u6839\u636e\u7cfb\u7edf\u9884\u671f\u7528\u9014\u548c\u5728\u4f7f\u7528\u73af\u5883\u4e0b\u7684\u6027\u80fd\u8981\u6c42\u8fdb\u884c\u9002\u5f53\u7684\u538b\u529b\/\u8d1f\u8f7d\/\u5bb9\u91cf\u6d4b\u8bd5\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.4. In addition, an appropriate degree of end-to-end or regression testing of the system should &nbsp;be &nbsp;conducted &nbsp;to &nbsp;verify the &nbsp;system &nbsp;performs &nbsp;reliably when &nbsp;system &nbsp;components &nbsp;are integrated in the fully-configured system deployed in the production environment.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53e6\u5916\uff0c\u5e94\u6267\u884c\u9002\u5f53\u7a0b\u5ea6\u7684\u7cfb\u7edf\u7684\u7aef\u5230\u7aef\u6216\u56de\u5f52\u6d4b\u8bd5\uff0c\u4ee5\u786e\u8ba4\u7cfb\u7edf\u7ec4\u4ef6\u5728\u4f7f\u7528\u73af\u5883\u96c6\u6210\u4e3a\u4e00\u4e2a\u5b8c\u5168\u914d\u7f6e\u7684\u7cfb\u7edf\u540e\uff0c\u7cfb\u7edf\u6027\u80fd\u53ef\u9760\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.5. UAT should be conducted by system users to verify the adequacy of system, use of SOPs and training programs. The UAT should include verification of the ability to generate and process only valid data within the computerized system, including the ability to efficiently review electronic data and metadata, such as audit trails.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u7528\u6237\u5e94\u8fdb\u884c UAT \u6d4b\u8bd5\u4ee5\u786e\u8ba4\u7cfb\u7edf\u3001SOP \u4f7f\u7528\u548c\u57f9\u8bad\u9879\u76ee\u7684\u5145\u5206\u6027\u3002UAT \u5e94\u5305\u62ec\uff0c\u786e\u8ba4\u5728\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u5185\uff0c\u751f\u6210\u548c\u5904\u7406\u6570\u636e\u6709\u6548\u7684\u80fd\u529b\uff0c\u5305\u62ec\u80fd\u591f\u6709\u6548\u5730\u5ba1\u6838\u7535\u5b50\u6570\u636e\u548c\u5143\u6570\u636e\u7684\u80fd\u529b\uff0c\u5982\u5ba1\u8ba1\u8ffd\u8e2a\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">Legacy systems<\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9057\u7559\u7cfb\u7edf<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.6. The continued use of a legacy system should be justified by demonstrating the system continues to be relevant to the GMP process being supported and by ensuring adequate validation of the system has been performed.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9057\u7559\u7cfb\u7edf\u7684\u7ee7\u7eed\u4f7f\u7528\u5e94\u7ecf\u8fc7\u8bba\u8bc1\uff0c\u8bc1\u660e\u7cfb\u7edf\u7ee7\u7eed\u4e0e\u6240\u652f\u6301\u7684 GMP \u6d41\u7a0b\u76f8\u5173\uff0c\u5e76\u786e\u4fdd\u5b9e\u65bd\u4e86\u5145\u5206\u7684\u7cfb\u7edf\u9a8c\u8bc1\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.7. The validation approach to be taken should aim at providing data and information to support the retrospective documentation of the system as well as requalification evidence.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6240\u91c7\u53d6\u7684\u9a8c\u8bc1\u65b9\u6cd5\u5e94\u80fd\u63d0\u4f9b\u7528\u4e8e\u652f\u6301\u7cfb\u7edf\u56de\u987e\u6027\u6587\u4ef6\u4ee5\u53ca\u518d\u786e\u8ba4\u8bc1\u636e\u7684\u6570\u636e\u548c\u4fe1\u606f\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.8. A risk assessment should be undertaken to determine the criticality of the system to the process or operation being supported and a gap analysis should identify the level of completeness of existing qualification documentation (e.g. URS, IQ\/OQ\/PQ, SOPs) and state of system control, operation and maintenance.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u8fdb\u884c\u98ce\u9669\u8bc4\u4f30\uff0c\u786e\u5b9a\u7cfb\u7edf\u5bf9\u4e8e\u5176\u6240\u652f\u6301\u7684\u6d41\u7a0b\u6216\u64cd\u4f5c\u7684\u5173\u952e\u6027\uff0c\u5e76\u8fdb\u884c\u5dee\u8ddd\u5206\u6790\u8bc6\u522b\u73b0\u6709\u786e\u8ba4\u6587\u4ef6\uff08\u5982 URS,IQ\/OQ\/PQ,SOP\uff09\u7684\u5b8c\u6574\u7a0b\u5ea6\uff0c\u4ee5\u53ca\u7cfb\u7edf\u63a7\u5236\u3001\u64cd\u4f5c\u548c\u7ef4\u62a4\u7684\u8bf4\u660e\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.9. For legacy systems, because of their age and unique characteristics, the system development documentation and records appropriate for validation may not be available. Nevertheless, the strategy should be consistent with validation principles where assurance is established, based on compilation and formal review of the history of use, maintenance, error report and change control system records. These activities should be based on documented URS. If historical data do not encompass the current range of operating parameters, or if there have been significant changes between past and current practices, then retrospective data would not of itself support validation of the current system.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5bf9\u4e8e\u9057\u7559\u7cfb\u7edf\uff0c\u7531\u4e8e\u5176\u5e74\u9650\u548c\u72ec\u7279\u7684\u7279\u6027\uff0c\u53ef\u80fd\u4e0d\u5177\u5907\u9002\u7528\u4e8e\u9a8c\u8bc1\u7684\u5f00\u53d1\u6587\u4ef6\u548c\u8bb0\u5f55\u3002\u7136\u800c\uff0c\u9a8c\u8bc1\u7b56\u7565\u5e94\u5728\u57fa\u4e8e\u7cfb\u7edf\u5386\u53f2\u4f7f\u7528\u3001\u7ef4\u62a4\u3001\u9519\u8bef\u62a5\u544a\u548c\u53d8\u66f4\u63a7\u5236\u7cfb\u7edf\u8bb0\u5f55\u7684\u68b3\u7406\u548c\u6b63\u5f0f\u5ba1\u6838\uff0c\u4e0e\u8d28\u91cf\u4fdd\u8bc1\u9a8c\u8bc1\u539f\u5219\u4e00\u81f4\u3002\u8fd9\u4e9b\u6d3b\u52a8\u5e94\u57fa\u4e8e\u4e66\u9762\u7684 URS\u3002\u5982\u679c\u5386\u53f2\u6570\u636e\u4e0d\u80fd\u591f\u8986\u76d6\u8fd0\u884c\u53c2\u6570\u7684\u73b0\u884c\u8303\u56f4\uff0c\u6216\u8005\u8fc7\u53bb\u548c\u73b0\u884c\u7684\u72b6\u6001\u4e4b\u95f4\u66fe\u6709\u8fc7\u91cd\u5927\u53d8\u66f4\u7684\uff0c\u90a3\u4e48\u56de\u987e\u6027\u6570\u636e\u4e0d\u80fd\u7528\u4e8e\u652f\u6301\u73b0\u884c\u7cfb\u7edf\u7684\u9a8c\u8bc1\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.10. The validation exercise should demonstrate that user requirements and system description have been appropriately established as well as provide evidence that the system has been qualified and accepted and that GXP requirements are met.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9a8c\u8bc1\u6d3b\u52a8\u5e94\u8bc1\u660e\u5df2\u6070\u5f53\u5730\u5236\u5b9a\u7528\u6237\u9700\u6c42\u548c\u7cfb\u7edf\u63cf\u8ff0\uff0c\u5e76\u63d0\u4f9b\u7cfb\u7edf\u7ecf\u786e\u8ba4\u548c\u63a5\u53d7\uff0c\u7b26\u5408 GXP \u8981\u6c42\u7684\u8bc1\u636e\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.11. System retirement should be considered as a system life-cycle phase. It should be planned, risk-based and documented. If migration or archiving of GMP-relevant data (4) is necessary, the process must be documented.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u9000\u5f79\u5e94\u4f5c\u4e3a\u7cfb\u7edf\u751f\u547d\u5468\u671f\u7684\u4e00\u4e2a\u9636\u6bb5\u8fdb\u884c\u8003\u5bdf\u3002\u7cfb\u7edf\u9000\u5f79\u5e94\u6709\u8ba1\u5212\uff0c\u57fa\u4e8e\u98ce\u9669\u548c\u4e66\u9762\u5316\u3002\u5982\u679c\u9700\u8981\u8fc1\u79fb\u6216\u5f52\u6863 GMP \u76f8\u5173\u6570\u636e\uff0c\u90a3\u4e48\u8be5\u8fc7\u7a0b\u5e94\u88ab\u8bb0\u5f55\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.12. Where electronic data are transferred from one system to another it should be demonstrated that data are not altered during the migration process. Conversion of data to a different format should be considered as data migration. Where data are transferred to another medium, data must be verified as an exact copy prior to any destruction of the original data.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5982\u679c\u7535\u5b50\u6570\u636e\u7531\u4e00\u4e2a\u7cfb\u7edf\u8f6c\u79fb\u5230\u53e6\u4e00\u4e2a\uff0c\u90a3\u4e48\u5e94\u8bc1\u660e\u6570\u636e\u5728\u8fc1\u79fb\u8fc7\u7a0b\u4e2d\u6ca1\u6709\u88ab\u6539\u53d8\u3002\u5c06\u6570\u636e\u8f6c\u6362\u4e3a\u4e0d\u540c\u683c\u5f0f\u5e94\u88ab\u89c6\u4e3a\u6570\u636e\u8fc1\u79fb\u3002\u5f53\u6570\u636e\u8f6c\u79fb\u5230\u53e6\u4e00\u4e2a\u4ecb\u8d28\u4e2d\uff0c\u5728\u9500\u6bc1\u539f\u59cb\u6570\u636e\u4e4b\u524d\uff0c\u5fc5\u987b\u786e\u8ba4\u8f6c\u79fb\u540e\u7684\u6570\u636e\u4e3a\u771f\u5b9e\u526f\u672c\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">13.13. Data migration efforts may vary greatly in complexity and measures to ensure appropriate transfer of data should be commensurate to identified risks. Migrated data should remain usable and should retain its content and meaning. The value and\/or meaning of and links between a system audit trail and electronic signatures should be ensured in a migration process.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6570\u636e\u8fc1\u79fb\u7684\u96be\u6613\u7a0b\u5ea6\u6839\u636e\u7cfb\u7edf\u590d\u6742\u6027\u800c\u5927\u4e0d\u76f8\u540c\u3002\u7528\u4e8e\u4fdd\u8bc1\u6570\u636e\u6b63\u786e\u8f6c\u79fb\u7684\u63aa\u65bd\u5e94\u4e0e\u6240\u8bc6\u522b\u7684\u98ce\u9669\u76f8\u5339\u914d\u3002\u8fc1\u79fb\u540e\u7684\u6570\u636e\u5e94\u4fdd\u6301\u5176\u53ef\u7528\u6027\uff0c\u5e76\u4fdd\u7559\u5176\u5185\u5bb9\u548c\u542b\u4e49\u3002\u8fc1\u79fb\u8fc7\u7a0b\u5e94\u4fdd\u8bc1\u7cfb\u7edf\u5ba1\u8ba1\u8ffd\u8e2a\u548c\u7535\u5b50\u7b7e\u540d\u4e0e\u539f\u6570\u503c\u548c\/\u6216\u542b\u4e49\u4e4b\u95f4\u7684\u94fe\u63a5\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">14. &nbsp;SYSTEM OPERATION AND MAINTENANCE<\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u64cd\u4f5c\u548c\u7ef4\u62a4<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">Security and access control<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5b89\u5168\u548c\u8bbf\u95ee\u63a7\u5236<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.1. Manufacturers should have systems and procedures in place to ensure security of data integrity and access control to computerized systems.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u751f\u4ea7\u5546\u5e94\u5177\u5907\u7cfb\u7edf\u548c\u7a0b\u5e8f\uff0c\u4fdd\u8bc1\u5b8c\u6574\u6570\u636e\u7684\u5b89\u5168\u6027\u548c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u8bbf\u95ee\u63a7\u5236\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.2. Suitable &nbsp;security &nbsp;measures &nbsp;should &nbsp;be &nbsp;in &nbsp;place &nbsp;to &nbsp;prevent &nbsp;unauthorized &nbsp;entry &nbsp;or manipulation or deletion of data through both the application software as well as in operating system environments in which data may be stored or transmitted. Data should be entered or amended only by persons authorized to do so.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u5236\u5b9a\u9002\u5f53\u7684\u63a7\u5236\u63aa\u65bd\u9632\u6b62\u5bf9\u6570\u636e\u672a\u7ecf\u6388\u6743\u7684\u8fdb\u5165\u6216\u7be1\u6539\u6216\u5220\u9664\uff0c\u4e0d\u7ba1\u662f\u901a\u8fc7\u8f6f\u4ef6\u672c\u8eab\u8fd8\u662f\u50a8\u5b58\u6216\u4f20\u8f93\u6570\u636e\u7684\u64cd\u4f5c\u7cfb\u7edf\u3002\u6570\u636e\u53ea\u80fd\u7531\u6388\u6743\u4eba\u5458\u8f93\u5165\u6216\u4fee\u6b63\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.3. The &nbsp;activity &nbsp;of &nbsp;entering &nbsp;data, &nbsp;changing &nbsp;or &nbsp;amending &nbsp;incorrect &nbsp;entries &nbsp;and &nbsp;creating backups should be done in accordance with SOPs.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u8f93\u5165\u6570\u636e\u3001\u6539\u53d8\u6216\u4fee\u6539\u9519\u8bef\u8f93\u5165\uff0c\u4ee5\u53ca\u521b\u5efa\u5907\u4efd\u7b49\u6d3b\u52a8\u5e94\u6309\u7167 SOP \u8fdb\u884c\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.4. Security should extend to devices used to store programs. Access to these devices should be controlled.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5b89\u5168\u63aa\u65bd\u5e94\u5ef6\u4f38\u81f3\u50a8\u5b58\u7a0b\u5e8f\u7684\u8bbe\u5907\u3002\u5e94\u63a7\u5236\u5bf9\u8fd9\u4e9b\u8bbe\u5907\u7684\u8bbf\u95ee\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.5. Procedures for review of audit trails and when necessary metadata should define the frequency, roles and responsibilities, and nature of these reviews.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5ba1\u8ba1\u8ffd\u8e2a\u5ba1\u6838\u548c\u9002\u7528\u60c5\u5f62\u4e0b\u5143\u6570\u636e\u5ba1\u6838\u7684\u89c4\u7a0b\uff0c\u5e94\u89c4\u5b9a\u5ba1\u6838\u6d3b\u52a8\u7684\u9891\u7387\u3001\u89d2\u8272\u548c\u804c\u8d23\uff0c\u4ee5\u53ca\u5ba1\u6838\u7684\u6027\u8d28\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.6. Actions, performance of the system and acquisition of data should be traceable and identify the persons who made entries and or changes, approved decisions or performed other critical steps in system use or control.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u7684\u6d3b\u52a8\u3001\u6027\u80fd\u548c\u6570\u636e\u7684\u91c7\u96c6\u5e94\u53ef\u8ffd\u6eaf\uff0c\u5e76\u8bc6\u522b\u90a3\u4e9b\u5728\u7cfb\u7edf\u4f7f\u7528\u548c\u63a7\u5236\u4e2d\u8fdb\u884c\u8f93\u5165\u6216\u4fee\u6539\uff0c\u6279\u51c6\u51b3\u5b9a\u6216\u5b9e\u65bd\u5176\u5b83\u5173\u952e\u6b65\u9aa4\u7684\u4eba\u5458\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.7. Details &nbsp;on &nbsp;user &nbsp;profiles, &nbsp;access &nbsp;rights &nbsp;to &nbsp;systems, &nbsp;networks, &nbsp;servers, &nbsp;computerized systems and software should be documented and an up-to-date list on the individual user rights for the software, individual computer systems and networks should be maintained and subjected to change control. The level of detail should be sufficient to enable computer system validation personnel, information technology (IT) personnel\/any external auditor\/inspector to ascertain that security features of the system and of software used to obtain and process critical data cannot be circumvented.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u8bb0\u5f55\u5173\u4e8e\u7528\u6237\u914d\u7f6e\uff0c\u7cfb\u7edf\u8bbf\u95ee\u6743\u9650\uff0c\u7f51\u7edc\uff0c\u670d\u52a1\u5668\uff0c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u548c\u8f6f\u4ef6\u7684\u8be6\u7ec6\u60c5\u51b5\uff0c\u5e76\u7ef4\u62a4\u4e00\u4efd\u5b9e\u65f6\u66f4\u65b0\u7684\u6743\u9650\u6e05\u5355\u8bb0\u5f55\u8f6f\u4ef6\u3001\u4e2a\u4eba\u8ba1\u7b97\u673a\u7cfb\u7edf\u548c\u7f51\u7edc\u7684\u7528\u6237\u6743\u9650\uff0c\u5e76\u9075\u5faa\u53d8\u66f4\u63a7\u5236\u3002\u8be5\u6e05\u5355\u5e94\u8db3\u591f\u8be6\u7ec6\uff0c\u4ee5\u5e2e\u52a9\u8ba1\u7b97\u673a\u7cfb\u7edf\u9a8c\u8bc1\u4eba\u5458\u3001\u4fe1\u606f\u6280\u672f\uff08IT\uff09\u4eba\u5458\/\u4efb\u4f55\u5916\u90e8\u5ba1\u8ba1\u4eba\u5458\/\u68c0\u67e5\u4eba\u5458\u53ef\u4ee5\u786e\u5b9a\u7528\u4e8e\u83b7\u53d6\u548c\u5904\u7406\u5173\u952e\u6570\u636e\u7684\u7cfb\u7edf\u548c\u8f6f\u4ef6\u5177\u5907\u5b89\u5168\u7684\u7279\u6027\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.8. All &nbsp;GMP &nbsp;computerized systems, either stand-alone or in a network, should &nbsp;have a system commensurate to identified risks for monitoring through an audit trail events that are relevant. These events should include all elements that need to be monitored to ensure that the integrity (5) of the data could not have been compromised, such as but not limited to, changes in data,deletionofdata,dates,times,backups,archives,changesinuseraccessrights, addition\/deletion of users and logins. In accordance with WHO guidance on good data and record management practices (5). The configuration and archival of these audit trails should be documented and also be subjected to change control. These audit trails should be accurate, consistent,secure and available through out the retention period and their generation appropriately qualified.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6240\u6709 GMP \u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\uff0c\u4e0d\u7ba1\u662f\u5355\u673a\u8fd8\u662f\u7f51\u7edc\u7248\uff0c\u5e94\u5177\u5907\u4e00\u4e2a\u4e0e\u6240\u8bc6\u522b\u7684\u98ce\u9669\u76f8\u9002\u5e94\u7684\u5ba1\u8ba1\u8ffd\u8e2a\u4e8b\u4ef6\u76f8\u5173\u7684\u76d1\u6d4b\u7cfb\u7edf\u3002\u88ab\u8ffd\u8e2a\u7684\u4e8b\u4ef6\u5e94\u5305\u62ec\u6240\u6709\u9700\u8981\u88ab\u76d1\u63a7\u7684\u8981\u7d20\uff0c\u4ee5\u786e\u4fdd\u6570\u636e\u5b8c\u6574\u6027\u4e0d\u53d7\u5230\u5371\u5bb3\uff0c\u4f8b\u5982\uff08\u4f46\u4e0d\u5c40\u9650\u4e8e\uff09\uff0c\u6570\u636e\u66f4\u6539\uff0c\u6570\u636e\u5220\u9664\uff0c\u65e5\u671f\uff0c\u65f6\u95f4\uff0c\u5907\u4efd\uff0c\u5f52\u6863\uff0c\u7528\u6237\u8bbf\u95ee\u6743\u9650\u53d8\u66f4\uff0c\u7528\u6237\u548c\u767b\u9646\u8d26\u53f7\u7684\u589e\u52a0\/\u5220\u9664\u3002\u4e3a\u7b26\u5408 WHO \u300a\u6570\u636e\u548c\u8bb0\u5f55\u7ba1\u7406\u89c4\u8303\u300b\uff0c\u5e94\u8bb0\u5f55\u8fd9\u4e9b\u5ba1\u8ba1\u8ffd\u8e2a\u8bb0\u5f55\u7684\u914d\u7f6e\u548c\u5f52\u6863\uff0c\u5e76\u9075\u5faa\u53d8\u66f4\u63a7\u5236\u3002\u8fd9\u4e9b\u5ba1\u8ba1\u8ffd\u8e2a\u8bb0\u5f55\u5e94\u51c6\u786e\u3001\u4e00\u81f4\u3001\u5b89\u5168\u5e76\u5728\u6574\u4e2a\u4fdd\u5b58\u671f\u95f4\u53ef\u7528\uff0c\u5ba1\u8ba1\u8ffd\u8e2a\u7684\u751f\u6210\u5e94\u7ecf\u8fc7\u786e\u8ba4\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">Operation and maintenance<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u64cd\u4f5c\u548c\u7ef4\u62a4<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.9. Entry &nbsp;of &nbsp; data &nbsp;into &nbsp;a &nbsp;computerized &nbsp;system &nbsp;should &nbsp;be &nbsp;verified &nbsp;by &nbsp;an &nbsp;independent authorized person and locked before release for routine use.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5c06\u6570\u636e\u8f93\u5165\u5230\u4e00\u4e2a\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u8fc7\u7a0b\u5e94\u7531\u4e00\u4e2a\u72ec\u7acb\u7684\u7ecf\u6388\u6743\u7684\u4eba\u5458\u786e\u8ba4\uff0c\u5e76\u5728\u653e\u884c\u7528\u4e8e\u65e5\u5e38\u4f7f\u7528\u524d\u9501\u5b9a\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.10. Validated computerized systems should be maintained in a validated state once released to the GXP production environment.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5df2\u9a8c\u8bc1\u7684\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u5e94\u5728\u653e\u884c\u81f3 GXP \u751f\u4ea7\u73af\u5883\u540e\u4fdd\u6301\u9a8c\u8bc1\u72b6\u6001\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.11. There &nbsp;should &nbsp;be &nbsp;written &nbsp;procedures &nbsp;governing &nbsp;system &nbsp;operation &nbsp;and &nbsp;maintenance, including, for example:<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u5177\u5907\u4e66\u9762\u89c4\u7a0b\u7ba1\u7406\u7cfb\u7edf\u64cd\u4f5c\u548c\u7ef4\u62a4\uff0c\u5305\u62ec\uff1a<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<ul class=\"list-paddingleft-2\" style=\"margin-right: 0px;margin-left: 0px;\">\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">performance monitoring;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6027\u80fd\u76d1\u6d4b<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">change management and configuration management;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53d8\u66f4\u7ba1\u7406\u548c\u914d\u7f6e\u7ba1\u7406<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">problem\/incident management;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u95ee\u9898\/\u4e8b\u4ef6\u7ba1\u7406<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">program and data security;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7a0b\u5e8f\u548c\u6570\u636e\u5b89\u5168<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">program and data backup\/restore and archival\/retrieval;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7a0b\u5e8f\u548c\u6570\u636e\u5907\u4efd\/\u6062\u590d\u548c\u5f52\u6863\/\u68c0\u7d22<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">system administration and maintenance;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u7ba1\u7406\u548c\u7ef4\u62a4<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">data flow and data life cycle;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6570\u636e\u6d41\u548c\u6570\u636e\u751f\u547d\u5468\u671f<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">system use and review of electronic data and metadata (such as audit trails);&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u4f7f\u7528\u548c\u7535\u5b50\u6570\u636e\u53ca\u5143\u6570\u636e\uff08\u5982\u5ba1\u8ba1\u8ffd\u8e2a\uff09\u5ba1\u6838<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">personnel training;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4eba\u5458\u57f9\u8bad<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">disaster recovery and business continuity;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u707e\u96be\u6062\u590d\u548c\u4e1a\u52a1\u8fde\u7eed\u6027<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">availability of spare parts and technical support;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5907\u4ef6\u4f9b\u5e94\u60c5\u51b5\u548c\u6280\u672f\u652f\u6301<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">periodic re-evaluation.<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5b9a\u671f\u518d\u8bc4\u4ef7<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">Periodic review<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5468\u671f\u6027\u56de\u987e<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.12. Computerized systems should be periodically reviewed to determine whether the system remains in a validated state or whether there is a need for revalidation. The scope and extent of the revalidation should be determined using a risk-based approach. The review should at least cover:<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5e94\u5b9a\u671f\u56de\u987e\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\uff0c\u4ee5\u786e\u5b9a\u7cfb\u7edf\u662f\u5426\u4fdd\u6301\u5728\u4e00\u4e2a\u5df2\u9a8c\u8bc1\u7684\u72b6\u6001\u6216\u8005\u662f\u5426\u9700\u8981\u518d\u9a8c\u8bc1\u3002\u518d\u9a8c\u8bc1\u7684\u8303\u56f4\u548c\u7a0b\u5ea6\u5e94\u4f7f\u7528\u57fa\u4e8e\u98ce\u9669\u7684\u65b9\u6cd5\u786e\u5b9a\u3002\u56de\u987e\u5e94\u81f3\u5c11\u8986\u76d6\uff1a<\/span><\/p>\n<ul class=\"list-paddingleft-2\" style=\"margin-right: 0px;margin-left: 0px;\">\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">review of changes;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u53d8\u66f4\u56de\u987e<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">review of deviations;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u504f\u5dee\u56de\u987e<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">review of incidents\/ events;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e8b\u4ef6\u56de\u987e<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">systems documentation;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u6587\u4ef6<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">procedures;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u89c4\u7a0b<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">training;&nbsp;<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u57f9\u8bad<\/span><\/p>\n<\/li>\n<li>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\">effectiveness of corrective and preventive action (CAPA).<\/p>\n<p style=\"margin: 0px;padding: 0px;clear: both;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u6574\u6539\u9884\u9632\u63aa\u65bd CAPA \u7684\u6709\u6548\u6027<\/span><\/p>\n<\/li>\n<\/ul>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.13. CAPA should be taken where indicated as a result of the periodic review.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5f53\u5468\u671f\u6027\u56de\u987e\u7684\u7ed3\u8bba\u6307\u660e\u9700\u8981 CAPA \u65f6\uff0c\u5e94\u542f\u52a8 CAPA\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">14.14. Automatic or live updates should be subject to review prior to becoming effective.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u81ea\u52a8\u5347\u7ea7\u6216\u5728\u7ebf\u5347\u7ea7\u5e94\u5728\u6267\u884c\u524d\u8fdb\u884c\u5ba1\u6838\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">15. &nbsp;SYSTEM RETIREMENT<\/strong><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(171, 25, 66);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"><strong style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u7cfb\u7edf\u9000\u5f79<\/strong><\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">15.1. Once the computerized system or components are no longer needed, the system &nbsp;or components should be retired and decommissioned in accordance with established authorized procedures including a change control procedure and a formal plan for retirement.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u4e00\u65e6\u4e0d\u518d\u9700\u8981\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u6216\u5176\u7ec4\u4ef6\u65f6\uff0c\u7cfb\u7edf\u6216\u7ec4\u4ef6\u5e94\u6309\u7167\u5df2\u5efa\u7acb\u7ecf\u6279\u51c6\u7684\u7a0b\u5e8f\u8fdb\u884c\u9000\u5f79\u3002\u6279\u51c6\u7684\u89c4\u7a0b\u5305\u62ec\u53d8\u66f4\u63a7\u5236\u7a0b\u5e8f\u548c\u4e00\u4efd\u6b63\u5f0f\u7684\u9000\u5f79\u8ba1\u5212\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">15.2. Records should be in a readable form and in a manner that preserves the content and meaning of the source electronic records throughout the required records retention period.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u5c3d\u7ba1\u9000\u5f79\uff0c\u4ecd\u5e94\u4fdd\u6301\u5728\u6574\u4e2a\u6240\u8981\u6c42\u7684\u8bb0\u5f55\u4fdd\u5b58\u671f\u95f4\uff0c\u786e\u4fdd\u8bb0\u5f55\u7684\u53ef\u8bfb\u6027\uff0c\u5e76\u4fdd\u6301\u539f\u7535\u5b50\u8bb0\u5f55\u7684\u5185\u5bb9\u548c\u542b\u4e49\u3002<\/span><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><br style=\"margin: 0px;padding: 0px;-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box;\"  \/><\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;clear: both;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\">15.3. The &nbsp;outcome &nbsp;of &nbsp;the &nbsp;retirement &nbsp;activities, &nbsp;including &nbsp;traceability &nbsp;of &nbsp;the &nbsp;data &nbsp;and computerized systems, should be presented in a report.<\/p>\n<p style=\"margin: 0px;padding: 0px;text-align: justify;color: rgb(51, 51, 51);text-transform: none;text-indent: 0px;letter-spacing: 0.54px;word-spacing: 0px;white-space: normal;-ms-word-wrap: break-word !important;min-height: 1em;max-width: 100%;box-sizing: border-box;widows: 1;background-color: rgb(255, 255, 255);-webkit-text-stroke-width: 0px;\"><span style=\"margin: 0px;padding: 0px;color: rgb(0, 128, 255);-ms-word-wrap: break-word !important;max-width: 100%;box-sizing: border-box !important;\">\u9000\u5f79\u6d3b\u52a8\u7684\u7ed3\u679c\uff0c\u5305\u62ec\u6570\u636e\u548c\u8ba1\u7b97\u673a\u5316\u7cfb\u7edf\u7684\u53ef\u8ffd\u6eaf\u6027\uff0c\u5e94\u5448\u73b0\u5728\u62a5\u544a\u4e2d\u3002<\/span><\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u258d\u6765\u6e90\uff1aGMP\u529e\u516c\u5ba4&nbsp;&nbsp;&nbsp;\u58f0\u660e\uff1a\u8f6c\u8f7d\u53ea\u662f\u4e3a\u4e86\u5b66\u4e60\uff0c\u6d89\u53ca\u4fb5\u6743\uff0c\u7acb\u5373\u5220\u9664\u3002 \u9002\u5f53\u7a0b\u5ea6 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":59683,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/59682"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=59682"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/59682\/revisions"}],"predecessor-version":[{"id":59706,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/59682\/revisions\/59706"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/59683"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=59682"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=59682"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=59682"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}