{"id":1458,"date":"2021-10-22T13:21:23","date_gmt":"2021-10-22T05:21:23","guid":{"rendered":"https:\/\/www.sunrise.tw\/?p=1458"},"modified":"2021-11-05T14:00:11","modified_gmt":"2021-11-05T06:00:11","slug":"mastercontrol-%e5%a6%82%e4%bd%95%e6%8e%a8%e5%8b%95%e4%bc%81%e6%a5%ad%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%e6%95%b8%e4%bd%8d%e8%bd%89%e5%9e%8b","status":"publish","type":"post","link":"https:\/\/www.sunrise.tw\/?p=1458","title":{"rendered":"MasterControl 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id=\"kt-info-box_85d68d-3d\" class=\"wp-block-kadence-infobox\"><a class=\"kt-blocks-info-box-link-wrap info-box-link kt-blocks-info-box-media-align-top kt-info-halign-center\"><div class=\"kt-blocks-info-box-media-container\"><div class=\"kt-blocks-info-box-media kt-info-media-animate-none\"><div class=\"kadence-info-box-icon-container kt-info-icon-animate-none\"><div class=\"kadence-info-box-icon-inner-container\"><span style=\"display:block;justify-content:center;align-items:center\" class=\"kt-info-svg-icon kt-info-svg-icon-fe_userCheck\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"30\" width=\"30\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M16 21v-2a4 4 0 0 0-4-4H5a4 4 0 0 0-4 4v2\"><\/path><circle cx=\"8.5\" cy=\"7\" r=\"4\"><\/circle><polyline points=\"17 11 19 13 23 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stroke-linejoin=\"round\"><path d=\"M16 21v-2a4 4 0 0 0-4-4H5a4 4 0 0 0-4 4v2\"><\/path><circle cx=\"8.5\" cy=\"7\" r=\"4\"><\/circle><polyline points=\"17 11 19 13 23 9\"><\/polyline><\/svg><\/span><\/div><\/div><\/div><\/div><div class=\"kt-infobox-textcontent\"><h5 class=\"kt-blocks-info-box-title\">\u5408\u898f\u6027\u63d0\u5347\uff0c\u66f4\u80fd\u9762\u5c0d\u570b\u5916\u4e0a\u4e0b\u6e38\u5ee0\u5546\u7a3d\u6838\u6216\u570b\u5916\u516c\u90e8\u9580\u7a3d\u6838<\/h5><\/div><\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2>\u6578\u4f4d\u8f49\u578b\u898f\u5283<\/h2>\n\n\n<style id=\"kb-infobox_e9149b-a5\">#kt-info-box_e9149b-a5 .kt-blocks-info-box-link-wrap:hover{border-color:#eeeeee;background:#f2f2f2;}#kt-info-box_e9149b-a5 .kt-info-svg-icon, #kt-info-box_e9149b-a5 .kt-info-svg-icon-flip, #kt-info-box_e9149b-a5 .kt-blocks-info-box-number{font-size:30px;}#kt-info-box_e9149b-a5 .kt-blocks-info-box-media{color:#444444;}#kt-info-box_e9149b-a5 .kt-blocks-info-box-link-wrap:hover .kt-blocks-info-box-media{color:#444444;}#kt-info-box_e9149b-a5 .kt-blocks-info-box-title{padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-top:5px;margin-right:0px;margin-bottom:5px;margin-left:0px;}#kt-info-box_e9149b-a5 .kt-blocks-info-box-text{padding-top:5px;padding-right:5px;padding-bottom:5px;padding-left:5px;margin-top:15px;margin-right:15px;margin-bottom:15px;margin-left:15px;}<\/style>\n<div id=\"kt-info-box_e9149b-a5\" class=\"wp-block-kadence-infobox\"><a class=\"kt-blocks-info-box-link-wrap info-box-link kt-blocks-info-box-media-align-top kt-info-halign-center\"><div class=\"kt-blocks-info-box-media-container\"><div class=\"kt-blocks-info-box-media kt-info-media-animate-none\"><div class=\"kadence-info-box-icon-container kt-info-icon-animate-none\"><div class=\"kadence-info-box-icon-inner-container\"><span style=\"display:block;justify-content:center;align-items:center\" class=\"kt-info-svg-icon kt-info-svg-icon-fe_edit3\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"30\" width=\"30\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polygon points=\"14 2 18 6 7 17 3 17 3 13 14 2\"><\/polygon><line x1=\"3\" y1=\"22\" x2=\"21\" y2=\"22\"><\/line><\/svg><\/span><\/div><\/div><\/div><\/div><div class=\"kt-infobox-textcontent\"><h3 class=\"kt-blocks-info-box-title\">\u4ee5\u5c0f\u578b\u667a\u6167\u6280\u8853\u8d77\u6b65<\/h3><p class=\"kt-blocks-info-box-text\">\u4ee5\u300c\u5c0f\u578b\u81ea\u52d5\u5316\u300d\u4f5c\u6cd5\u4f5c\u70ba\u9081\u5411\u6578\u4f4d\u8f49\u578b\u7684\u7b2c\u4e00\u6b65\u3002\u8457\u91cd\u904b\u7528\u5c0f\u898f\u6a21\u667a\u6167\u6280\u8853\u8b8a\u9769\uff0c\u6539\u5584\u7279\u5b9a\u9818\u57df\u7de0\u9020\u5f71\u97ff\u3002\u6bd4\u8d77\u5927\u898f\u6a21 IT \u63aa\u65bd\uff0c\u9019\u6a23\u7684\u4f5c\u6cd5\u66f4\u5bb9\u6613\u5be6\u65bd\u3001\u66f4\u6709\u5f48\u6027\u4e14\u66f4\u7d93\u6fdf\u5be6\u60e0\u3002<\/p><\/div><\/a><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<style id=\"kb-infobox_696bd2-1b\">#kt-info-box_696bd2-1b .kt-blocks-info-box-link-wrap:hover{border-color:#eeeeee;background:#f2f2f2;}#kt-info-box_696bd2-1b .kt-info-svg-icon, #kt-info-box_696bd2-1b .kt-info-svg-icon-flip, #kt-info-box_696bd2-1b .kt-blocks-info-box-number{font-size:30px;}#kt-info-box_696bd2-1b .kt-blocks-info-box-media{color:#444444;}#kt-info-box_696bd2-1b .kt-blocks-info-box-link-wrap:hover .kt-blocks-info-box-media{color:#444444;}#kt-info-box_696bd2-1b .kt-blocks-info-box-title{padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-top:5px;margin-right:0px;margin-bottom:5px;margin-left:0px;}#kt-info-box_696bd2-1b .kt-blocks-info-box-text{padding-top:5px;padding-right:5px;padding-bottom:5px;padding-left:5px;margin-top:15px;margin-right:15px;margin-bottom:15px;margin-left:15px;}<\/style>\n<div id=\"kt-info-box_696bd2-1b\" class=\"wp-block-kadence-infobox\"><a class=\"kt-blocks-info-box-link-wrap info-box-link kt-blocks-info-box-media-align-top kt-info-halign-center\"><div class=\"kt-blocks-info-box-media-container\"><div class=\"kt-blocks-info-box-media kt-info-media-animate-none\"><div class=\"kadence-info-box-icon-container kt-info-icon-animate-none\"><div class=\"kadence-info-box-icon-inner-container\"><span style=\"display:block;justify-content:center;align-items:center\" class=\"kt-info-svg-icon kt-info-svg-icon-fe_edit3\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"30\" width=\"30\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polygon points=\"14 2 18 6 7 17 3 17 3 13 14 2\"><\/polygon><line x1=\"3\" y1=\"22\" x2=\"21\" y2=\"22\"><\/line><\/svg><\/span><\/div><\/div><\/div><\/div><div class=\"kt-infobox-textcontent\"><h3 class=\"kt-blocks-info-box-title\">\u512a\u5148\u4fdd\u969c\u4e92\u9023\u6027<\/h3><p class=\"kt-blocks-info-box-text\">\u70ba\u5be6\u73fe\u6578\u4f4d\u8f49\u578b\u7684\u9577\u9060\u5229\u76ca\uff0c\u7d44\u7e54\u9700\u4fdd\u969c\u8cc7\u8a0a\u4e92\u9023\u6027\u4e26\u6d88\u9664\u8cc7\u8a0a\u5b64\u5cf6\u3002\u900f\u904e\u5c07\u5404\u95dc\u9375\u9818\u57df (\u5305\u62ec\u7814\u767c\u3001\u88fd\u9020\u3001\u54c1\u4fdd\u3001\u54c1\u7ba1) \u7684\u6240\u6709\u76f8\u5bb9\u6280\u8853\u3001\u7cfb\u7d71\u3001\u5de5\u4f5c\u6d41\u7a0b\u3001\u4eba\u54e1\u53ca\u8cc7\u6599\u76f8\u9023\u63a5\uff0c\u7d44\u7e54\u80fd\u66f4\u6709\u6548\u7387\uff0c\u63a8\u52d5\u66f4\u667a\u6167\u3001\u66f4\u9748\u6d3b\u7684\u71df\u904b\u6a21\u5f0f\u3002<\/p><\/div><\/a><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<style id=\"kb-infobox_08a6eb-6c\">#kt-info-box_08a6eb-6c .kt-blocks-info-box-link-wrap:hover{border-color:#eeeeee;background:#f2f2f2;}#kt-info-box_08a6eb-6c .kt-info-svg-icon, #kt-info-box_08a6eb-6c .kt-info-svg-icon-flip, #kt-info-box_08a6eb-6c .kt-blocks-info-box-number{font-size:30px;}#kt-info-box_08a6eb-6c .kt-blocks-info-box-media{color:#444444;}#kt-info-box_08a6eb-6c .kt-blocks-info-box-link-wrap:hover .kt-blocks-info-box-media{color:#444444;}#kt-info-box_08a6eb-6c .kt-blocks-info-box-title{padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-top:5px;margin-right:0px;margin-bottom:5px;margin-left:0px;}#kt-info-box_08a6eb-6c .kt-blocks-info-box-text{padding-top:5px;padding-right:5px;padding-bottom:5px;padding-left:5px;margin-top:15px;margin-right:15px;margin-bottom:15px;margin-left:15px;}<\/style>\n<div id=\"kt-info-box_08a6eb-6c\" class=\"wp-block-kadence-infobox\"><a class=\"kt-blocks-info-box-link-wrap info-box-link kt-blocks-info-box-media-align-top kt-info-halign-center\"><div class=\"kt-blocks-info-box-media-container\"><div class=\"kt-blocks-info-box-media kt-info-media-animate-none\"><div class=\"kadence-info-box-icon-container kt-info-icon-animate-none\"><div class=\"kadence-info-box-icon-inner-container\"><span style=\"display:block;justify-content:center;align-items:center\" class=\"kt-info-svg-icon kt-info-svg-icon-fe_edit3\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"30\" width=\"30\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polygon points=\"14 2 18 6 7 17 3 17 3 13 14 2\"><\/polygon><line x1=\"3\" y1=\"22\" x2=\"21\" y2=\"22\"><\/line><\/svg><\/span><\/div><\/div><\/div><\/div><div class=\"kt-infobox-textcontent\"><h3 class=\"kt-blocks-info-box-title\">\u63a1\u7528\u96f2\u7aef\u79d1\u6280<\/h3><p class=\"kt-blocks-info-box-text\">\u900f\u904e\u6574\u5408\u7684\u96f2\u7aef\u79d1\u6280\uff0c\u7d44\u7e54\u80fd\u5728\u4e0d\u540c\u5e73\u53f0\u9593\u5354\u8abf\u904b\u4f5c\uff0c\u6d88\u5f2d\u5b64\u7acb\u8655\u5883\uff0c\u7c21\u5316\u6578\u4f4d\u8cc7\u6599\u7684\u64f7\u53d6\u3001\u5132\u5b58\u8207\u5b58\u53d6\u6d41\u7a0b<\/p><\/div><\/a><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<style id=\"kb-infobox_eeaada-0f\">#kt-info-box_eeaada-0f .kt-blocks-info-box-link-wrap:hover{border-color:#eeeeee;background:#f2f2f2;}#kt-info-box_eeaada-0f .kt-info-svg-icon, #kt-info-box_eeaada-0f .kt-info-svg-icon-flip, #kt-info-box_eeaada-0f .kt-blocks-info-box-number{font-size:30px;}#kt-info-box_eeaada-0f .kt-blocks-info-box-media{color:#444444;}#kt-info-box_eeaada-0f .kt-blocks-info-box-link-wrap:hover .kt-blocks-info-box-media{color:#444444;}#kt-info-box_eeaada-0f .kt-blocks-info-box-title{padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-top:5px;margin-right:0px;margin-bottom:5px;margin-left:0px;}#kt-info-box_eeaada-0f .kt-blocks-info-box-text{padding-top:5px;padding-right:5px;padding-bottom:5px;padding-left:5px;margin-top:15px;margin-right:15px;margin-bottom:15px;margin-left:15px;}<\/style>\n<div id=\"kt-info-box_eeaada-0f\" class=\"wp-block-kadence-infobox\"><a class=\"kt-blocks-info-box-link-wrap info-box-link kt-blocks-info-box-media-align-top kt-info-halign-center\"><div class=\"kt-blocks-info-box-media-container\"><div class=\"kt-blocks-info-box-media kt-info-media-animate-none\"><div class=\"kadence-info-box-icon-container kt-info-icon-animate-none\"><div class=\"kadence-info-box-icon-inner-container\"><span style=\"display:block;justify-content:center;align-items:center\" class=\"kt-info-svg-icon kt-info-svg-icon-fe_edit3\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"30\" width=\"30\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polygon points=\"14 2 18 6 7 17 3 17 3 13 14 2\"><\/polygon><line x1=\"3\" y1=\"22\" x2=\"21\" y2=\"22\"><\/line><\/svg><\/span><\/div><\/div><\/div><\/div><div class=\"kt-infobox-textcontent\"><h3 class=\"kt-blocks-info-box-title\">\u512a\u5148\u4fdd\u969c\u4f9b\u61c9\u5546\u5de5\u5177\u7684\u9069\u61c9\u6027<\/h3><p class=\"kt-blocks-info-box-text\">\u5728\u9060\u7aef\u5de5\u4f5c\u8207\u793e\u4ea4\u8ddd\u96e2\u7684\u6642\u4ee3\uff0c\u904b\u7528\u6578\u4f4d\u4f9b\u61c9\u5546\u7ba1\u7406\u5de5\u5177\u80fd\u5354\u52a9\u7d44\u7e54\u57f7\u884c\u9060\u7aef\u54c1\u7ba1\u6d3b\u52d5\uff0c\u5305\u62ec\u4f9b\u61c9\u5546\u7a3d\u6838\u8207\u6aa2\u67e5\u3001\u8cc7\u683c\u8a8d\u8b49\u8207\u66f4\u6b63\u884c\u52d5\u8981\u6c42\u7b49\u3002<\/p><\/div><\/a><\/div>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<style id=\"kb-infobox_9c9d0b-bd\">#kt-info-box_9c9d0b-bd .kt-blocks-info-box-link-wrap:hover{border-color:#eeeeee;background:#f2f2f2;}#kt-info-box_9c9d0b-bd .kt-info-svg-icon, #kt-info-box_9c9d0b-bd .kt-info-svg-icon-flip, #kt-info-box_9c9d0b-bd .kt-blocks-info-box-number{font-size:30px;}#kt-info-box_9c9d0b-bd .kt-blocks-info-box-media{color:#444444;}#kt-info-box_9c9d0b-bd .kt-blocks-info-box-link-wrap:hover .kt-blocks-info-box-media{color:#444444;}#kt-info-box_9c9d0b-bd .kt-blocks-info-box-title{padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;margin-top:5px;margin-right:0px;margin-bottom:5px;margin-left:0px;}#kt-info-box_9c9d0b-bd .kt-blocks-info-box-text{padding-top:5px;padding-right:5px;padding-bottom:5px;padding-left:5px;margin-top:15px;margin-right:15px;margin-bottom:15px;margin-left:15px;}<\/style>\n<div id=\"kt-info-box_9c9d0b-bd\" class=\"wp-block-kadence-infobox\"><a class=\"kt-blocks-info-box-link-wrap info-box-link kt-blocks-info-box-media-align-top kt-info-halign-center\"><div class=\"kt-blocks-info-box-media-container\"><div class=\"kt-blocks-info-box-media kt-info-media-animate-none\"><div class=\"kadence-info-box-icon-container kt-info-icon-animate-none\"><div class=\"kadence-info-box-icon-inner-container\"><span style=\"display:block;justify-content:center;align-items:center\" class=\"kt-info-svg-icon kt-info-svg-icon-fe_edit3\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"30\" width=\"30\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polygon points=\"14 2 18 6 7 17 3 17 3 13 14 2\"><\/polygon><line x1=\"3\" y1=\"22\" x2=\"21\" y2=\"22\"><\/line><\/svg><\/span><\/div><\/div><\/div><\/div><div class=\"kt-infobox-textcontent\"><h3 class=\"kt-blocks-info-box-title\">\u7c21\u5316\u76e3\u7ba1\u6d41\u7a0b<\/h3><p class=\"kt-blocks-info-box-text\">FDA \u66fe\u5efa\u8b70\u300c\u7c21\u5316\u76e3\u7ba1\u6d41\u7a0b\u4e26\u79fb\u9664\u6216\u6e1b\u5c11\u8207 FDA \u76e3\u7ba1\u6d3b\u52d5\u6709\u95dc\u7684\u4e0d\u5fc5\u8981\u8ca0\u64d4\u3002\u300d\u5c07\u54c1\u7ba1\u7cfb\u7d71\u548c\u76e3\u7ba1\u6d41\u7a0b\u7d0d\u5165\u6578\u4f4d\u5316\u76ee\u6a19\uff0c\u80fd\u6709\u52a9\u65bc\u6e1b\u5c11\u76e3\u7ba1\u7533\u8acb\u904e\u7a0b\u4e2d\u7684\u5197\u9918\uff0c\u540c\u6642\u63d0\u5347\u6548\u7387\u3002\u96f2\u7aef\u4e5f\u80fd\u7528\u4f86\u6539\u5584\u76e3\u7ba1\u6838\u51c6\u6d41\u7a0b\u3002<\/p><\/div><\/a><\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2>MasterControl \u591a\u5408\u4e00\u7684\u5e73\u53f0\u5316\u754c\u9762\u5e6b\u52a9\u6578\u4f4d\u8f49\u578b<\/h2>\n\n\n\n<div class=\"wp-container-9 wp-block-columns\">\n<div class=\"wp-container-8 wp-block-column\">\n<div class=\"wp-container-7 wp-block-columns\">\n<div class=\"wp-container-5 wp-block-column\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"1793\" height=\"743\" src=\"https:\/\/www.sunrise.tw\/wp-content\/uploads\/2021\/10\/pic-MasterControl\u5982\u4f55\u63a8\u52d5\u4f01\u696d\u54c1\u8cea\u7ba1\u7406\u6578\u4f4d\u8f49\u578b-02.png\" alt=\"\" class=\"wp-image-1471\"\/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-container-6 wp-block-column\">\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>\u6578\u4f4d\u8f49\u578b\u904e\u7a0b\u4e2d\u7684\u4f01\u696d\uff0c\u9808\u9010\u6b65\u514b\u670d\u4e0d\u540c<strong>\u7cfb\u7d71\u9593\u7684\u4e92\u901a\u6027<\/strong>\uff0c\u4ee5\u53ca\u5c0d\u5b64\u7acb\u8cc7\u6599\u7684\u8490\u96c6\u3001\u5132\u5b58\u4e26\u5206\u6790\u7684\u6311\u6230\u3002\u5e73\u53f0\u5316\u7684\u7ba1\u7406\u5de5\u5177\u8b93\u7d44\u7e54\u80fd\u9806\u66a2\u5730\u6574\u5408\u71df\u904b\u5404\u90e8\u9580\u8207\u73fe\u5834\u7684\u7cfb\u7d71\u548c\u8cc7\u6599\u4f86\u6e90\u3002\u8209\u4f8b\u4f86\u8aaa\uff0c\u767c\u751f\u67d0\u4e9b\u504f\u5dee\u4e8b\u4ef6 (Deviation) \u6642\uff0c\u53ef\u80fd\u6703\u6709\u76f8\u61c9\u7684\u77ef\u6b63\u9810\u9632\u63aa\u65bd (CAPA) \u6216\u662f\u8b8a\u66f4\u7ba1\u5236 (Change Control)\uff0c\u800c\u5169\u8005\u7686\u6703\u727d\u6d89\u5230\u65b0\u7248\u672c SOP \u53ca\u76f8\u5c0d\u61c9\u7684\u6559\u80b2\u8a13\u7df4\u3002\u5018\u4f7f\u7528\u50b3\u7d71\u7d19\u672c\u751a\u81f3\u662f\u975e\u5e73\u53f0\u5316\u7684 QMS\uff0c\u7686\u9700\u591a\u6b21\u91cd\u8907\u7d00\u9304\u540c\u6a23\u7684\u8cc7\u8a0a\uff0c\u4e14\u54c1\u8cea\u4e8b\u4ef6\u3001\u6587\u4ef6\uff0c\u8207\u6559\u80b2\u8a13\u7df4\u9593\u7684\u76f8\u4e92\u52fe\u7a3d\u4ea6\u7121\u6cd5\u6e05\u695a\u5c55\u73fe\uff0c\u9700\u8017\u8cbb\u5927\u91cf\u4eba\u529b\u8ffd\u6eaf\u500b\u5225\u6848\u4ef6\u7684\u95dc\u806f\u3002\u4f46\u82e5\u4f7f\u7528 MasterControl Qx\uff0c\u53ef\u76f4\u63a5\u5c07\u54c1\u8cea\u4e8b\u4ef6\u8207\u6587\u4ef6\u3001\u6559\u80b2\u8a13\u7df4\u76f4\u63a5\u4e32\u806f\uff0c\u901a\u904e\u4e09\u8005\u5176\u4e2d\u4e4b\u4e00\u4fbf\u53ef\u8ffd\u6eaf\u5230\u53e6\u5916\u5169\u8005\uff0c\u4e0d\u8ad6\u5728\u5e73\u6642\u7ba1\u7406\u6216\u662f\u9762\u5c0d\u7a3d\u6838\u6642\u90fd\u80fd\u5c55\u73fe\u5176\u8cc7\u8a0a\u65b9\u4fbf\u6027\u53ca\u8cc7\u6599\u771f\u5be6\u6027\u3002\u4e0b\u5716\u70ba MasterControl \u591a\u5408\u4e00\u7ba1\u7406\u5e73\u53f0\u7bc4\u4f8b\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n<\/div>\n<\/div>\n\n\n\n<h2>\u5be9\u8a08\u8ffd\u8e64 (Audit Trail)<\/h2>\n\n\n\n<div class=\"wp-container-12 wp-block-columns\">\n<div class=\"wp-container-10 wp-block-column\">\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>\u7f8e\u570b FDA 21 CFR Part 11 \u56b4\u683c\u8981\u6c42\u96fb\u5b50\u7ba1\u7406\u7cfb\u7d71\u4e4b\u96fb\u5b50\u7d00\u9304\u8207\u96fb\u5b50\u7c3d\u7ae0\u9700\u6709\u7b49\u540c\u65bc\u7d19\u672c\u7d00\u9304\u4e4b\u771f\u5be6\u6027\u8207\u53ef\u9760\u6027\uff0c\u4e14\u96fb\u5b50\u7d00\u9304\u7121\u6cd5\u88ab\u7ac4\u6539\u3001\u9020\u5047\u3001\u6216\u8986\u5beb\u3002\u96fb\u5b50\u7cfb\u7d71\u9808\u6709\u80fd\u529b\u8fa8\u5225\u7121\u6548\u6216\u66f4\u6539\u7684\u8a18\u9304\u3001\u7522\u51fa\u6e96\u78ba\u548c\u5b8c\u6574\u7684 audit trail \u4f9b\u5be9\u67e5\uff0c\u8a72\u7b49 audit trail \u9700\u5305\u62ec\u64cd\u4f5c\u54e1\u8f38\u5165\u8cc7\u8a0a\u7684\u6642\u9593\u4ee5\u53ca\u4efb\u4f55\u96fb\u5b50\u8a18\u9304\u88ab\u5275\u5efa\u3001\u4fee\u6539\u6216\u522a\u9664\u7684\u7d00\u9304\uff0c\u4e0b\u5716\u70ba MasterControl Audit Trail \u7bc4\u4f8b\u3002<\/p>\n<\/div>\n\n\n\n<div class=\"wp-container-11 wp-block-column\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" width=\"1625\" height=\"853\" src=\"https:\/\/www.sunrise.tw\/wp-content\/uploads\/2021\/10\/pic-MasterControl\u5982\u4f55\u63a8\u52d5\u4f01\u696d\u54c1\u8cea\u7ba1\u7406\u6578\u4f4d\u8f49\u578b-03.png\" alt=\"\" class=\"wp-image-1478\"\/><\/figure>\n<\/div>\n<\/div>\n\n\n<style id=\"kb-spacer_5284e4-27\">.wp-block-kadence-spacer.kt-block-spacer-_5284e4-27 .kt-block-spacer{height:20px;}.wp-block-kadence-spacer.kt-block-spacer-_5284e4-27 .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_5284e4-27\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:20px\"><hr class=\"kt-divider\" style=\"border-top-color:rgba(238, 238, 238, 1);border-top-width:1px;width:80%;border-top-style:solid\"\/><\/div><\/div>\n\n\n\n<h3>\u53c3\u8003\u8cc7\u6599<\/h3>\n\n\n\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items_2e1946-7b kt-svg-icon-list-columns-1 alignnone\"><ul class=\"kt-svg-icon-list\"><li class=\"kt-svg-icon-list-style-default kt-svg-icon-list-item-wrap kt-svg-icon-list-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center\" class=\"kt-svg-icon-list-single kt-svg-icon-list-single-fe_bookOpen\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"20\" width=\"20\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M2 3h6a4 4 0 0 1 4 4v14a3 3 0 0 0-3-3H2z\"><\/path><path d=\"M22 3h-6a4 4 0 0 0-4 4v14a3 3 0 0 1 3-3h7z\"><\/path><\/svg><\/div><span class=\"kt-svg-icon-list-text\"><a href=\"https:\/\/www.sunrise.tw\/wp-content\/uploads\/2021\/10\/MasterControl_2021\u5e74\u500b\u4eba\u5316\u91ab\u7642\u8da8_\u76e3\u6e2c\u7cbe\u6e96\u91ab\u7642\u7684\u8108\u52d5.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">\u76e3\u6e2c\u7cbe\u6e96\u91ab\u7642\u7684\u8108\u52d5 2021 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9\"><\/polyline><line x1=\"10\" y1=\"14\" x2=\"21\" y2=\"3\"><\/line><\/svg><\/div><span class=\"kt-svg-icon-list-text\"><a href=\"https:\/\/www.sunrise.tw\/?page_id=662\" target=\"_blank\" rel=\"noreferrer noopener\">MasterControl Quality Excellence\u2122\uff1a\u667a\u6167\u3001\u52d5\u614b\u7684\u4f01\u696d\u3001\u5de5\u5ee0\u548c\u4f9b\u61c9\u5546\u54c1\u8cea\u7ba1\u7406\u80fd\u8b93\u60a8\u900f\u904e\u667a\u6167\u3001\u6578\u4f4d\u89e3\u6c7a\u65b9\u6848\u7ba1\u7406\u7522\u54c1\u54c1\u8cea\u3001\u5408\u898f\u8207\u98a8\u96aa\u6d41\u7a0b\u3002<\/a><\/span><\/li><\/ul><\/div>\n\n\n\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items_0d2c7e-2e kt-svg-icon-list-columns-1 alignnone\"><ul class=\"kt-svg-icon-list\"><li class=\"kt-svg-icon-list-style-default kt-svg-icon-list-item-wrap kt-svg-icon-list-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center\" class=\"kt-svg-icon-list-single kt-svg-icon-list-single-fe_externalLink\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"20\" width=\"20\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M18 13v6a2 2 0 0 1-2 2H5a2 2 0 0 1-2-2V8a2 2 0 0 1 2-2h6\"><\/path><polyline points=\"15 3 21 3 21 9\"><\/polyline><line x1=\"10\" y1=\"14\" x2=\"21\" y2=\"3\"><\/line><\/svg><\/div><span class=\"kt-svg-icon-list-text\"><a href=\"https:\/\/www.sunrise.tw\/wp-content\/uploads\/2021\/04\/MasterControl-Manufacturing-Excellence-Traditional-Chinese.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">MasterControl Manufacturing Excellence\u2122\uff1a\u5feb\u901f\u3001\u5f48\u6027\u7684\u751f\u7522\u7ba1\u7406\u548c\u9023\u7d50\u73fe\u5834\u54e1\u5de5\u7684\u6d41\u7a0b\u548c\u7cbe\u5bc6\u88fd\u9020\u57f7\u884c\u65b9\u6cd5\uff0c\u53ef\u70ba\u60a8\u514d\u9664\u50b3\u7d71 MES 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y2=\"3\"><\/line><\/svg><\/div><span class=\"kt-svg-icon-list-text\">MasterControl Insights\u2122\uff1a\u73fe\u4ee3\u8cc7\u6599\u67b6\u69cb\u8207\u9032\u968e\u5206\u6790\u6280\u8853\uff0c\u8b93\u60a8\u5c07\u7522\u54c1\u54c1\u8cea\u548c\u71df\u904b\u8cc7\u6599\u8f49\u63db\u6210\u7af6\u722d\u512a\u52e2\u3002<\/span><\/li><\/ul><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u5168\u7403\u6578\u4f4d\u8f49\u578b\u80cc\u666f \u96a8\u8457\u5168\u7403\u88fd\u85e5\u7522\u696d\u898f\u6a21\u63d0 &hellip; <a class=\"kt-excerpt-readmore more-link\" href=\"https:\/\/www.sunrise.tw\/?p=1458\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":1494,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":""},"categories":[18],"tags":[38,34,33,32],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.10 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>MasterControl \u5982\u4f55\u63a8\u52d5\u4f01\u696d\u54c1\u8cea\u7ba1\u7406\u6578\u4f4d\u8f49\u578b | Sunrise \u751f\u840a<\/title>\r\n<meta name=\"description\" content=\"\u96a8\u8457\u5168\u7403\u88fd\u85e5\u7522\u696d\u898f\u6a21\u63d0\u5347\uff0c\u85e5\u5ee0\u53ca\u751f\u6280\u516c\u53f8\u5c0d\u65bc\u54c1\u8cea\u7ba1\u7406\u4e5f\u65e5\u76ca\u91cd\u8996\u3002\u7136\u800c\uff0c\u50b3\u7d71\u7684\u7ba1\u7406\u65b9\u5f0f\u5df2\u7015\u81e8\u8ca0\u8377\u4e0a\u9650\uff0c\u5c0d\u65bc\u5f37\u8abf\u7af6\u722d\u529b\u7684\u696d\u8005\u800c\u8a00\uff0c\u5f15\u9032\u65b0\u7684\u7ba1\u7406\u6a21\u5f0f\u624d\u662f\u6436\u4f54\u5e02\u5834\u5730\u4f4d\u7684\u6700\u4f73\u65b9\u6848\u3002\u56e0\u6b64\uff0c\u570b\u969b\u77e5\u540d\u85e5\u5ee0\u53ca\u751f\u6280\u516c\u53f8\u9010\u4e00\u5c0e\u5165\u5404\u5f0f QMS\uff0c\u6bd4\u8d77\u50b3\u7d71\u7ba1\u7406\u65b9\u5f0f\u589e\u52a0\u4e86\u4ee5\u4e0b\u5e7e\u500b\u512a\u9ede\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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