{"id":1543,"date":"2021-10-29T17:40:22","date_gmt":"2021-10-29T09:40:22","guid":{"rendered":"https:\/\/www.sunrise.tw\/?p=1543"},"modified":"2021-11-05T13:56:46","modified_gmt":"2021-11-05T05:56:46","slug":"%e5%93%81%e8%b3%aa%e7%ae%a1%e7%90%86%e7%b3%bb%e7%b5%b1%e4%b8%8d%e5%8f%af%e6%88%96%e7%bc%ba%e7%9a%84%e5%85%ad%e5%a4%a7%e8%a6%81%e7%b4%a0","status":"publish","type":"post","link":"https:\/\/www.sunrise.tw\/?p=1543","title":{"rendered":"\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u4e0d\u53ef\u6216\u7f3a\u7684\u516d\u5927\u8981\u7d20"},"content":{"rendered":"\n<p>\u6211\u5011\u90fd\u77e5\u9053\u54c1\u8cea\u548c\u5408\u898f\u5718\u968a\u5e38\u88ab\u8996\u70ba\u7d44\u7e54\u4e2d\u7684\u300c\u963b\u529b\u300d\uff0c\u4f46\u8ffd\u6839\u7a76\u5e95\uff0c\u7a76\u7adf\u662f\u4ec0\u9ebc\u62c9\u958b\u60a8\u8207\u7af6\u722d\u5c0d\u624b\u7684\u8ddd\u96e2\uff1f\u5275\u65b0\uff1f\u7d93\u71df\u7b56\u7565\uff1f\u5546\u696d\u5316\uff1f\u4e5f\u8a31\u5427\uff0c\u4f46\u5982\u679c\u60a8\u4e0a\u5e02\u7684\u7522\u54c1\u4e0d\u751a\u5b8c\u7f8e\uff0c\u9019\u4e9b\u56e0\u7d20\u5168\u90fd\u6d3e\u4e0d\u4e0a\u7528\u5834\u3002<\/p>\n\n\n<style 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class=\"kt-inside-inner-col\">\n<h3>\u81ea\u52d5\u5316\u6d41\u7a0b<\/h3>\n\n\n\n<p>\u81ea\u52d5\u57f7\u884c\u6240\u6709\u54c1\u8cea\u76f8\u95dc\u4efb\u52d9\uff0c\u4f8b\u5982\u6587\u4ef6\u548c\u8868\u683c\u7684\u7c3d\u6838\u3001\u8ffd\u8e2a\uff0c\u5305\u62ec\u4f46\u4e0d\u50c5\u9650\u65bc SOP\u3001\u6559\u80b2\u8a13\u7df4\u8a18\u9304\u3001\u96fb\u5b50\u6279\u6b21\u8a18\u9304\u3001\u54c1\u8cea\u4e8b\u4ef6\u8abf\u67e5\u4ee5\u53ca\u4efb\u4f55\u5176\u4ed6\u9700\u8981\u5be9\u67e5\u548c\u6838\u51c6\u7684\u5167\u5bb9\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_956055-e1\">@media all and (min-width: 768px){#kt-layout-id_956055-e1 > .kt-row-column-wrap > .inner-column-1{flex:0 1 25%;-webkit-flex:0 1 25%;}#kt-layout-id_956055-e1 > .kt-row-column-wrap > .inner-column-2{flex:0 1 75%;-webkit-flex:0 1 75%;}}#kt-layout-id_956055-e1 > .kt-row-column-wrap{padding-top:5px;padding-bottom:5px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout alignnone\"><div id=\"kt-layout-id_956055-e1\" class=\"kt-row-layout-inner kt-layout-id_956055-e1\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-right-golden kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row  kt-custom-first-width-25  kt-custom-second-width-75\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_75e747-f0\"><div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-icon kt-svg-icons kt-svg-icons_468379-d6 aligncenter\" style=\"text-align:center\"><div class=\"kt-svg-style-default kt-svg-icon-wrap kt-svg-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center;color:#444444\" class=\"kt-svg-icon kt-svg-icon-fe_link\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"35\" width=\"35\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><path d=\"M10 13a5 5 0 0 0 7.54.54l3-3a5 5 0 0 0-7.07-7.07l-1.72 1.71\"><\/path><path d=\"M14 11a5 5 0 0 0-7.54-.54l-3 3a5 5 0 0 0 7.07 7.07l1.71-1.71\"><\/path><\/svg><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_2be107-bd\"><div class=\"kt-inside-inner-col\">\n<h3>\u9023\u7d50\u54c1\u8cea\u7ba1\u7406\u7684\u6240\u6709\u9762\u5411<\/h3>\n\n\n\n<p>\u6587\u4ef6\u7ba1\u7406\u3001\u6559\u80b2\u8a13\u7df4\u3001\u8b8a\u66f4\u7ba1\u5236\u3001CAPA\u7b49\u8cc7\u6e90\u9808\u88ab\u4e32\u806f\uff0c\u54c1\u8cea\u7cfb\u7d71\u6700\u597d\u4e5f\u80fd\u548c\u88fd\u9020\u57f7\u884c\u7cfb\u7d71 (MES) \u6216\u96fb\u5b50\u6279\u6b21\u7d00\u9304\u7cfb\u7d71 (eBR) \u5171\u4eab\u6578\u64da\uff0c\u4ee5\u512a\u5316\u88fd\u68d7\u54c1\u8cea\u7ba1\u7406\u3002\u54c1\u8cea\u6578\u64da\u8981\u80fd\u7531\u4e0d\u540c\u7d44\u7e54\u7d50\u69cb\u3001\u751a\u81f3\u662f\u8de8\u7d44\u7e54\u7684\u4f7f\u7528\u8005\u4f9d\u6b0a\u9650\u95b1\u89bd\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_f0dcfd-85\">@media all and (min-width: 768px){#kt-layout-id_f0dcfd-85 > .kt-row-column-wrap > .inner-column-1{flex:0 1 25%;-webkit-flex:0 1 25%;}#kt-layout-id_f0dcfd-85 > .kt-row-column-wrap > .inner-column-2{flex:0 1 75%;-webkit-flex:0 1 75%;}}#kt-layout-id_f0dcfd-85 > .kt-row-column-wrap{padding-top:5px;padding-bottom:5px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout alignnone\"><div id=\"kt-layout-id_f0dcfd-85\" class=\"kt-row-layout-inner kt-layout-id_f0dcfd-85\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-right-golden kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row  kt-custom-first-width-25  kt-custom-second-width-75\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_5e6b0a-da\"><div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-icon kt-svg-icons kt-svg-icons_471858-ed aligncenter\" style=\"text-align:center\"><div class=\"kt-svg-style-default kt-svg-icon-wrap kt-svg-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center;color:#444444\" class=\"kt-svg-icon kt-svg-icon-fe_layers\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"35\" width=\"35\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polygon points=\"12 2 2 7 12 12 22 7 12 2\"><\/polygon><polyline points=\"2 17 12 22 22 17\"><\/polyline><polyline points=\"2 12 12 17 22 12\"><\/polyline><\/svg><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_131832-0c\"><div class=\"kt-inside-inner-col\">\n<h3>\u5177\u5099\u6578\u64da\u5206\u6790<\/h3>\n\n\n\n<p>\u5728\u7576\u4eca\u7af6\u722d\u6fc0\u70c8\u7684\u88fd\u9020\u74b0\u5883\u4e2d\uff0cQMS \u4e0d\u50c5\u8981\u63d0\u4f9b\u54c1\u8cea\u6578\u64da\uff0c\u9084\u8981\u5e6b\u52a9\u4f7f\u7528\u8005\u6df1\u5165\u5206\u6790\u54c1\u8cea\u7ba1\u7406\uff0c\u4ee5\u6578\u64da\u5c0e\u5411\u6c7a\u7b56\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_281f05-58\">@media all and (min-width: 768px){#kt-layout-id_281f05-58 > .kt-row-column-wrap > .inner-column-1{flex:0 1 25%;-webkit-flex:0 1 25%;}#kt-layout-id_281f05-58 > .kt-row-column-wrap > .inner-column-2{flex:0 1 75%;-webkit-flex:0 1 75%;}}#kt-layout-id_281f05-58 > .kt-row-column-wrap{padding-top:5px;padding-bottom:5px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout alignnone\"><div id=\"kt-layout-id_281f05-58\" class=\"kt-row-layout-inner kt-layout-id_281f05-58\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-right-golden kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row  kt-custom-first-width-25  kt-custom-second-width-75\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_7bcc13-6a\"><div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-icon kt-svg-icons kt-svg-icons_df228f-db aligncenter\" style=\"text-align:center\"><div class=\"kt-svg-style-default kt-svg-icon-wrap kt-svg-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center;color:#444444\" class=\"kt-svg-icon kt-svg-icon-fe_maximize2\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"35\" width=\"35\" fill=\"none\" stroke=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\"><polyline points=\"15 3 21 3 21 9\"><\/polyline><polyline points=\"9 21 3 21 3 15\"><\/polyline><line x1=\"21\" y1=\"3\" x2=\"14\" y2=\"10\"><\/line><line x1=\"3\" y1=\"21\" x2=\"10\" y2=\"14\"><\/line><\/svg><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_8549e1-25\"><div class=\"kt-inside-inner-col\">\n<h3>\u53ef\u64f4\u5145\u6027<\/h3>\n\n\n\n<p>QMS \u9700\u63d0\u4f9b\u4f01\u696d\u5728\u71df\u904b\u55ae\u4f4d\u3001\u4f7f\u7528\u8005\u3001\u64cd\u4f5c\u529f\u80fd\u9019\u4e09\u5927\u9762\u5411\u7684\u53ef\u64f4\u5145\u6027\uff0c\u96a8\u8457\u4f01\u696d\u898f\u6a21\u63d0\u5347\uff0c\u6301\u7e8c\u52a0\u5f37\u54c1\u8cea\u7ba1\u7406\u7bc4\u570d\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_7ac384-7f\">@media all and (min-width: 768px){#kt-layout-id_7ac384-7f > .kt-row-column-wrap > .inner-column-1{flex:0 1 25%;-webkit-flex:0 1 25%;}#kt-layout-id_7ac384-7f > .kt-row-column-wrap > .inner-column-2{flex:0 1 75%;-webkit-flex:0 1 75%;}}#kt-layout-id_7ac384-7f > .kt-row-column-wrap{padding-top:5px;padding-bottom:5px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout alignnone\"><div id=\"kt-layout-id_7ac384-7f\" class=\"kt-row-layout-inner kt-layout-id_7ac384-7f\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-right-golden kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row  kt-custom-first-width-25  kt-custom-second-width-75\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_d0ec95-d8\"><div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-icon kt-svg-icons kt-svg-icons_d7e3e0-e4 aligncenter\" style=\"text-align:center\"><div class=\"kt-svg-style-default kt-svg-icon-wrap kt-svg-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center;color:#444444\" class=\"kt-svg-icon kt-svg-icon-ic_briefcase\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 8 8\" height=\"30\" width=\"30\" fill=\"currentColor\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M3 0c-.55 0-1 .45-1 1v1h-1.91c-.06 0-.09.04-.09.09v2.41c0 .28.22.5.5.5h7c.28 0 .5-.22.5-.5v-2.41c0-.06-.04-.09-.09-.09h-1.91v-1c0-.55-.45-1-1-1h-2zm0 1h2v1h-2v-1zm-3 4.91v2c0 .05.04.09.09.09h7.81c.05 0 .09-.04.09-.09v-2c-.16.06-.32.09-.5.09h-7c-.18 0-.34-.04-.5-.09z\"><\/path><\/svg><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_f10dc2-03\"><div class=\"kt-inside-inner-col\">\n<h3>\u512a\u79c0\u4e14\u65b9\u4fbf\u7684\u6559\u80b2\u8a13\u7df4\u7ba1\u7406<\/h3>\n\n\n\n<p>\u6559\u80b2\u8a13\u7df4\u4e0d\u78ba\u5be6\u662f\u6536\u5230 FDA 483 Form \u7684\u4e3b\u8981\u539f\u56e0\u4e4b\u4e00\u3002\u4e00\u662f\u7f3a\u4e4f\u6548\u7387\u3001\u76f4\u89c0\u6027\u548c\u95dc\u806f\u6027\uff0c\u4ee3\u8868\u4f01\u696d\u54e1\u5de5\u7121\u6cd5\u6309\u7167\u6a19\u6e96\u57f7\u884c\u4efb\u52d9\uff1b\u4e8c\u662f\u5373\u4f7f\u54e1\u5de5\u901a\u904e\u6559\u80b2\u8a13\u7df4\uff0c\u4e5f\u5f88\u96e3\u627e\u5230\u8b49\u660e\u6587\u4ef6\u3002QMS \u9808\u80fd\u900f\u904e\u65b9\u4fbf\u7684\u6559\u80b2\u8a13\u7df4\u7ba1\u7406\u5f4c\u88dc\u4e0a\u8ff0\u4e0d\u8db3\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_44888d-39\">@media all and (min-width: 768px){#kt-layout-id_44888d-39 > .kt-row-column-wrap > .inner-column-1{flex:0 1 25%;-webkit-flex:0 1 25%;}#kt-layout-id_44888d-39 > .kt-row-column-wrap > .inner-column-2{flex:0 1 75%;-webkit-flex:0 1 75%;}}#kt-layout-id_44888d-39 > .kt-row-column-wrap{padding-top:5px;padding-bottom:5px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout alignnone\"><div id=\"kt-layout-id_44888d-39\" class=\"kt-row-layout-inner kt-layout-id_44888d-39\"><div class=\"kt-row-column-wrap kt-has-2-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-right-golden kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row  kt-custom-first-width-25  kt-custom-second-width-75\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_a1ff02-59\"><div class=\"kt-inside-inner-col\">\n<div class=\"wp-block-kadence-icon kt-svg-icons kt-svg-icons_5a279c-78 aligncenter\" style=\"text-align:center\"><div class=\"kt-svg-style-default kt-svg-icon-wrap kt-svg-item-0\"><div style=\"display:inline-flex;justify-content:center;align-items:center;color:#444444\" class=\"kt-svg-icon kt-svg-icon-fe_userCheck\"><svg style=\"display:inline-block;vertical-align:middle\" viewbox=\"0 0 24 24\" height=\"35\" width=\"35\" 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 9\"><\/polyline><\/svg><\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_307386-b0\"><div class=\"kt-inside-inner-col\">\n<h3>\u6301\u7e8c\u78ba\u6548<\/h3>\n\n\n\n<p>QMS \u7cfb\u7d71\u9808\u80fd\u6301\u7e8c\u88ab\u78ba\u4fdd\u70ba\u901a\u904e\u78ba\u6548\u72c0\u614b\uff0c\u4ee5\u7b26\u5408 FDA \u8981\u6c42\u4e26\u78ba\u4fdd\u7cfb\u7d71\u7b26\u5408\u4f7f\u7528\u8005\u9810\u671f\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-spacer_b0d9f6-22\">.wp-block-kadence-spacer.kt-block-spacer-_b0d9f6-22 .kt-block-spacer{height:30px;}.wp-block-kadence-spacer.kt-block-spacer-_b0d9f6-22 .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_b0d9f6-22\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:30px\"><\/div><\/div>\n\n\n\n<h2>MasterControl \u591a\u5408\u4e00\u7684\u5e73\u53f0\u5316\u754c\u9762<\/h2>\n\n\n<style id=\"kb-spacer_54499e-9d\">.wp-block-kadence-spacer.kt-block-spacer-_54499e-9d .kt-block-spacer{height:10px;}.wp-block-kadence-spacer.kt-block-spacer-_54499e-9d .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_54499e-9d\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:10px\"><\/div><\/div>\n\n\n\n<p>\u73fe\u5728\u662f\u6642\u5019\u900f\u904e MasterControl Quality Excellence\u2122 \u5c07\u54c1\u8cea\u548c\u7d55\u4f73\u7d93\u71df\u6a21\u5f0f\u4e92\u76f8\u7d50\u5408\u4e86\u3002MasterControl Quality Excellence\u2122 \u8f15\u9b06\u9054\u5230<\/p>\n\n\n<style id=\"kb-rowlayout_e0ed8c-fa\">#kt-layout-id_e0ed8c-fa{background-color:rgba(238,238,238,0.32);}#kt-layout-id_e0ed8c-fa > .kt-row-column-wrap{padding-top:10px;padding-bottom:10px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout aligncenter\"><div id=\"kt-layout-id_e0ed8c-fa\" class=\"kt-row-layout-inner kt-row-has-bg kt-layout-id_e0ed8c-fa\"><div class=\"kt-blocks-carousel kb-blocks-bg-slider kt-carousel-container-dotstyle-dark\"><div class=\"kt-blocks-carousel-init kb-blocks-bg-slider-init kt-carousel-arrowstyle-none kt-carousel-dotstyle-dark\" data-slider-anim-speed=\"400\" data-slider-type=\"slider\" data-slider-scroll=\"1\" data-slider-arrows=\"false\" data-slider-fade=\"true\" data-slider-dots=\"true\" data-slider-hover-pause=\"false\" data-slider-auto=\"true\" data-slider-speed=\"7000\"><div class=\"kb-bg-slide-contain\"><div class=\"kb-bg-slide kb-bg-slide-0\" style=\"background-size:cover;background-position:center center;background-repeat:no-repeat\"><\/div><\/div><\/div><\/div><div class=\"kt-row-column-wrap kt-has-3-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_93d64d-e4\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">1.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u81ea\u52d5\u5316\u6587\u4ef6\u548c\u8b8a\u66f4\u7ba1\u7406<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_0ceec7-fc\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">2.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u7c21\u5316\u6240\u6709\u54e1\u5de5\u6559\u80b2\u8a13\u7df4\u7684\u7ba1\u7406\u3001\u8ffd\u8e64\u548c\u9a57\u8b49\u3002<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-3 kadence-column_e7a1b3-92\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">3.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u81ea\u52d5\u5316\u7dda\u4e0a\u8003\u8a66\u7684\u7ba1\u7406\u548c\u8a55\u5206\uff0c\u78ba\u4fdd\u6240\u6709\u54e1\u5de5\u90fd\u80fd\u6309\u7167\u65e2\u5b9a\u6587\u4ef6\u52dd\u4efb\u5de5\u4f5c\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-spacer_f7e4bf-4b\">.wp-block-kadence-spacer.kt-block-spacer-_f7e4bf-4b .kt-block-spacer{height:10px;}.wp-block-kadence-spacer.kt-block-spacer-_f7e4bf-4b .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_f7e4bf-4b\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:10px\"><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_55e074-3e\">#kt-layout-id_55e074-3e{background-color:rgba(238,238,238,0.32);}#kt-layout-id_55e074-3e > .kt-row-column-wrap{padding-top:10px;padding-bottom:10px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout aligncenter\"><div id=\"kt-layout-id_55e074-3e\" class=\"kt-row-layout-inner kt-row-has-bg kt-layout-id_55e074-3e\"><div class=\"kt-blocks-carousel kb-blocks-bg-slider kt-carousel-container-dotstyle-dark\"><div class=\"kt-blocks-carousel-init kb-blocks-bg-slider-init kt-carousel-arrowstyle-none kt-carousel-dotstyle-dark\" data-slider-anim-speed=\"400\" data-slider-type=\"slider\" data-slider-scroll=\"1\" data-slider-arrows=\"false\" data-slider-fade=\"true\" data-slider-dots=\"true\" data-slider-hover-pause=\"false\" data-slider-auto=\"true\" data-slider-speed=\"7000\"><div class=\"kb-bg-slide-contain\"><div class=\"kb-bg-slide kb-bg-slide-0\" style=\"background-size:cover;background-position:center center;background-repeat:no-repeat\"><\/div><\/div><\/div><\/div><div class=\"kt-row-column-wrap kt-has-3-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_6a1b9f-b0\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">4.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u64f7\u53d6\u5404\u7a2e\u54c1\u8cea\u548c\u975e\u54c1\u8cea\u4e8b\u4ef6\uff0c\u4e26\u5c07\u6709\u6548\u554f\u984c\u4e0a\u5831\u81f3\u9069\u7576\u7684\u7ba1\u9053\u3002<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_2a1970-a0\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">5.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u78ba\u4fdd\u6240\u6709\u8207\u98a8\u96aa\u76f8\u95dc\u7684\u6d3b\u52d5\u9075\u5faa\u98a8\u96aa\u627f\u53d7\u80fd\u529b\u81e8\u754c\u9ede\uff0c\u4e26\u6df1\u5165\u5206\u6790\u98a8\u96aa\u8a55\u4f30\u548c\u7de9\u89e3\u6d3b\u52d5\u3002<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-3 kadence-column_fd3f8a-db\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">6.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u900f\u904e Validation Excellence Tool (VxT)\u2122 \u6301\u7e8c\u66f4\u65b0\u78ba\u6548\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-spacer_3c9f88-f7\">.wp-block-kadence-spacer.kt-block-spacer-_3c9f88-f7 .kt-block-spacer{height:10px;}.wp-block-kadence-spacer.kt-block-spacer-_3c9f88-f7 .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_3c9f88-f7\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:10px\"><\/div><\/div>\n\n\n<style id=\"kb-rowlayout_34907a-0b\">#kt-layout-id_34907a-0b{background-color:rgba(238,238,238,0.32);}#kt-layout-id_34907a-0b > .kt-row-column-wrap{padding-top:10px;padding-bottom:10px;}<\/style>\n<div class=\"wp-block-kadence-rowlayout aligncenter\"><div id=\"kt-layout-id_34907a-0b\" class=\"kt-row-layout-inner kt-row-has-bg kt-layout-id_34907a-0b\"><div class=\"kt-blocks-carousel kb-blocks-bg-slider kt-carousel-container-dotstyle-dark\"><div class=\"kt-blocks-carousel-init kb-blocks-bg-slider-init kt-carousel-arrowstyle-none kt-carousel-dotstyle-dark\" data-slider-anim-speed=\"400\" data-slider-type=\"slider\" data-slider-scroll=\"1\" data-slider-arrows=\"false\" data-slider-fade=\"true\" data-slider-dots=\"true\" data-slider-hover-pause=\"false\" data-slider-auto=\"true\" data-slider-speed=\"7000\"><div class=\"kb-bg-slide-contain\"><div class=\"kb-bg-slide kb-bg-slide-0\" style=\"background-size:cover;background-position:center center;background-repeat:no-repeat\"><\/div><\/div><\/div><\/div><div class=\"kt-row-column-wrap kt-has-3-columns kt-gutter-default kt-v-gutter-default kt-row-valign-top kt-row-layout-equal kt-tab-layout-inherit kt-m-colapse-left-to-right kt-mobile-layout-row\">\n<div class=\"wp-block-kadence-column inner-column-1 kadence-column_34e392-26\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\">7.<\/h3>\n\n\n\n<p class=\"has-text-align-center\">\u53ef\u8207 MasterControl Manufacturing Excellence\u2122 \u96fb\u5b50\u6279\u6b21\u7d00\u9304\u9023\u52d5\u3002<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-2 kadence-column_fd8722-3c\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\"><\/h3>\n\n\n\n<p class=\"has-text-align-center\"><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-column inner-column-3 kadence-column_7b2acf-24\"><div class=\"kt-inside-inner-col\">\n<h3 class=\"has-text-align-center\"><\/h3>\n\n\n\n<p class=\"has-text-align-center\"><\/p>\n<\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style id=\"kb-spacer_03bdaf-de\">.wp-block-kadence-spacer.kt-block-spacer-_03bdaf-de .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_03bdaf-de\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:60px\"><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<h4>\u53c3\u8003\u8cc7\u6599<\/h4>\n\n\n\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items_78fd24-77 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\/mc-tb-quality-data-management-and-integrity-for-the-life-sciences-it.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">2020 Trends in Quality Data Management and Integrity for the Life Sciences.<\/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_9f4c0c-c8 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\/2021-mc-ib-6-must-haves-for-a-quality-management-system-ltbfdd0e7796026559b82aff0000ccbde2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">6 Must-Haves for a Quality Management System (QMS).<\/a><\/span><\/li><\/ul><\/div>\n\n\n<style id=\"kb-spacer_190903-12\">.wp-block-kadence-spacer.kt-block-spacer-_190903-12 .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_190903-12\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:60px\"><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<h4>\u9023\u7d50\u7522\u54c1<\/h4>\n\n\n\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items_9995e5-70 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\/?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_a4a1f2-51 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 \u7684\u6210\u672c\u548c\u8907\u96dc\u5ea6\uff0c\u63d0\u4f9b\u7b2c\u4e00\u6b21\u5c31\u505a\u5c0d\u7684\u6210\u679c\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_a0af60-a2 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\">MasterControl Clinical Excellence\uff1a\u5728\u55ae\u4e00\u5e73\u53f0\u4e0a\u6574\u5408\u81e8\u5e8a\u71df\u904b\u8207\u81e8\u5e8a\u54c1\u8cea\u6d41\u7a0b\uff0c\u5354\u52a9\u60a8\u5728\u6574\u500b\u81e8\u5e8a\u8a66\u9a57\u751f\u547d\u9031\u671f\u4e2d\u6709\u6548\u7ba1\u7406\u3001\u9023\u7d50\u3001\u8ffd\u8e64\u3001\u6574\u7406\u548c\u5132\u5b58\u6240\u6709\u95dc\u9375\u7684\u96fb\u5b50\u8a66\u9a57\u4e3b\u8981\u6a94\u6848 (eTMF) \u5167\u5bb9\u3002<\/span><\/li><\/ul><\/div>\n\n\n\n<div class=\"wp-block-kadence-iconlist kt-svg-icon-list-items kt-svg-icon-list-items_88eda7-ae 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\">MasterControl Regulatory Excellence\uff1a\u5c07\u5167\u5bb9\u7ba1\u7406\u8207\u548c\u8a3b\u518a\u63d0\u4ea4\u529f\u80fd\u76f8\u7d50\u5408\uff0c\u4ee5\u5354\u8abf\u76e3\u7ba1\u548c\u8cea\u91cf\u6d41\u7a0b\u3001\u7c21\u5316\u5168\u7403\u63d0\u4ea4\u4e26\u52a0\u5feb\u4e0a\u5e02\u6642\u9593\u3002<\/span><\/li><\/ul><\/div>\n\n\n<style id=\"kb-spacer_28bab1-e7\">.wp-block-kadence-spacer.kt-block-spacer-_28bab1-e7 .kt-divider{width:80%;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-_28bab1-e7\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\" style=\"height:60px\"><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u6211\u5011\u90fd\u77e5\u9053\u54c1\u8cea\u548c\u5408\u898f\u5718\u968a\u5e38\u88ab\u8996\u70ba\u7d44\u7e54\u4e2d\u7684 &hellip; <a class=\"kt-excerpt-readmore more-link\" href=\"https:\/\/www.sunrise.tw\/?p=1543\">Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":1575,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":""},"categories":[18],"tags":[39,34,33],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.10 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>\u54c1\u8cea\u7ba1\u7406\u7cfb\u7d71\u4e0d\u53ef\u6216\u7f3a\u7684\u516d\u5927\u8981\u7d20 | Sunrise \u751f\u840a<\/title>\r\n<meta name=\"description\" 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