{"id":140603,"date":"2019-10-22T19:25:36","date_gmt":"2019-10-23T02:25:36","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/cde-cder-%e5%8f%a3%e8%af%91%e6%9c%8d%e5%8a%a1\/"},"modified":"2023-01-30T19:20:04","modified_gmt":"2023-01-31T02:20:04","slug":"cde-cder-%e5%8f%a3%e8%af%91%e6%9c%8d%e5%8a%a1","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/cde-cder-%e5%8f%a3%e8%af%91%e6%9c%8d%e5%8a%a1\/","title":{"rendered":"CDE IND\/NDA \u7533\u62a5\u524d\u4f1a\u8bae"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;3.22&#8243; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;0px|0px|0px|0px&#8221;][et_pb_fullwidth_header button_one_text=&#8221;\u7acb\u5373\u8054\u7cfb\u6211\u4eec&#8221; button_one_url=&#8221;https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%81%94%e7%b3%bb\/&#8221; background_overlay_color=&#8221;rgba(0,0,0,0.66)&#8221; content_max_width=&#8221;80%&#8221; content_max_width_tablet=&#8221;&#8221; 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align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;3.23&#8243; max_width=&#8221;94%&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.22&#8243; background_color=&#8221;#ffffff&#8221; background_image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/CDECDER-2.jpg&#8221; custom_padding=&#8221;35px|0px|94px|0px|false|false&#8221; hover_enabled=&#8221;0&#8243;][et_pb_row _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;0||0||false|false&#8221; column_structure=&#8221;1_2,1_2&#8243;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text disabled_on=&#8221;off|off|off&#8221; 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max_width=&#8221;100%&#8221; custom_padding=&#8221;100px||||false|false&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.5.3&#8243; _module_preset=&#8221;default&#8221;]\n\n\n<h2>\u6570\u636e\u5b89\u5168<\/h2>\n<p>\u62e5\u670920\u591a\u5e74\u533b\u5b66\u7ffb\u8bd1\u7ecf\u9a8c\u7684CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u6df1\u8c19\u6570\u636e\u5b89\u5168\u5bf9\u6211\u4eec\u5ba2\u6237\u7684\u91cd\u8981\u6027\uff0c\u5f53\u6d89\u53ca\u5230\u4fdd\u5bc6\u95ee\u9898\u65f6\uff0c\u6211\u4eec\u4ece\u4e0d\u4f1a\u6389\u4ee5\u8f7b\u5fc3\u3002\u6211\u4eec\u62e5\u6709\u5b8c\u5584\u7684\u6587\u6863\u548c\u5b8c\u5168\u53ef\u8ffd\u6eaf\u7684\u4fe1\u606f\u5b89\u5168\u653f\u7b56\u3001\u68c0\u67e5\u8868\u548c\u8d28\u91cf\u8bb0\u5f55\u3002\u540c\u65f6\uff0c\u6211\u4eec\u7684\u64cd\u4f5c\u6d41\u7a0b\u4e0e <b>ISO 27001<\/b> \u63d0\u4f9b\u7684\u6700\u4f73\u5b9e\u8df5\u65b9\u5f0f\u4fdd\u6301\u4e00\u81f4\uff0c\u4fdd\u969c\u5ba2\u6237\u4fe1\u606f\u7684\u5b89\u5168\u3002\n<\/p>\n<p><span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e6%8a%80%e6%9c%af%e5%ae%89%e5%85%a8\/\"><u>\u4e86\u89e3\u66f4\u591a<\/u><\/a><\/span>\u5173\u4e8eCSOFT\u5982\u4f55\u4f18\u5148\u8003\u8651\u6570\u636e\u5b89\u5168\u7684\u4fe1\u606f\u3002\n<\/p>\n    [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.5.3&#8243; background_enable_color=&#8221;off&#8221; custom_padding=&#8221;0|0px|0px|0px|false|false&#8221; locked=&#8221;off&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; _builder_version=&#8221;4.5.3&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; custom_padding=&#8221;60px|0px|60px|0px&#8221; border_width_top=&#8221;1px&#8221; border_color_top=&#8221;#cccccc&#8221; global_module=&#8221;175789&#8243; saved_tabs=&#8221;all&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;3.25&#8243; custom_padding=&#8221;|||&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text _builder_version=&#8221;4.5.3&#8243; _module_preset=&#8221;default&#8221;]\n\n\n<h2>\u8d28\u91cf\u4fdd\u8bc1<\/h2>\n\n<p>\u901a\u8fc7\u6211\u4eec<span><a href=\"https:\/\/www.csoftintl.com\/technology\/\"><u>\u57fa\u4e8e\u4e91\u7684\u521b\u65b0\u6280\u672f<\/u><\/a><\/span>\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u63d0\u4f9b\u4e86\u4e00\u4e2a\u5728\u7ebf\u7ffb\u8bd1\u7ba1\u7406\u751f\u6001\u7cfb\u7edf\uff0c\u7cfb\u7edf\u4e2d\u5fc3\u4f4d\u7f6e\u5b9e\u65f6\u5229\u7528\u7ffb\u8bd1\u8bb0\u5fc6\u4ee5\u53ca\u672f\u8bed\u7ba1\u7406\u3002<\/p>\n\n<p>\u9ad8\u8d28\u91cf\u7684\u7ffb\u8bd1\u548c\u672c\u5730\u5316\u4e1a\u52a1\u5bf9\u653f\u5e9c\u673a\u6784\u6781\u4e3a\u91cd\u8981 - \u4e0d\u51c6\u786e\u7684\u7ffb\u8bd1\u4e0d\u4ec5\u4f1a\u5bfc\u81f4\u65f6\u95f4\u3001\u6210\u672c\u548c\u7cbe\u529b\u7684\u6d6a\u8d39\uff0c\u800c\u4e14\u8fd8\u4f1a\u5f71\u54cd\u60a3\u8005\u548c\u6d88\u8d39\u8005\u7684\u751f\u6d3b\u3002\u8fd9\u5c31\u662f\u4e3a\u4ec0\u4e48CSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u81f4\u529b\u4e8e\u786e\u4fdd\u6700\u9ad8\u8d28\u91cf\u7684\u7ffb\u8bd1\u670d\u52a1\u3002\u4e3a\u6b64\uff0c\u6211\u4eec\u8058\u8bf7\u81f3\u5c11\u67097\u5e74\u7ecf\u9a8c\u7684\u672c\u571f\u8bed\u8a00\u5b66\u5bb6\uff0c\u5e76\u4e14\u4e0d\u65ad\u62d3\u5c55\u6211\u4eec\u7684\u591a\u9886\u57df\u4e3b\u9898\u4e13\u5bb6\u7f51\u7edc\u3002\u6b64\u5916\uff0c\u6211\u4eec\u901a\u8fc7<span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e8%af%ad%e8%a8%80%e9%aa%8c%e8%af%81\/\"><u>\u8bed\u8a00\u9a8c\u8bc1<\/u><\/a><\/span>\u3001<span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/%e5%9b%9e%e8%af%91\/\"><u>\u56de\u8bd1<\/u><\/a><\/span>\u548c<span><a href=\"https:\/\/lifesciences.csoftintl.com\/zh-hans\/gestion-terminologica\/\"><u>\u672f\u8bed\u7ba1\u7406<\/u><\/a><\/span>\u4e0d\u65ad\u5b8c\u5584\u672c\u5730\u5316\u6700\u4f73\u5b9e\u8df5\uff0c\u5e2e\u52a9\u653f\u5e9c\u673a\u6784\u3001\u975e\u653f\u5e9c\u7ec4\u7ec7\u3001\u516c\u5171\u90e8\u95e8\u548c\u56fd\u9645\u7ec4\u7ec7\u63a5\u89e6\u4e0d\u540c\u6587\u5316\u80cc\u666f\u7684\u793e\u533a\u3002\u4e3a\u4e86\u786e\u4fdd\u9ad8\u8d28\u91cf\u7684\u6280\u672f\u7ffb\u8bd1\u89e3\u51b3\u65b9\u6848\uff0cCSOFT\u534e\u4e5f\u751f\u547d\u79d1\u5b66\u7684\u4e13\u4e1a\u6027\u5f97\u5230\u4e86<strong><b>ISO 17100:2015\u3001ISO 9001:2015<\/b><\/strong>\u548c<strong><b>ISO 13485:2016<\/b><\/strong>\u8ba4\u8bc1\u7684\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u652f\u6301\u3002\u540c\u65f6\uff0c\u6211\u4eec\u7684\u64cd\u4f5c\u6d41\u7a0b\u7b26\u5408<strong><b>ISO 27001<\/b><\/strong>\u7684\u6700\u4f73\u5b9e\u8df5\uff0c\u786e\u4fdd\u6211\u4eec\u7684\u5b9a\u5236\u5316\u89e3\u51b3\u65b9\u6848\u7b26\u5408\u5168\u7403\u76d1\u7ba1\u8981\u6c42\u3002\n<\/p>\n<p><span><a href=\"https:\/\/lifesciences.csoftintl.com\/translation-quality\/\"><u>\u9605\u8bfb\u66f4\u591a<\/u><\/a><\/span>\u5173\u4e8e\u6211\u4eec\u7684\u8d28\u91cf\u4fdd\u8bc1\u3002<\/p>\n\n\n    [\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; 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