PI041-1 10August2016 翻 译 : 朗 脉 S h a w n H s u 翻 译 仅 作 为 参 考 引 用 时 , 应 使 用 P I C / S 官 网 的 原 文 2/87 TABLEOFCONTENTS 目录 1DOCUMENTHISTORY/文件历史...7 2INTRODUCTION/简介...
4234 PICS 数据完整性 20210701 中英文1.pdf,PIC/S GUIDANCE PI 041-1 Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments 202107 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 1 July
PIC/S GUIDANCE PI 041-1 Good Practices For Data Management And Integrity In Regulated GMP/GDP Environments 202107 PICS GMP/GDP 环境下数据完整性指南 20210701 译文仅供参考 页 1 / 84 PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 041-1 1 July 2021 PIC/S ...
PI-041-1( draft 3) 5 / 69 2018 年11 月30 日 systems for potential vulnerabilities and take steps to design and implement good data governance practices to ensure data integrity is maintained. 数据管理和完整性优良规范的职责由接受检查的生产商或销售商承担。他们负有全部职责和义务来评估其 数...
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME (PIC/S) 制药检查合作组织 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATEDGMP/GDP ENVIRONMENTS GMP/GDP 环境下数据管理和完整性良好规范 DRAFT PIC/S GUIDANCE (draft 2 ) 指南(草案第二稿) PI041-1 10 August ...
响应12.2Indicatorsofimprovement改善指标13.Definitions定义14.Revisionhistory版本历史DOCUMENTHISTORY文件历史Draft1ofPI041-1presentedtothePIC/SCommitteeatitsmeetinginManchester4-5July2016曼彻斯特会议期间PI041-1草案提交给PIC/S委员会2016年7月4-5日ConsultationofPIC/SParticipatingAuthoritiesonpublicationoftheGood...
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