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PDA数据完整性行为守则要素中英对照版
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tegrity数据完整性目前已经成为全球卫生机构与制药行业所关注的重点。尽管不是一个新的问题,近期在很多卫生当局的执法行动例如警告信、进口警报、产品扣留,以及暂时取消或撤销上市许可中都非常关注数据完整性的问题。数据完整性可能由于缺乏法规要求意识、员工错误、无法核实数据准确性,软件或系统故障,或电子数据处理配置问题,或员工渎职行为导致。为了全面解决数据完整性问题,注射剂协会PDA正在开发一套面向行业的涵盖PDA技术报告、PDA培训程序、数据完整性研讨会,以及考虑要点文件的工具来解决这一严重问题。本文件代表注射剂协会PDA的观点,公司可自愿采用行为守则来确保数据完整性。HowtoUsethisDocume
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