WHO 数据完整性指南-2021（中英文对照）02版.pdfVIP

WHO 技术报告No.1033 附录4 数据完整性指南-2021 GMP 办公室翻译组翻译 Annex 4 附录4 Guideline on data integrity 数据完整性指南 This document replaces the WHOGuidance on good data and record management practices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1). 本文件取代了《WHO 良好数据和记录管理规范指南》(WHO 技术报告系列，No. 996, 2016 附件5 ，)(1)。 1. Introduction and background 137 介绍和背景 2. Scope 137 范围 3. Glossary 138 术语 4. Data governance 140 数据治理 5. Quality risk management 144 质量风险管理 6. Management review 145 管理评审 7. Outsourcing 146 外包 8. Training 146 培训 9. Data, data transfer and data processing 147 数据，数据转移和数据处理 10. Good documentation practices 148 良好文件记录规范 11. Computerized systems 149 计算机化系统 12. Data review and approval 152 数据审核和批准 13. Corrective and preventive actions 152 纠正和预防措施 References 153 参考文献 Further reading 153 拓展阅读 Appendix 1 Examples in data integrity management 155 附录1 数据完整性管理示例 1 / 31 WHO 技术报告No.1033 附录4 数据完整性指南-2021 GMP 办公室翻译组翻译 1. Introduction and background 介绍和背景 1.1. In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP) (2), good clinical practice (GCP), good laboratory practice (GLP) and Good Trade and Distribution Practices (GTDP) have been increasing. The poss