受法规约束的GMP和GDP环境下数据管理和完整性优良规范中英文.docVIP

PIC/S 受法规约束的GMP/GDP环境下数据管理和完整性优良规范（中英文） PIC/S GUIDANCE PIC/S指南 ?PIC/S：国际药品监查合作计划 GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS 受法规约束的GMP/GDP环境下数据管理和完整性优良规范 PIC/S August 2016 2016年8月 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. ? ? ? TABLE OF CONTENTS??目录1. Document history文件历史2. Introduction引言3. Purpose目的4. Scope范围5. Data governance system数据管理系统5.1 What is data governance什么是数据管理5.2 Data governance systems数据管理系统5.3 Risk management approach to data governance数据管理的风险管理方法5.4 Data criticality数据关键度5.5 Data risk数据风险5.6 Data governance system review数据管理体系审核6. Organisational influences on successful data integrity management公司对数据完整性管理成功与否的影响6.1 General概述6.2 Code of ethics and policies道德和方针准则6.3 Quality culture质量文化6.4 Modernising the Pharmaceutical Quality Management System药物质量管理体系现代化6.5 Regular management review of quality metrics质量尺度的定期管理评审6.6 Resource allocation资源配置6.7 Dealing with data integrity issues found internally内部发现的数据完整性问题处理7. General data integrity principles and enablers一般数据完整性原则和推进者8. Specific data integrity considerations for paper-based systems纸质系统特定数据完整性考虑8.1 Structure of QMS and control of blank forms/templates/recordsQMS结构和空白表格/模板/记录的控制8.2 Why is the control of records important?为什么记录的控制如此重要？8.3 Generation, distribution and control of template records模板式记录的产生、分发和控制8.4 Expectations for the generation, distribution and control of records产生、分发和控制记录的要求8.5 Use and control of records within production areas生产区域内记录的使用和控制8.6 Filling out records记录填写8.7 Making corrections on records记录更正8.8 Verification of records记录核查8.9 Maintaining records记录维护8.10 Direct print-outs from electronic systems从电子系统中直接打印出的记录8.11 True copies真实备份8.12 Limitations of remote review of summary reports远程审核报告摘要的局限性8.13 Document retention文件保存8.14 Disposal of original