MHRA-GxP-data-integrity-guide-March-数据完整性指南和定义.docxVIP

Medicines Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions GXP 数据完整性指南和定义 March 2018 目录 Background 背景 3 Introduction 概述 3 The principles of data integrity 数据完整性原则 4 Establishing data criticality and inherent integrity risk 建立数据关键性和内在完整性风险 5 Designing systems and processes to assure data integrity; creating the ‘right environment’. 设计系统和流程确保数据完整性，创建“正确环境” 7 Definition of terms and interpretation of requirements 术语定义和要求诠释 8 Data 数据 8 Raw data (synonymous with ‘source data’ which is defined in ICH GCP) 原始数据（与 ICH GCP 中定义的“源数据”为同义词） 9 Metadata 元数据 10 Data Integrity 数据完整性 10 Data Governance 数据管理 10 Data Lifecycle 数据生命周期 11 Recording and collection of data 数据记录和采集 11 Data transfer / migration 数据转移/迁移 12 Data Processing 数据处理 12 Excluding Data (not applicable to GPvP): 除外数据（不适用于GPvP） 13 Original record and true copy 原始记录和真实副本 13 11.1. Original record 原始记录 13 6.11.2. True copy 真实副本 14 Computerised system transactions: 计算机化系统处理 15 Audit Trail 审计追踪 15 Electronic signatures 电子签名 17 Data review and approval 数据审核和批准 18 Computerised system user access/system administrator roles 计算机化系统用户权限/ 系统管理员角色 19 Data retention 数据保存 20 Archive 归档 20 Backup 备份 21 File structure 文件结构 21 Validation – for intended purpose (GMP; See also Annex 11, 15) 根据既定用途进行验 证（参见附录 15 和GAMP5） 22 IT Suppliers and Service Providers (including Cloud providers and virtual service/platforms (also referred to as software as a service SaaS/platform as a service (PaaS) / infrastructure as a service (IaaS)). IT 供应商和服务提供商（包括云服务提供 商和虚拟服务/平台（也请参见 SAAS/PAAS/IAAS）） 22 Glossary 术语 24 References 参考文献 25 Background 背景 The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of