MHRA数据完整性指南2018(中英文)VIP免费

MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018 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 MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018 目录 1. Background 背景 .................................................................................................................... 3 2. Introduction 概述 .................................................................................................................... 3 3. The principles of data integrity 数据完整性原则 ...................................................................... 4 4. Establishing data criticality and inherent integrity risk 建立数据关键性和内在完整性风险 ....... 5 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 6. Definition of terms and interpretation of requirements 术语定义和要求诠释 ............................ 8 6.1. Data 数据 ..................................................................................................................... 8 6.2. 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 6.3. Metadata 元数据 ........................................................................................................ 10 6.4. Data Integrity 数据完整性 ........................................................................................... 10 6.5. Data Governance 数据管理 ........................................................................................ 10 6.6. Data Lifecycle 数据生命周期 .................