内容如下: 1 Introduction 介绍 1.1 Rationale for GAMP 5 Second Edition GAMP 5 第二版的基本原理 1.2 New and Revised Material 新的和修订的内容 1.3 Purpose 目的 1.4 Scope 范围 1.5 Business Benefits 业务收益 1.6 Structure 结构 2 Key Concepts 关键概念 2.1 Overview 概述 2.2 Key Terms 关键术语 3 Life Cycle Approach 生命周期方法 3.1 Computerized System Life Cycle 计算机化系统生命周期 3.2 Specification and Verification 规范和确认 3.3 Computerized System Validation Framework 计算机化系统验证框架 3.4 Critical Thinking Through the Life Cycle 贯穿整个生命周期的批判性思维 4 Life Cycle Phases 生命周期阶段 4.1 Concept 概念阶段 4.2 Project 项目阶段 4.3 Operation 运行阶段 4.4 Retirement 退役阶段 5 Quality Risk Management 质量风险管理 5.1 Overview 概述 5.2 Science-Based Quality Risk Management 基于科学的质量风险管理 5.3 Quality Risk Management Process 质量风险管理流程 6 Regulated Company Activities 受监管公司的活动 6.1 Governance for Achieving Compliance 实现合规的治理 6.2 System-Specific Activities 特定于系统的活动 7 Supplier Activities 供应商活动 7.1 Supplier Products, Applications, and Services 供应商的产品、应用和服务 7.2 Supplier Good Practices 供应商良好规范 7.3 Quality Management System 质量管理体系 7.4 Requirements 要求 7.5 Supplier Quality Planning 供应商质量计划 7.7 Sub-Supplier Assessments 次级供应商评估 7.8 Specifications 标准 7.9 Design Reviews 设计审核 7.10 Software Production/Configuration 软件生产/配置 7.11 Testing 测试 7.12 Commercial Release 商业放行 7.13 User Documentation and Training 用户文件和培训 7.14 System Support and Maintenance During Operation 运行期间的系统支持和维护 7.15 System Replacement and Retirement 系统更换和停用 8 Efficiency Improvements 效率改进 8.1 Establishing Verifiable and Objective User Requirements 建立可验证和客观的用户需求 8.2 Making Risk-Based Decisions 作出基于风险的决策 8.3 Leveraging Supplier Input 利用供应商的意见 8.4 Leveraging Existing Information 利用现有信息 8.5 Using Efficient Testing Practices 使用高效的测试规范 8.6 Employing a Well-Managed Handover Process 采用管理良好的移交流程 8.7 Managing Changes Efficiently 高效管理变更 8.8 Anticipating Data Archiving and Migration Needs 预设数据归档和迁移需求 8.9 Using Tools and Automation 使用工具和自动化 Management Appendices 管理附录 9 Appendix M1 – Validation Planning 附录 M1 – 验证计划 10 Appendix M2 – Supplier Assessment 附录M2 – 供应商评估 11 Appendix M3 – Science-Based Quality Risk Management 附录M3 – 基于科学的质量风险管理 12 Appendix M4 – Categories of Software and Hardware 附录M4 – 软件和硬件的类别 13 Appendix M5 – Design Review and Traceability 附录M5 – 设计审查和可追溯性 14 Appendix M6 – Supplier Quality Planning 附录 M6 – 供应商质量计划 15 Appendix M7 – Validation Reporting 附录 M7 – 验证报告 16 Appendix M8 – Project Change and Configuration Management 附录 M8 – 项目变更和配置管理 17 Appendix M9 – Documentation and Information Management 附录 M9 – 文件和信息管理 18 Appendix M10 – System Retirement 附录 M10 – 系统停用 19 Appendix M11 – IT Infrastructure 附录 M11 – IT基础设施 20 Appendix M12 – Critical Thinking 附录M12 – 批判性思维 Development Appendices 开发附录 21 Appendix D1 – Specifying Requirements 附录 D1 – 设定需求 22 Appendix D2 (Retired) 附录 D2(已停用) 23 Appendix D3 – Configuration and Design 附录 D3 – 配置和设计 24 Appendix D4 – Management, Development, and Review of Software 附录 D4 – 软件的管理、开发和审查 25 Appendix D5 – Testing of Computerized Systems 附录D5 – 计算机化系统的测试 26 Appendix D6 – System Descriptions 附录 D6 – 系统说明 27 Appendix D7 – Data Migration 附录 D7 – 数据迁移 28 Appendix D8 – Agile Software Development 附录 D8 – 敏捷软件开发 29 Appendix D9 – Software Tools 附录 D9 – 软件工具 30 Appendix D10 – Distributed Ledger Systems (Blockchain) 附录D10 – 分布式账本系统(区块链) 31 Appendix D11 – Artificial Intelligence and Machine Learning (AI/ML) 附录 D11 – 人工智能和机器学习 (AI/ML) Operation Appendices 运行附录 32 Appendix O – Introduction to Operation Appendices 附录 O – 操作附录简介 33 Appendix O1 – Handover 附录O1 -移交 34 Appendix O2 – Establishing and Managing Support Services 附录 O2 – 建立和管理支持服务 35 Appendix O3 – System Monitoring 附录 O3 – 系统监测 36 Appendix O4 – Incident Management and Problem Management 附录 O4 – 事件管理和问题管理 37 Appendix O5 – Corrective and Preventive Action 附录O5 – 纠正和预防措施 38 Appendix O6 – Operational Change and Configuration Management 附录 O6 – 操作变更和配置管理 39 Appendix O7 (Retired) 附录O7(已停用) 40 Appendix O8 – Periodic Review 附录O8 – 定期审查 41 Appendix O9 – Backup and Restore 附录 O9 – 备份和还原 42 Appendix O10 – Business Continuity Management 附录 O10 – 业务连续性管理 43 Appendix O11 – Security Management 附录 O11 – 安全管理 44 Appendix O12 – System Administration 附录 O12 – 系统管理 45 Appendix O13 – Archiving and Retrieval 附录 O13 – 归档和检索 Special Interest Topics Appendices 特殊主题附录 46 Appendix S1 – Alignment with ASTM E2500 附录 S1 – 与 ASTM E2500 的一致性 47 Appendix S2 – Electronic Production Records 附录 S2 – 电子生产记录 48 Appendix S3 – End User Applications Including Spreadsheets 附录 S3 – 包括电子表格在内的最终用户应用程序 49 Appendix S4 – Patch and Update Management 附录 S4 – 补丁和更新管理 50 Appendix S5 (Retired) 附录 S5(已停用) 51 Appendix S6 – Organizational Change 附录S6 – 组织变更 General Appendices 通用附录 52 Appendix G1 – References 附录G1 – 参考文献 53 Appendix G2 – Glossary 附录G2 – 词汇表 53.1 Acronyms and Abbreviations 缩写和缩略语 53.2 Definitions 定义 回复关键词“GAMP 5”下载该文件! ![]() ![]() ![]() 公众号 GMP办公室 ![]()
![]() ![]() |
|