√ 01 Anwarul 基于ISPE GAMP5的计算机化系统验证生命周期实施.pdf

IMPLEMENTATION OF CSV LIFECYCLE GOOD IMPLEMENTATION OF COMPUTERIZED SYSTEM VALIDATION BASED ON GAMP 5 基于GAMP5的计算机化系统验证的良好实施 BEIJ ING, 17 SEPTEMBER, 2020 ANWA RUL HA QUE, B SC, PGDIPEM, M SC MAN A GIN G DIRECTOR , AN SURON CON SULTAN CY LIMITED CONTENT 内容 • Regulation and Guidance pertaining to CSV 与CSV有关的法规和指南 • EU/ US-FDA/PIC/S • Good management and implementation practices throughout the lifecycle of computerized system 计算机化系统全生命周期的良好管理和实践 • Good management of construction and implementation of computerized system project 计算机化系统项目的构建 和实施的良好管理 • Supplier management, audit and points to consider供应商管理，审核和需要考虑的关键点 • Management documents structure of computerized system计算机化系统的管理文件结构 • Good practices of change control of computerized system计算机化系统变更控制的良好实践 • Periodic review and re-validation implementation of Computerized system计算机化系统的定期回顾和再验证 • Good management and implementation of electronic records and electronic signatures in computerized systems计算 机化系统的电子记录和电子签名的良好管理 CONTENT 内容 • (continued继续) • Good management and implementation of computerized system safety control计算机化系统安 全控制的良好管理和实施 • Computerized system emergency plan management and good implementation计算机化系统应 急计划管理和良好实施 • Calibration and maintenance of computerized system 计算机化系统的校准和维护 REGULATION AND GUIDANCE FOR COMPUTERISED SYSTEM VALIDATION – EUROPEAN UNION 计算机化系统验证的法规和指南-欧盟 EC COUNCIL  DIRECTIVE 93/42/EEC 欧盟理事会指令93/42/EEC ANNEX I ESSENTIAL REQUIREMENTS 附录I 基本要求 12. 1a For devices which  incorporate software or which  are medical software in  themselves, the software must  be validated according to the  state of the art taking into  account the principles of  development life cycle, risk management, validation and  verification.对于医疗器械包含软件或者医疗软件本身，这种软件的验证必须按照 当前最新水平的要求，包括考虑生命周期开发，风险管理，验证和验证的原则 EudraLexVolume 4  Good Manufacturing Practic