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1、2019/8/4,1,设备验证,2008年11月,2019/8/4,2,Validation验证,“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”. 建立一个文件化的证据,以提供一个高水准的保证体系,确保生产出的产品始终符合预定的标准和质量要求。
2、FDA Guidelines on General Principles of Process Validation, May 1987.,2019/8/4,3,Sequence of documents文件建立次序,Specification Qualification 标准确认 - URS 用户需求 - Specifications System,System Owner 系统使用者,Engineering C. 工程部,ACS C计算机工程师.,Mech. C.机械工程师,ACS C. / System Owner 计算机工程师/系统使用者,Mechanical C. / System
3、Owner 机械工程师/系统使用者,System Owner 系统使用者,2019/8/4,4,V Model Life Cycle,2019/8/4,5,Specifications标准,URS用户需求 project level 项目层面,2019/8/4,6,Design - Basic documents 基础设计文件,General system description 概括的系统描述,PFD流程图,Room data sheets Parameters 参数一览表,Traceability matrix矩阵图,2019/8/4,7,Design & Installation - A
4、CS/Software 设计及安装软件,Detailed system description 详细系统描述,Parameter list 参数清单,Alarm list 报警项目清单,PID,Instrument list仪表清单,Equipment list设备清单,Traceability matrix矩阵图,Traceability matrix矩阵图,2019/8/4,8,Design & Installation - ACS/Hardware 设计及安装硬件,Detailed system description 详细的系统描述,Parameter list 参数清单,Alarm
5、list 报警清单,PID,Instrument list 仪表清单,Equipment list 设备清单,Traceability matrix矩阵图,Traceability matrix矩阵图,2019/8/4,9,Design & Installation Mechanical 设计&安装机械部分,Detailed system description 详细的系统描述,Parameter list参数清单,Alarm list报警清单,PID,Instrument list仪表清单,Equipment list设备清单,Traceability matrix矩阵图,2019/8/4,
6、10,Testing - FAT software 测试FAT软件部分,Traceability matrix矩阵图,Application software应用软件,FAT测试文件,Software软件,2019/8/4,11,Testing - FAT hardware 测试FAT硬件部分,Traceability matrix矩阵图,Electrical panels仪表板,Test documents FAT测试文件,Hardware硬件,Instruments仪表,2019/8/4,12,Testing - FAT Equipment 测试FAT 设备部分,Traceability
7、matrix矩阵图,Equipment设备,Test documents FAT测试文件,Equipment设备,2019/8/4,13,Field installation verification 现场安装确认,Traceability matrix矩阵图,System installation系统安装,Design documents 设计文件,IO test protocol IO测试方案,Tightness test protocols 严密的测试方案,System系统,2019/8/4,14,Approval 1 批准,Software FAT report 软件的FAT报告,Ha
8、rdware FAT report 硬件的FAT报告,Equipment FAT report 设备FAT报告,Field installation verification report 现场安装报告,2019/8/4,15,Testing - SAT software 测试SAT 软件,Traceability matrix矩阵图,Application software应用软件,Test documents SAT SAT测试文件,Software软件,2019/8/4,16,Testing - SAT equipment 测试SAT 设备部分,Traceability matrix矩阵
9、图,Equipment设备,Test documents SAT SAT测试文件,Equipment设备,2019/8/4,17,Approval 2,Software SAT report 软件SAT报告,Equipment SAT report 设备SAT报告,2019/8/4,18,Systems,1 System = 1 PID,Example如: 1 air handling unit一个空调单元 1 clean steam generator一个清洁蒸汽发生器 3 holding tanks三个储罐,2019/8/4,19,Traceability 追溯性,2019/8/4,20,Criticality 关键,URS,Compares GXP with URS paragraphs 逐段比对URS与GXP符合性,Defines actions for Project and Owne 项目组和用户确定必要的行动r,Highlights SOP and DSD controls 简述SOP与系统描述中重点,
