Maintenance / 维护 2009 GPG Management of Engineering Standards / 工程标准管理 2016 GPG Operations ...
受到刚刚离职的前单位领导的委托，要研读一下 ISPE data integrity by design这本指南。手上只有英文版...
根据下列程序(应有)进行确认 • Data definition and mapping Processes • 数据界定和数据映射程序 • System design and development Processes • 系统设计和开发程序 • Good installation practices, checking wiring, grounding, segregation • 良好安装规范,线路、接地、隔离检查 • Good maintenance ...
Maintenance 维护 开羽 13 Appendix 1 – Example User Requirements 用户需求手册样例 Julia Specification 14 Appendix 2 – Sample Document: Number and 文件样例:热分布研究探头 鲁莽 Location of Mapping Sensors 数量和位置 15 Appendix 3 – Example Use of Measurement 测量不确定度使用样例 无名 Uncertainty ...
国际制药协会ISPE基础指南03卷.pdf,A GUIDE FOR NEW FACILITIES VOLUME 3: STERILE MANUFACTURING FACILITIES EXECUTIVE SUMMARY June 2000 A DOCUMENT DEVELOPED IN PARTNERSHIP BY: ISPE BASELINE® GUIDE STERILE MANUFACTURING FACILITIES JUNE 2000 2 ISPE BASELINE
根据下列程序（应有）进行确认 ∙Data definition and mapping Processes ∙数据界定和数据映射程序 ∙System design and development Processes ∙系统设计和开发程序 ∙Good installation practices, checking wiring, grounding, segregation ∙良好安装规范，线路、接地、隔离检查 ∙Good maintenance practices and...
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In this environment, information systems will capture experimental, study, and analytical data in addition to process information, and sophisticated information systems will be responsible for automating most PQS maintenance. Also, timelines will be adhered to as programmed; documents can be automatically...
A SaaS provider developing and maintaining a high-qualitysoftware offering to be sold in the regulated space should ensure that theirdevelopment and maintenance artifacts demonstrate the traceability of the verificationactivities against their specifications in whatever tool or format is used. 从一开始,...
Maintenance / 维护 2009 GPG Management of Engineering Standards / 工程标准管理 2016 GPG Operations ...