浅谈计算机设备验证.pptVIP

* 设备验证 2008年11月 * * 第一页，共二十一页。 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。 FDA Guidelines on General Principles of Process Validation, May 1987. Documents 文件 * * 第二页，共二十一页。 Operational运行确认 Qualification Installation 安装确认 Qualification Design Qualification设计确认 Sequence of documents文件建立次序 Specification Qualification 标准确认 - URS 用户需求 - Specifications System 设计基础文件