实验室计算机化系统PQ测试管理

The PQ Management of Computerized System in Laboratory

在制药企业,国内外各类审计特别关注对数据完整性的审查,特别是实验室仪器计算机化系统PQ是如何测试和管理的。通常情况下,供应商提供了IQ/OQ确认,企业需根据风险评估,进行PQ确认(如数据安全性方面的挑战性测试)。目前企业正常运行的实验室仪器,有单机版和服务器版,针对这两种仪器将如何进行计算机化系统的PQ测试开展讨论。

In the Pharmaceutical enterprise, domestic and foreign audits are particularly concerned with the review of data integrity, especially how to verify and manage the computerized systems PQ in laboratory. In general, vendors provide IQ/OQ, then companies need to conduct PQ based on risk assessments（such as challenging tests on data security）. At present, there are standalone and server versions of laboratory instruments, but how to do PQ of computerized system, this article will discuss about it.