计算机化系统进行定期评估,具体内容有哪些方面?
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计算机化系统进行定期评估,具体内容有哪些方面?

2025-12-12 13:34 识林-树苗     
2个回答

计算机化系统定期评估在实操层面建议分两部分进行,一块是对各部门分管的计算机化系统进行审查,另一块需建立对公司层面IT基础设施和服务器的定期评估要求。

具体也可以参照GMP指南6.3计算机化系统的生命周期

2025-12-15 09:26 Jyolo     

可参考EU gmp annex 11的相关要求,具体如下:

11. Periodic evaluation
Computerised systems should be periodically evaluated to confirm that they remain in a valid
state and are compliant with GMP. Such evaluations should include, where appropriate, the
current range of functionality, deviation records, incidents, problems, upgrade history,
performance, reliability, security and validation status reports.

2025-12-12 16:00 沐清风