定期评估和回顾式验证有什么区别

成慧潫

EU GMP Annex 15：Retrospective validation is no longer considered an acceptable approach

EU GMP Annex 11：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

What is the difference(s) between “Retrospective validation” and “Periodic evaluation”Periodic evaluation?

岁寒三友

目的不同

zysx01234

现在不叫回顾验证，只能允许定期评估，而年度评估是必不可少的

feignte

回顾验证是验证。针对刚有验证概念时，一些实际能够长期稳定生产但最开始没做过验证的产品，允许用历史数据来验证。现在这个基本上没用了。
定期评估，是验证和确认的延续，对系统始终处于验证状态的持续性进行确认。

915_雨

你试试把回顾验证叫定期评估算了