系统再验证/定期审查能否超过3年？

PERIODIC REVIEW

定期审查

Periodic Review (aka Validation Maintenance) refers to activities that areperformed to demonstrate a qualified/validated system is maintained in avalidated state. Qualified/validated systems shall be placed into a programwhich reviews the system to determine whether it continues to be maintained ina qualified state.

定期审查（也称为验证维护）是指为证明已确认/验证系统处于验证状态而执行的活动。已确认/验证的系统应纳入一个程序中，该程序审查系统以确定系统是否继续保持已确认状态。

Is periodic review synonymous with Validation Maintenance?

定期审查是否等同于验证维护？

Periodic review is a subset of Validation Maintenance, which includes allactivities that will maintain systems in a qualified/validated state (such asperiodic requalification and routine/continuous monitoring).

定期审查是验证维护的子集，验证维护包括将系统维护在已确认/验证状态的所有活动（如定期再确认和日常/持续监测）。

Does the periodic review guide imply no more than 3-year frequency? Can data be used to extend beyond 3 years?

定期审查频率是否不得超过 3 年？数据能否用于超过 3 年？

Periodic review frequencies depend on risk assessments and shall have anassociated rationale. A period beyond 3 years can be acceptable given appropriaterationale with Quality approval.

定期审查频率取决于风险评估，应有相关理由。如果提出适当的理由，并经质量批准，3 年以上的周期是可以接受的。

Regarding Periodic Review how do you define a low risk system?

关于定期审查，如何定义低风险系统？

Low risk systems are systems that will not impact product quality ifperiodic review is not performed. Risk categorization allows to triage systemsfor periodic review and are site/company specific.

低风险系统是如不进行定期审查，也不会影响产品质量的系统。风险分级可以用于系统定期审查，并且可以特定与不同工厂/公司。

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