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欧盟GMP附录11中关于计算机化系统定期回顾的描述:
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。
定期回顾应当包括:功能范围、偏差记录、事件、问题、升级历史、性能、可靠性、安全性和验证状态报告。
the current range of functionality, deviation records, incidents, problems, upgrade history, performance, reliability, security and validation status reports
加粗的部分应该怎么理解比较合适?
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