EU GMP 计算机化系统定期评估

成慧潫

EU GMP附录2原文如下：
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.
其中几个词怎么理解请各位老师指导：
1.  the current range of functionality.指的是日常运行中，有没有按照验证的参数范围进行运行？
2. performance，有没有将工艺参数控制在要求范围内？
3. reliability，性能可靠性？安全可靠性？IT方面的系统稳定性？
4. validation status reports，本来就是要做定期评价才能有保持验证状态报告，报告怎么就变成评估的内容了？

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