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Effectiveness of CAPA


RR1

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Please can you give me some ideas on how you perform and document a CAPA effectiveness check. This was one of our non-conformances at a recent MHRA inspection.

 

Also to consider:

 

1. Does the QI remain OPEN until the effectiveness check has been done and proved to have worked, or can the QI be closed and the effectiveness checked scheduled as a separate task?

 

2. What happens if you have ++++++ effectiveness checks to do- what is the easiest way to do all of these?

 

Many thanks

 

 

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