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Audit Question


When facing an audit for software, does the FDA check the quality assurance documents /quality policy of the company too?
OR does it only check for validation documents like VMP, IQP.,OQP,etc?

Yes. It checks mainly MPP, VMP and the Risk Assessment Documents. So, all QA, Validation documenst will be checked based on risk assesment

SQA , Validation and Risk Assessment are the three pillars for the Audit