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Auditing "process validation" process


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Dear All,

Just want to check with your experience regarding conducting (internal/external) audit on the process validation process. With IOT and many processes being software managed, there is a huge amount of data being generated, in particular during process validation, with very limited time, how can internal audit check against the process validation and to identify issues from the mountain of data. Your suggestions and experience sharing is appreciated.
You raise a good point, frequently there isn't time to examine all the data generated in a validation. I would start with checking the obvious things, does the protocol or plan clearly lay out the validation process and is this then followed; does the report match the protocol, was everything signed in the date correct order, look at deviations, calibrations, etc. Then take a sample of the data, follow through one OQ run in detail, then one PQ batch. When time is limited, I would prefer to take a sample of data from 2 or 3 different validations, than try to follow one completely.


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I wouldn't want the internal audit team being my quality assurance for process validation team. I would want my internal audit team just to ensure that the approach is compliant and the process was executed as planned. Agree with chris1price that the internal audit would just do a sampling of several validations to assess compliance.

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