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IQ, OQ, PQ and Validation Master List - Page 3

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  Post Number #17  
Old 25th July 2018, 02:18 PM

Total Posts: 10
Please Help! Re: IQ, OQ, PQ and Validation Master List

I also work for a contract manufacturer of medical devices and am in charge of validations. While I do have templates for the 3 main protocols as well as having a Validation Master List/Plan and have a question regarding such. During a previous customer audit we were issued a CAPA for not having our VML controlled. I have done a lot of research on this on both the FDA and GHTF websites and I do not see anywhere that states that this document is actually required let alone needing to be controlled. I agree it is a good idea to have one but since, during the process of performing validations, this will be updated quite frequently, thus requiring a revision update as well. I call this a living document and therefore it is not controlled, only the form itself would be. Any input on this would be greatly appreciated.

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