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

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installation qualification (iq), iso 13485 - medical device qms, operational qualification (oq), performance qualification (pq), procedures (general), sterile packaging, sterility and sterilization techniques, master lists (general), validation of machines equipment processes design etc., protocols (pharmaceutical term), master validation plan (mvp), medical devices
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  Post Number #17  
Old 25th July 2018, 02:18 PM
bcoolnow

 
 
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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