I have just been appointed validation manager of our site for Facilities, Utilities and Equipment.
We are under close scrutiny since we are a medical device manufacturer but I want to make sure we are still doing the right things and not just what we hired our paid Ex FDA consultant to tell us to do. From my understanding most of the FDAs understanding of validation is taking it from the Bulk Manufacture side. Meaning pharma. We build electromaechanical devices and test them before they leave. Does this truly warrant a (IQ, OQ,PQ) validation if you are using software designed for the equipment or for the testing to perform functional test?
To me and my engineering background we need to establish that we have installed the equipment properly that is used to test the devices and that our software is adequate to perform its desired function. I don’t really understand how a PQ comes into play if you have an operator walking through instructions repeatidly on an electromaechanical device? How do you have variation?