I have a question about validation vs. calibration of measuring equipment for a medical device company. A recent internal audit reported that we haven?t performed OQ/PQ on our vision inspection system for inspecting mechanical parts. This confuses me. This equipment is calibrated. I didn?t understand why measuring equipment that is calibrated also needs to have process validation. If process validation is required for measuring equipment such as a vision inspection system, is it required for all measurement equipment? Looking at 2 extremes: the vision inspection system and a digital caliper: Would process validation be required for both pieces of equipment after calibration has been performed?
Thank you much.
Thank you much.