Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we rely on validation for new fixtures and processes. Verification are stated in procedures as 100% inspection to verify that the device is being built according to our specifications. Validation are more time consuming and costly but is required to comply with the FDA standards and company standards we uphold to give our customers a safe medical device. Currently, Im working on validating an automated fixture for the production floor and it will require a complete IQ, OQ, PQ , preventative maintenance etc. The cost to have the fixture calibrated, along with getting lots for testing will be cost thousands of dollars. But the safety and reliability that we provide to our customers with a class III medical device requires that we spend that money to validate the fixture.