EQUIPMENT VALIDATION IS NOT PROCESS VALIDATION

Posted on June 11, 2014

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...