Clarifying Process Verification vs. Process Validation In Med Device

By James Jardine

One of the most nebulous aspects of compliance for a medical device manufacturer is knowing whether a process should be verified or validated to ensure its conformity to regulatory requirements. High-level answers to medical manufacturers' process verification vs. process validation questions can be found in the Quality System Regulation (QSR) requirements outlined in 21 CFR Part 820, which is enforced by the U.S. Food and Drug Administration (FDA). However, many device makers have expressed concerns that the QSR does not specifically define the activities that require process validation and those that require process verification.

The answers to the following frequently asked questions provide background on the intent of the QSR and should shed light on the FDA's perspective of the verification vs. validation conundrum.