Does Your Medical Device Process Require Revalidation?
When you buy a new car you don’t expect it to run smoothly forever. Likewise, despite your diligence and best efforts, glitches will occur and process refinements will be made. Even new or modified processes falter after implementation. Thus, it’s important to remember that process validation is never complete for long. Process performance must be monitored and maintained over time to ensure consistent performance and full or partial revalidation of IQ, OQ, and PQ is simply part of the ongoing […]
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