Article | February 23, 2023

Do You Have an FDA Audit Process in Place?

By David Butcher, MasterControl

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If the U.S. Food and Drug Administration (FDA) called tomorrow to schedule a visit to your facility, would you panic, or would it be business as usual because you know you're prepared? FDA audits can be stressful, and failing one can have significant consequences. The FDA inspection process typically involves observing employee activities, interviewing employees, reviewing records, and looking at documented procedures and requirements to assess how they all fit together in the quality system.

Learn about audit management software and how to maintain a state of FDA audit process readiness.

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