By Mark Durivage, Quality Systems Compliance LLC

Published in: Outsourced Pharma

Published on: February 5, 2020

Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system. Oftentimes, organizations do not fully document the CAPA phases and confuse verification of implementation and verification of implantation activities. This article will look at some of the regulations governing CAPAs and discuss the elements of 10 phases of a CAPA investigation that will help organizations ensure their CAPA processes are destined to succeed.

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