Fact Sheet
5 Steps to a Reliable CAPA Process
Maintain compliance and achieve operational excellence in your corrective and preventive action process
Feb 07, 2023
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A strong CAPA program requires proper planning and organization. It sounds simple, but lack of CAPA process documentation is a frequent reason for FDA 483 citations, which can damage your brand reputation and even lead to a shutdown. Many details need to be documented prior to implementing a CAPA workflow including processes to be monitored, people to involve, potential failure modes, severity levels and actions to implement best practice CAPA.

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