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Optimizing CAPAs in the Medical Device Industry

cover of white paper

The corrective actions and preventive actions process, simply referred to as the CAPA process, is one of the backbones of any QMS. How a medical device firm utilizes the CAPA process can be the difference between a highly successful operation or an operation that has systemic issues and is bogged down with inefficiencies. This white paper from EMMA International – an associate member of AdvaMed – explores how to best utilize CAPAs in the medical device industry including best practices, common pitfalls, and how to avoid “death by CAPA”. This paper also discusses the purpose and basic principles of CAPAs, as well as how the process has developed over time.

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