The corrective and preventive action (CAPA) process is one of the most important elements within a medtech company’s quality management system (QMS). The goal of the CAPA system is to identify, address, and prevent systemic issues that could compromise product safety, regulatory compliance, and the overall operations of the business.

Despite its importance, however, a lot of companies struggle to implement a CAPA management system that’s both effective and efficient. Year after year, deficiencies in the CAPA process are a leading cause of Form 483 observations during U.S. Food and Drug Administration (FDA) inspections.

So, in this article I want to outline the five key components of a strong CAPA system and look at some of the common challenges medtech companies face with CAPA—and how to overcome them.

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