7 Steps To Ensure CAPA Success

By James Jardine

Product development in the life sciences is a multimillion-dollar process. The price of a mistake can be similarly staggering. With this level of money on the line, good corrective action/preventive action (CAPA) processes are essential.

Accurate and complete documentation of the CAPA process is essential for companies in meeting the regulatory requirements for a quality management system (QMS) as set out by the FDA, the International Organization for Standardization (ISO), and many others. Proper CAPA documentation shows that a manufacturer’s quality system is effective. It also demonstrates that production staff can quickly identify issues and implement corrective and preventive measures.

In this blog we give a general overview of the seven steps companies need to take to successfully complete and document CAPA.