What is a CAPA Process Owner?

CAPA Process Owners are professionals responsible for overseeing the Corrective and Preventive Action (CAPA) process within an organization, typically in highly regulated industries like pharmaceuticals or medical devices. They ensure that any identified nonconformities or issues are properly investigated, root causes are determined, and effective actions are implemented to prevent recurrence. CAPA Process Owners also monitor the effectiveness of these actions, maintain documentation, and ensure compliance with regulatory requirements. Their role is crucial in maintaining product quality and organizational compliance.