Closing the Loop: How CAPA Should Tie Back to Validation Risk Assessments Closing the Loop: Linking CAPA to Validation Risk Assessments in Pharma In pharmaceutical quality systems, Corrective and Preventive Action (CAPA) is not just a documentation exercise. When implemented properly, CAPA becomes a dynamic mechanism that continuously improves processes, systems, and controls — especially in the context of validation. Yet, in many GMP facilities, a major disconnect remains: CAPA records are often treated in isolation, with little or no integration back into risk assessments conducted during validation. This weakens the feedback loop, opens regulatory gaps, and undermines continual improvement….