The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.

From the perspective of regulatory agencies like the U.S. Food and Drug Administration (FDA), CAPA is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Since more than half of Form 483 observations and warning letters cite CAPA deficiencies, it is evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections. In recent years the FDA has been promoting the adoption of closed loop CAPA systems where CAPA is the tool that drives reports and keeps management informed. Continue reading →