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. 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. Food and Drug Administration (FDA), CAPA is perceived 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. The regulatory perspectiveįrom the standpoint of regulatory agencies like the U.S. The CAPA process requires critical thinking and an effective determination of the exact questions that need to be asked in order to come up with proper solutions. The second core facet of CAPA, one where more organizational control can be demonstrated, is process.

If personnel do not have a prior track record with CAPA, this may be an area where an organization has less control over CAPA activities. The first component is the experience, expertise, and wisdom of the personnel involved with conducting CAPA processes. At its most fundamental level, there are just two conceptual ingredients that make up a CAPA system. Some organizations are suffering from “death by CAPA”–their companies are being strangled because too many elements are included in their CAPA systems. For organizations in regulatory environments, CAPA is an overarching umbrella–all control points flow through to the CAPA system. If CAPA efforts are not driving toward a solution they are nothing more than a waste of time and resources. The primary objective of a corrective and preventive action (CAPA) is a solution to the problem for which the CAPA was generated. CAPA systems will factor into survival of firms in regulated life sciences markets By James Jardine, MasterControl Inc.

Capa process steps