Current Good Manufacturing Practices for Medical Devices (CGMP) subpart J – Sec.820.100 Corrective and Preventive Action states; each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. Based on this requirement, Medical Device and Pharmaceutical companies have created a CAPA system to provide a uniform and consistent process to conduct and document external and internal problem investigations and subsequent corrective and preventive actions.

Business Excellence Professional Consulting (BEPC) provides a framework and a systematic methodology for identifying, documenting, analyzing, and preventing occurrence or recurrence of problems associated with products, processes, and/or systems.