Best Practices and FDA QSR Mandate
Establishing a corrective and preventive action (CAPA) system is a quality system requirement for Medical Device firms marketing products in the United States. Although the FDA has always expected regulated industries to perform corrective and preventive actions, establishing a unified CAPA system makes good business sense. The first and most important step in creating any system is to include all regulatory requirements in the firm’s standard operating procedures (SOPs). The following are seven key elements from 21 CFR 820.100 (Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.) This should be included in a firm’s SOPs: To get a handle on the CAPA system is a company wide effort. The following elements will provide what each company should do to create, maintain and leverage a sound CAPA platform.