Corrective and preventive action (CAPA) is a good manufacturing practice (GMP) concept in which product failures are investigated to determine their root cause in an effort to eliminate occurrences of nonconformity (corrective action) and prevent similar occurrences from happening in the future (preventive action). Whereas a corrective action can be thought of as a reaction to a nonconformance, preventive action is a proactive approach aimed at preventing future occurrences of nonconformance before they happen.
CAPA software helps address these processes and should include the following capabilities:
CAPA involves:
*Source: pharmaceuticalonline.com
*Source: techiequality.com
The purpose of CAPA is to identify the root cause of product nonconformities or quality issues and implement the appropriate corrective and/or preventive measures to prevent their reoccurrence.
*Source: fda.gov
Medical device companies must have a compliant Corrective Action Preventive Action (CAPA) process in place to comply with FDA 21 CFR 820.100. Learn the essential elements of a CAPA system.