CAPA (Corrective Action Preventive Action) Software

To manage the quality of any system or organization CAPA is required. Corrective Action and Preventive Action (CAPA) Software helps in addressing and improving the real-time problems of the Pharmaceutical, Biotechnology and Life Science industries, ensuring that each identified risk and problem addressed completely in compliance with 21 CFR PART 11, EU Annexure 11 and other regulatory and process standard requirements. As the name mentioned, a corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.

Corrective Action Preventive Action (CAPA) is a procedure which inspects and solves glitches, recognizes causes, takes corrective action and prevents recurrence of the origin causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. The determination to use the corrective and preventive action is to collect information, analyze information, identify & investigate product and quality problems by initiating appropriate and effective corrective and/or preventive action to prevent their recurrence. Basically, CAPA Software works on two principles, first goal is Root Cause Analysis (RCA) which is to find the root cause, base event or error that lead the problem and to take action directed at the root cause or error, and second goal is of Preventive Action (PA) is to inform an organization and prevent the problem from returning in other facilities lines or products. Essential factors to deal with product and quality problems, preventing their recurrence, and preventing or minimizing device failures, are verification or confirming corrective and preventive actions, communicating corrective and preventive action activities to responsible people, providing relevant information for management review, and documentation of the mentioned activities. Implementation of CAPA Software is required to identify the root cause of failure which is a key principle of any effective Quality Management System. When an issue arises, it is often just a symptom of the real problem like a disease, symptoms can be treated but digging out why the symptom has ben raised is the true motive for implementing CAPA. Failure to implement an effective Corrective Action Preventive Action process is a defilement of FDA regulations defining Good Manufacturing Practice (GMP). The whole process can be done after initiating the CAPA followed by defining the problem then cause investigation along with finding a solution (Action Plan) after that verification/validation and the implementation closing the CAPA after final step which is effectiveness check. CAPA Software implementation results in reduction in quality issues, reduction in the severity of issues, more preventive actions over time, better designed products/processes, improved customer satisfaction and better business results.

Leave a Reply

Your email address will not be published. Required fields are marked *