CAPA systems are designed to simplify FDA regulatory requirements for corrective and preventative action processes.
Implementing CAPA in Quality Management Systems (QMS) simplifies the process of complying with FDA requirements. It provides a safeguard against regulatory risk by integrating with QMS systems for audits, non-conformances, and change control.
To ensure FDA compliance, manufacturers must ensure that their CAPA system can demonstrate the effectiveness of their quality system. A true CAPA system enables the identification of defects and problems as well as the implementation of effective and preventive actions.
A fundamental aspect of quality management is continuous improvement. A sound CAPA system ensures this by handling non-conformances quickly and efficiently, in addition to preventing future errors.
- A good CAPA system should be able to do the following:
Include CAPA procedures that address quality requirements - Identify non-conformances and facilitate data analysis focusing on the root causes of product quality concerns
- Enable visualization and reporting of quality performance analytics
- Integrate with compliance, audit, and training management systems
- Enable users to monitor trends for preventative action
- Facilitate the statistical analysis of failures and discrepancies
- Allow users to validate the success of corrective and preventive actions
Regardless of industry or the size of your company, you should implement CAPA software systems as part of your quality management system if you want to reduce business risks and improve quality levels.
CAPA programs are most effective when they are approached and utilized as proactive systems as opposed to reactive ones. The benefits of this approach include:
- Assurance that quality issues are resolved
- Reduced rework and scrap numbers
- Compliance requirements are met
- Reduced customer complaints
- A streamlined procedure for problem-solving
