Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
The Corrective and Preventive Action (CAPA) process is at the heart of your quality and compliance system. When properly implemented, CAPA resolves and prevents critical problems and also keeps you in compliance with FDA regulations. But year after year, lack of CAPA procedures and documentation make the list of top FDA 483 observations. The FDA closely monitors the CAPA process, which is why you need to have a handle on it as well.
CAPA Process Maturity
In previous blogs, we’ve discussed the idea of quality system maturity. Similar to the overall quality system, Life Sciences organizations can be at different stages in the maturity of their CAPA processes. Some are working to define CAPA processes and procedures for compliance, while others have streamlined CAPA processes that build product quality and proactively prevent defects. Many organizations are even taking CAPA a step further and using this required process to achieve business gains beyond their quality and compliance-specific goals.
Improving Your CAPA Process
No matter where you are in building a better CAPA process, our e?book, Leverage CAPA Best Practices to Build a Culture of Quality, will help you to improve it. In this e?book, we share 10 improvements to help you leverage your CAPA process to stay compliant, improve product quality, and to meet your broader business needs. This includes engaging CAPA to help build your organization’s Culture of Quality.
This e?book will help you to:
- Understand CAPA basics so you can build a reliable CAPA process.
- Recognize current CAPA challenges and trends.
- Build a compliant CAPA process to avoid 483s.
- Leverage the CAPA process to support and build market leadership.
What are your greatest CAPA process challenges and how will you improve your CAPA process this year? Please share your thoughts in the comments below.
Leverage CAPA Best Practices to Build a Culture of Quality
Download this free e-book from Pilgrim Quality Solutions, and learn how CAPA can benefit your organization.