The Value of an Effective and Efficient CAPA System

During the establishment of a CAPA System it is extremely important to ensure this critical Quality System is both suitable and effective for your organization. Suitable means that it is appropriate for your organization and compliant to the applicable regulations. Effective means that it works, as designed, and you get results. Also, because you run a business, your CAPA System must be efficient. You cannot waste resources and opportunity. The PathWise CAPA System provides the necessary process improvement to better execute the work content required of running a CAPA System and executing CAPA projects and enables this work to be conducted in an extremely efficient manner. Within all work process there exist three variables. 1. Work Content--The work necessary to execute CAPA (System and Projects) 2. Resources--The resources required to execute CAPA effectively 3. Time-- The time it takes your resources to execute CAPA (System and Projects)

Implementing the PathWise CAPA System will enable your organization to improve your Quality Management System and establish a means to effectively repair and improve all other elements within your system. The PathWise CAPA System establishes priorities in terms of addressing: Issues of High Severity (Risk Management) / Recall Avoidance Issues arising from Special Cause Variation (Process Control) / Scrap, Downtime, etc. Opportunity arising from Common Cause Variation (Process Improvement) / Yield The PathWise CAPA System will provide your organization with a Return On Investment for years to come.

Compliant, Effective, Efficient.

www.pathwise.com 866.580.PATH

Value of a Compliant CAPA System

As an organization operating within a regulated environment it is extremely important to ensure this critical Quality System element is suitable and effective for your organization.

Compliant Satisfies the regulations or requirements. Effective The system works, as designed, and you get results. Efficient work processes are streamlined and require minimal resources necessary for execution.

The FDA expects an organization to be capable of identifying relevant issues and repairing them in such a way so they will not reoccur. The expectation is that this is done through a Corrective and Preventive Actions element within an organizations Quality Management System. Without a compliant and effective CAPA System, it is clear the FDA quickly loses confidence in the organization and tends to quickly escalate the regulatory response beyond issuing 483 observations. A compliant and effective CAPA System can make the difference between assuring the FDA your organization is in control and capable of repairing itself or causing the FDA to place your organization in a higher risk category by issuing a Warning Letter to your Company. The PathWise CAPA System ensures control by addressing: Issues of High Severity (Risk Management) as a priority Issues arising from Special Cause Variation (Process Control) as a priority Effective Execution of CAPA (System and Projects) to prevent the recurrence of issues The PathWise CAPA System will provide confidence to the FDA that you are in control.

Compliant, Effective, Efficient.

www.pathwise.com 866.580.PATH