Corrective and Preventive Actions (CAPAs) are critical elements within a quality management system (QMS). 

Did you know that Redica Systems allows you to generate reports on 483 observations involving CAPAs? Find out by contacting us for a FREE 483 Observation Report.

483 observations specific topic

According to the FDA website, the “purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.” 

When an FDA investigator inspects a GMP site, they expect to see a robust CAPA process integrated within the QMS. Lack of an effective CAPA process can result in 483 observations and other enforcement actions.

Want to learn more about building a robust CAPA process? Here are some carefully curated articles on the topic: 

Let us show you the power we can put at your fingertips—request a tour today!

Redica Systems tour

Get a Demo

We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.

Request a Demo