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CDRH Urges Firms To Close Loop On CAPAs, Create Filters To Weed Out Poor Quality Data

This article was originally published in The Silver Sheet

Executive Summary

Applying a closed-loop approach to corrective and preventive action activities is one of the best ways to ensure device quality and gather useful data, FDA says. Manufacturers often fail to ensure that they complete the CAPA loop, leading to corrective and preventive actions that might be open for years, or product fixes that don’t work and complicate matters further by presenting the firms with a whole new set of challenges. And, “if an FDA investigator comes to your doorstep, he or she will look at what type of data sources you are including in your CAPA system. The investigator will try to verify how you are handling that data,” CDRH Quality System Specialist Jay Jariwala says. He also advises firms to make sure enough quality data is being passed along to their CAPA systems. “Never be afraid to feed your CAPA system. Not feeding it is the worst thing you can do,” Jariwala says.

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