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| A poorly maintained paper-based CAPA process may contribute to FDA violations. |
by Cindy Fazzi
Editor, MasterControl Insider
In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.
Some organizations think of CAPA only after quality issues have emerged. Others have CAPA systems in place but they are inadequate. This is evident in the case of a medical device firm, which received an FDA warning letter. Among other things, the agency said, “your CAPA implementation is inadequate in that you do not trend component failures” (1).
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