It is essential that any FDA-regulated company have an effective CAPA system , but unless they drive the company to a confirmed solution to a quality issue, CAPA systems serve no purpose and they can waste resources. Companies are often at a loss as to what an effective CAPA system should look like, so they err by enforcing either too much control or not enough control.
At its core, an effective CAPA system should be a closed loop system, ensuring evaluation of quality input, implementation of...(read more)Image may be NSFW.
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