Posts tagged "CAPA"

Closed System LOOP FDA Recommended CAPA Methodology

October 11th, 2015 Posted by 510(k), FDA, Medical Device Directive 93/42/EEC, Standards and Regulations 0 thoughts on “Closed System LOOP FDA Recommended CAPA Methodology”

In this paper we are going to examine the quality of the event management process, and in particular the CAPA, referred to as corrective and preventive action.
As we think about the quality management systems (QMS), and their different components, certainly quality event management is one of the most important.
Additionally, as we look at the quality event management system more specifically, we see that it may be broken up into primary components:
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