Closed System LOOP FDA Recommended CAPA Methodology

Rami.Azulay October 11th, 2015 Posted by Rami Azulay( ) 510(k), FDA, Medical Device Directive 93/42/EEC, Standards and Regulations

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:
Read More.


Start Your Free Trial Now


 


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

Tags:
Orcanos

Contact

8 Tozeret Ha'aretz Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com

Copyright © Orcanos, All rights reserved. | Privacy policy | Terms of use