In 2015 there were over 450 issues found with the CAPA systems for medical device companies. To have an FDA-compliant QMS system required the ability to capture, review, approve, control, and retrieve closed-loop processes.
In 2015, there were over 450 issues found with CAPA systems used by medical device companies. To meet FDA requirements for a compliant QMS system, it was necessary to have the ability to capture, review, approve, control, and retrieve closed-loop processes.