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, more than 450 issues were identified in CAPA systems used by medical device companies. To have an FDA-compliant QMS system required the capability to capture, examine, validate, manage, and recall closed-loop processes.