07-01 Corrective & Preventative Action Procedure


This SOP describes and controls the complete CAPA procedure necessary to satisfy FDA requirements. It covers complaint evaluation (what is a complaint?), process nonconformities, MDR evaluation, trending, etc. A Visio flowchart clarifies this complex process (13 pages + 1 report form).

Webinar slides which explain the SOP and the context of the SOP are included. These could be used for training.

Browse this category: CAPA SOP GROUP