Does your CAPA process need help?
In 2023 there were 336 483s written toward the Devices industry on the Corrective and Preventive Action (CAPA) system. The focus of these was on procedures not adequately established as well as inadequate documentation of activities (corrective and preventive) by Device firms. These are foundational requirements outlined in CFR 820.100 and ISO 13485 for CAPA systems and …