Kymanox® performed a gap assessment of Quality Management System (QMS) against 21 CFR Part 4. Ten Corrective and Preventative Actions (CAPAs) and their corresponding deviations were also reviewed for compliance to 21 CFR Part 4 as well as local procedures.

Challenge

Assessing CAPAs and their corresponding deviations for compliance.

Solution

Kymanox reviewed CAPAs to assess metrics such as on-time completion, number of extensions, effectiveness check pass rate, and more.

Results

Kymanox provided a preliminary report to this client of the gap assessment findings with recommendations and discussed with the CAPA process owner. Kymanox is continuing to review additional CAPAs to assess metrics and report these metrics to the client as the assessments are completed.