Description:
This CAPA Log template gives us a single, controlled view of every CAPA so we can track progress, owners, deadlines, and closure decisions without losing evidence.

• Register each CAPA using a unique CAPAYYYY-XXX identifier.

• Capture source of issue (audit, complaint, PMS, supplier, NC product) for traceability.

• Record status across the CAPA phases (from initiation to closure).

• Assign responsible owner/pilot and due dates for each milestone.

• Link root-cause analysis outputs to the action plan.

• Track effectiveness evaluation evidence and acceptance criteria.

• Record Quality Manager review and final approval/signature at closure.

Your needs:

• CAPA log template

• CAPA log template for ISO 13485 and MDR compliance

• Reduce rework, control timelines, and improve audit readiness.

Use this log whenever a CAPA is opened, updated, or closed so we maintain an up-to-date management overview of corrective and preventive actions within our QMS.

It focuses on accountability. CAPA is the controlled process to correct issues and prevent recurrence. Effectiveness evaluation confirms actions worked against measurable criteria.

• Maintain an up-to-date CAPA status overview.

• Track owners, due dates, and overdue actions.

• Record root-cause completion and linked evidence.

• Document action implementation and supporting records.

• Capture effectiveness outcomes and conclusions.

• Confirm documented closure approval and archiving.

At Lexqara, we help implement CAPA workflows that connect audits, complaints, PMS signals, and risk management—supported by training and inspection-ready records. Visit our Resource Center [https://lexqara.com/resource-center] and Audit & Inspection Support [https://lexqara.com/services/audit-and-inspection-support]. ISO 13485 overview [https://www.iso.org/standard/59752.html]. Download the template or request a short gap assessment.

A well-run CAPA log improves visibility, strengthens management review inputs, and reduces repeat findings by keeping actions measurable and traceable.