Description:
This Complaint Log (LOG-VIG-001) helps us track each complaint from receipt to closure, ensuring traceability, timely escalation, and consistent vigilance decisions.

• Assign and record the unique complaint ID COMYYYY-XXX.

• Capture the complaint Date and maintain the log up to date until closure.

• Link the log entry to the Complaint form (FORM-VIG-001) record.

• Support escalation to MDR vigilance using SOP-VIG-001 when needed.

• Enable trend monitoring for non-reportable events.

Your needs:

• Complaint log template

• Complaint log template for ISO 13485 and MDR compliance.

• Reduce missed follow-ups, improve traceability, and strengthen audit readiness.

Use this log whenever we open, update, or close a complaint to keep one controlled overview of status, owners, and escalations.

It supports consistent oversight. CHU is the team responsible for complaint handling; it matters because it centralizes ownership. Trend monitoring is ongoing review of non-reportable events; it matters because patterns can change benefit-risk.

• Register every complaint and keep the log current until closure.

• Maintain unique complaint identification COMYYYY-XXX.

• Ensure complaint receipt details are captured and updated when new information arrives.

• Escalate reportability evaluation using SOP-VIG-001 when applicable.

• Record decision outcomes to support CAPA linkage and closure review.

At Lexqara, we help you connect complaint logging, vigilance decision records, PMS trend inputs, and CAPA traceability into an inspection-ready workflow. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Request a short gap assessment.