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ROI CalculatorComplaint Handling is the controlled process to receive, document, evaluate, investigate, and close product complaints, with decisions and evidence that support regulatory reporting and CAPA.
For drugs, FDA 21 CFR 211.198 requires written procedures for handling all written and oral complaints, including quality unit review and investigation decisions with records.
For medical devices, 21 CFR 820.198 requires complaint files, evaluation and investigation (or documented rationale when not investigated), and linkage to corrective action when needed.
Example: A customer reports a leaking sterile pouch. The complaint is logged, risk is assessed, investigation is performed, affected lots are identified, and CAPA plus any required reporting is triggered, all with traceable records.
