SEVEN Key Components for your Complaint Handling System

The Product Complaint Handing system defined in 21 CFR 820.198 (Complaint Files) requires procedures and processes for receiving, evaluating, investigating, remediating, documenting and reporting, record keeping and trending of product specific complaints. Procedures and processes must ensure timely and systematic processing by a formally designated unit by trained and qualified personnel. With consideration of these key components for procedures and processes, effective implementation and monitoring, a compliant Product Complaint Handling system can be implemented to avoid potential enforcement actions.