The complaint or product surveillance
system is THE quality system. This complaint system must demonstrate that it
is sensitive to product performance. Complaint handling and reporting
are critical to the manufacturer in terms of product liability and
regulatory actions, including recall. cGxP can assist in the following ways:
Design/Review Complaint Handling Systems
Medical Device Reporting systems (MDR regulations)
Design/Review Failure investigation methods and documentation.
Develop and implement trending systems for manufacturing and field
Company wide systems for collection and analysis of complaint, failure
and trend information.
Design/Review preventive maintenance incorporated into complaints.