Complaint Management

Manufacturers often view product complaint management in a negative light. However, effective complaint management can provide tremendous value for manufacturers and patients. Superior complaint management gives manufacturers an advantage over their competition. It helps them manage product-related risks, optimize manufacturing processes, strengthen customer relationships, and meet regulatory requirements.

Kymanox has implemented and supported effective complaint management systems for clients ranging from large pharmaceutical and medical device manufacturers to small compounding pharmacies. We can help you improve all aspects of complaint management, including:

  1. Establishing policies and procedures to ensure that complaints are handled and triaged appropriately and efficiently.
  2. Receiving, evaluating, and tracking complaints to ensure that timely, efficient actions are taken to prevent breaches in compliance or return to a state of compliance.
  3. Investigating complaints to ensure that root cause determinations are technically accurate, documented, and justified. This may include reviewing related complaint files, manufacturing records, and testing results.
  4. Trending and analyzing complaint data to support periodic product reviews, identification of preventive actions, and FDA reporting.
  5. Managing execution of Corrective Actions and Preventive Actions (CAPAs) to improve patient experience and reduce the frequency of future complaints.