We built our first product quality complaint system in 1991, in partnership with a medical device client that has since grown into one of the largest in the world. That collaboration shaped how we work: listen closely, build around real needs, and keep improving.
In 1998, we brought that experience to large pharmaceutical companies. Today, we support product quality complaint handling across medical device, pharmaceutical, and consumer personal care.
Complaint Management Focused
Specialist in product quality complaints
This is not a side offering. Complaint management is our focus, and we understand the regulatory and operational demands of medical device, pharmaceutical, and consumer personal care environments.
Built for regulated environments
Our system supports 21 CFR Part 11 compliance, giving you the electronic records and electronic signature capabilities FDA expects. You can manage complaints electronically with confidence that your records will stand up to inspection.
Built for volume
Our system handles large daily volumes of complaints without slowing down, so your team can stay on top of intake even when demand spikes.
A solution shaped around you
Every company works differently. We partner with each client to understand their processes and build a solution that fits, rather than asking you to adapt to ours. Each client runs their own version of our base application, configured for their unique needs.
Continuous improvement
Your needs will change, and your system should change with them. We provide ongoing support and enhancements, so the solution keeps pace as your business and requirements evolve.
Proven through partnership
Our longest relationships started in 1991 and continue today. Ready to see how we can support your complaint management process?
