Overview
Learn how USDM enabled a global medical device company to address an FDA Consent Decree and close out a complaints backlog of over 600,000 service orders. A sustainable process was developed to help the customer reduce the time it takes to process, code, and close out complaints.
The Challenge
A global medical device company was operating under an FDA Consent Decree and struggling to keep up with the volume of service orders and complaints flowing into its quality system. The scope of the problem was significant: more than 600,000 service orders needed to be processed, coded, and closed out.
- The customer struggled to keep up with incoming service orders and complaints.
- The customer needed to close out complaints faster to satisfy regulators.
- Internal staff could not support the Consent Decree timeline.
- The backlog included more than 600,000 service orders awaiting remediation.
Missing a Consent Decree deadline carries real consequences, and complaint records are a core data integrity obligation. The customer needed both speed and a process that would hold up to regulatory scrutiny.
The Approach
USDM provided a team of 36 consultants, backed by USDM leadership, to develop and run a sustainable process for handling service orders and complaints. Rather than simply adding hands, the team built a repeatable workflow the customer could continue to operate after remediation.
- Stood up a 36-person team with USDM leadership to design a sustainable, repeatable complaint handling process.
- Applied USDM domain expertise to quickly address the backlog of 600,000 service orders.
- Reduced the time required to process, code, and close out complaints.
The work was grounded in GxP best practices and the kind of 21 CFR Part 11 record discipline FDA expects from a complaint handling system, so every closure stood up to audit. Embedding the process within a continuous compliance approach meant the customer would stay in control long after the deadline passed.
The Results
The remediation effort delivered on the regulatory deadline and left the customer better positioned for the future.
- Customer achieved FDA Consent Decree deadlines and remediation.
- Backlog of 600,000+ service orders processed and closed out.
- Customer now uses GxP best practices to manage complaints.
- Customer now has a more efficient complaint handling process.
By pairing experienced people with a sustainable, GxP-aligned process, the customer cleared its backlog, met its Consent Decree obligations, and walked away with a complaint handling capability it can run on its own. To learn more, download the Complaint and CAPA Management solution overview, or contact USDM to discuss your own remediation timeline.