Addressing Consent Decrees
Learn how USDM enabled a global medical device company to address a 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 Situation
- Global medical device company
- Customer struggled to keep up with service orders and complaints
- Customer needed help to close out complaints faster
- Internal staff could not support Consent Decree timeline
- Scope of project included processing more than 600,000 service orders
The Solution
- USDM provided a team of 36 consultants with USDM leadership to develop a sustainable process for handling service orders and complaints
- USDM applied its domain expertise to quickly address the customer’s backlog of 600,000 service orders
- USDM helped customer reduce its time to process and close out complaints
The Results
- Customer achieved FDA Consent Decree deadlines and remediation
- Customer uses GxP best practices to manage complaints
- Customer now has a more efficient complaint handling process
Download the Complaint and CAPA Management solution overview to learn more.