Leading Glucose Monitoring Manufacturer
Smarteeva Solves High-Volume Complaint Handling for a Leading Glucose Monitoring Company
Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries.
One of the largest manufacturers and producers of glucose monitoring systems required an overarching system for Post-Market surveillance and effective complaint management. Despite having a quality system, the ever-changing business landscape and growing volumes made scalability impossible without a new approach.
Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries.
The Challenge
5M annual complaints overwhelming existing QMS, 25-step complaint lifecycle, untouchable customizations
- Previous QMS not scalable: 5M+ annual complaints and 300K+ MDRs needed speed and responsiveness
- Extensive customizations made the previous system untouchable; any update caused outages
- 25 process steps required to go through the complaint lifecycle
- User community could not track information changes or make informed regulatory decisions
How Smarteeva Solved It
Smarteeva partnered with the customer to design and deploy a purpose-built solution:
- Scalable platform with no performance loss at 5M complaints and 165M+ Audit Trail entries
- User-friendly Audit Trail UI to help users quickly identify critical information
- Fully automated MDR reporting: creation, completion, and FDA submission in minutes
- Automated decision trees and regulatory reports for EU and multiple countries
- Scalable integration with customer service applications exchanging 250K+ daily messages
Results
5M+
Annual complaints processed without performance loss
300K+
MDRs handled annually on the platform
Minutes
MDR creation to FDA submission time
250K+
Daily messages exchanged via service integration
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