Document CAPA execution and effectiveness verification proving successful problem resolution.
Criteria | Information |
---|---|
CAPA Title | Software Compatibility Issue - Inconsistent Glucose Readings on Specific Smartphone Models |
CAPA Number | CAPA-2024-002 |
CAPA Information | Description |
---|---|
Source of CAPA | Post-market surveillance analysis of customer complaints received through support system over 3-month period |
Product and Version Affected | GlucoTrack Mobile App versions 2.1.0-2.1.3, affecting Samsung Galaxy S22 and Google Pixel 6 devices |
Description of Problem | Users report glucose readings varying by ±15% compared to reference meter, occurring intermittently during peak usage hours |
Description of Investigation | Analysis of 47 complaints, device logs, and compatibility testing revealed memory management issues during high CPU load conditions on affected smartphone models |
Root Cause | Inadequate memory allocation handling in glucose calculation algorithm when running on devices with specific Android memory management configurations |
What should be done if planned CAPA actions prove ineffective?
How long should you monitor CAPA effectiveness before closure?
What evidence is required to verify CAPA effectiveness?
Can CAPAs be closed if not all planned actions were completed?
How should CAPA reports be integrated with management review?