Maintain centralized register enabling CAPA trend analysis and management oversight activities.
CAPA ID | Source of CAPA | Problem | Actions | Initiation Date | Verification Date | Close Date |
---|---|---|---|---|---|---|
CAPA-2024-001 | Internal Audit | Incomplete design review documentation for software module updates | Updated design review procedures, retrained development team, implemented automated documentation checks | 2024-01-15 | 2024-02-28 | 2024-03-15 |
CAPA-2024-002 | Customer Complaints | Software compatibility issues causing inconsistent glucose readings on specific smartphone models | Released software hotfix, expanded compatibility testing, enhanced post-market surveillance monitoring | 2024-03-10 | 2024-06-15 | 2024-06-30 |
CAPA-2024-003 | Post-Market Surveillance | Increased user reports of app crashes during peak usage hours | Optimized memory management, implemented load balancing, added performance monitoring | 2024-04-20 | 2024-07-10 | 2024-07-25 |
CAPA-2024-004 | Management Review | Supplier quality issues affecting component delivery schedules | Updated supplier qualification criteria, implemented backup supplier program, enhanced supplier monitoring | 2024-05-05 | 2024-08-20 | 2024-09-10 |
CAPA-2024-005 | Customer Complaints | User interface confusion leading to incorrect device setup | Redesigned setup wizard, updated user manual, conducted usability testing with target users | 2024-06-12 | 2024-09-30 | 2024-10-15 |
CAPA-2024-006 | External Audit | Inadequate training records for quality management system procedures | Implemented digital training tracking system, updated training procedures, conducted refresher training | 2024-07-08 | 2024-10-25 | 2024-11-10 |
CAPA-2024-007 | Risk Assessment | Potential cybersecurity vulnerability in data transmission protocols | Upgraded encryption protocols, implemented additional security testing, updated cybersecurity procedures | 2024-08-15 | 2024-11-30 | 2024-12-15 |
How often should the List of CAPAs be updated and reviewed?
What information should be included in the List of CAPAs versus detailed CAPA documents?
How should recurring problems be handled in the List of CAPAs?
What trends should be monitored in CAPA data?
How should the List of CAPAs support management review activities?