IQ/OQ/PQ Validation Results
Validation Summary
60
Total Test Cases
60
Passed
0
Failed
100%
Pass Rate
Installation Qualification (IQ)
11 tests
✅ All Passed
Operational Qualification (OQ)
20 tests
✅ All Passed
Performance Qualification (PQ)
29 tests
✅ All Passed
Test Execution Details
Validation Approach
The VDC system validation followed a risk-based approach aligned to GAMP 5 Category 4 (configured product):
- Installation Qualification (IQ): Verified AWS infrastructure deployed correctly via CloudFormation with proper security configurations
- Operational Qualification (OQ): Tested individual Lambda functions, API endpoints, and system components in isolation
- Performance Qualification (PQ): Validated complete end-to-end workflows with role-based scenarios (Submitter → Approver)
Test Environment
- Environment: vdc-dev (DEV environment, dedicated AWS resources)
- Test Period: January 5-8, 2025
- Test Users: williamoconnellpmp+submitter1@gmail.com, williamoconnellpmp+approver1@gmail.com
- Test Data: Sample PDF documents (protocols, SOPs)
Acceptance Criteria
System considered validated if:
- ✅ 100% of critical requirements tested and passed
- ✅ No high-severity defects open
- ✅ All ALCOA+ principles demonstrated
- ✅ Complete audit trail for all actions
- ✅ Role-based access controls enforced
Result: All acceptance criteria met. System approved for production use.
Traceability
All test cases trace back to specific URS requirements. See Requirements Traceability Matrix for complete mapping.
Conclusion
The VDC system has successfully completed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. All 60 test cases passed, demonstrating 100% compliance with user requirements and regulatory expectations (GxP, CSV, 21 CFR Part 11).
The system is validated and approved for production use in regulated Life Sciences environments.
Approval
Test Lead
William O''Connell
January 8, 2025
Electronically Signed
Quality Assurance
William O''Connell
January 8, 2025
Electronically Signed
System Owner
William O''Connell
January 8, 2025
Electronically Signed