Use HP Quality Center in Validated Environments
QC eApprove provides controlled workflow and electronic signatures required to enable use of HP Quality Center in
regulated environments and allow compliance with 21 CFR Part 11. Genilogix developed eApprove through core functionality
found in HP Quality Center to assure that your eApprove implementation will survive as HP Quality Center evolves.
With eApprove, companies can provide electronic signatures to approve requirements, tests, test sets, runs, and defects.
The related workflow can be configured to match your process.
To reduce costs and shorten validation of QC eApprove and HP Quality Center, Genilogix offers a customizable validation documentation suite that includes:
- Validation Plan
- Functional Requirements Specification (FRS)
- Design and Configuration Specification (DCS)
- Installation Qualification (IQ) / Configuration Verification
- Operational Qualification (OQ) / Functional Verification
- Performance Qualification (PQ) / Requirements Verification
- Risk Assessment
- Traceability Matrix
- Validation Summary Report
For more information, please contact us >