PROFESSIONAL SERVICES
Part 11 Validation Packets
Resources to streamline your Advarra EDC system validation process, ensuring compliance with 21 CFR Part 11. Reduce the burden of testing and documentation with precompiled validation materials, available through an annual subscription.
Key Resources
- Validation plan
- Traceability matrix
- Installation qualification report
- Executed test suites
- Validation summary report
Simplified Path to EDC Validation
Validation Plan
Describes activities, deliverables, and resources necessary for testing the Advarra EDC system, including installation and operational qualification within a customer-simulated environment.
Traceability Matrix
Links each test suite to user requirements, ensuring comprehensive testing and full coverage.
Installation Qualification Report
Documents the successful installation and configuration of the Advarra eReg, eConsent, or eSource + EDC instance, providing objective evidence.
Executed Test Suites
Complete test suites with objective evidence and screenshots to verify functionality.
Validation Summary Report
Summarizes validation activities, acceptance criteria, and results to ensure the system meets required standards.
