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PROFESSIONAL SERVICES

Part 11 Validation Packets

Key Resources

  • Installation qualification report
  • Executed test suites
  • Validation compliance statement
  • Standard operating procedures

Simplified Path to eSource + EDC Validation

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 Compliance Statement

Summarizes intended use of the system and validation activities, including test results

Standard Operation Procedures

Documents standard processes for key Part 11 requirements, including training, testing, administration, risk assessment and change management

Ready to simplify your system validation process?

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