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Part 11 Validation Packets

Resources to streamline your Advarra eSource + 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

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

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