Quality standards

Compliant with laws and regulations

We are developing a fully regulatory-compliant and quality-assured Electronic Data Capture (EDC) system for use in regulated clinical trials.

OpenEDC is compliant with these regulations:

  • FDA Compliant 21 CFR Part 11

    FDA 21 CFR Part 11

    Regulates electronic records and signatures in clinical trials to ensure data integrity and traceability.

    Among others, ensured by:

    • Automatic and audit-proof audit trail with timestamp
    • Cryptographic electronic signatures after re-login
    • Password policies and automatic logout during inactivity
  • ICH Compliant GCP E6(R3)

    ICH GCP E6(R3)

    Defines international ethical and scientific quality standards for conducting clinical trials.

    Among others, ensured by:

    • Logged role and rights system for write and read permissions
    • Two-factor authentication (mandatory per study if desired)
    • Source Data Verification (SDV) and Query Management
  • EU Compliant Annex 11

    EU Annex 11

    Supplements the EU-GMP guidelines and describes requirements for computerized systems in pharmaceutical manufacturing.

    Among others, ensured by:

    • Risk-based system validation according to GAMP 5
    • Documented and versioned system changes
    • Regular data backup and recovery testing

Unless otherwise agreed, all data is processed and stored exclusively in the ISO 27001-certified Telekom Cloud in Germany.