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:

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

ICH Compliant GCP E6
ICH GCP E6

International clinical trial standard focusing on ethical conduct, data quality, and patient protection.

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
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
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.