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.
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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
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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
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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.