Yes, Castor is officially certified for ISO 27001:2022 (Information Security Management).
In addition to ISO 27001, Castor holds key international certifications and adheres to global regulatory frameworks governing clinical research data:
Key Certifications
- ISO/IEC 27001: Information Security Management System (ISMS), safeguarding data availability, integrity, and confidentiality (certified since 2017).
- NEN 7510: Information Security in Healthcare (the recognized healthcare standard covering health data and patient privacy).
- ISO 9001: Quality Management System (QMS), demonstrating structured quality assurance across our software development and operational lifecycle.
Regulatory Compliance
Castor CDMS is built to support full compliance with global regulatory standards for clinical trials and health data protection:
- ICH-GCP (E6 R2): Good Clinical Practice guidelines.
- FDA 21 CFR Part 11: Electronic records, electronic signatures, and audit trails.
- EU Annex 11 (EudraLex Vol 4): Computerised Systems in clinical research.
- Privacy Legislation: Full compliance with the EU General Data Protection Regulation (GDPR), HIPAA, and applicable local data privacy laws.
- GAMP 5: Computerized system validation principles (Category 4 software).
Need to View Certificates or Security Documentation?
- Review our full overview and download certificates on our ISO Standards Documentation page.
- For vendor questionnaires, SOC reports, or formal compliance requests, please review our Security Statement or contact Castor Support.