Yes, Castor CDMS is fully compliant with FDA 21 CFR Part 11.
Castor provides the necessary technical controls required for electronic records and electronic signatures in regulated clinical trials:
- Audit Trails: Secure, automated, time-stamped audit trails recording all entries, edits, and deletions, with mandatory GCP reason for change.
- Electronic Signatures (Subpart C): Compliant e-signatures requiring user re-authentication, displaying the signer's name, timestamp, and meaning of the signature.
- Access Control & Security: Unique user accounts, granular role-based permissions, session timeouts, and two-factor authentication (2FA).
- Validation & Data Portability: Validated according to GAMP 5 guidelines under our ISO 9001 / ISO 27001 QMS, with full exportability to human-readable PDF, CSV, and CDISC ODM formats.
Note: Compliance is a shared responsibility—sponsors must establish operational SOPs and validate their specific study build via UAT.
Download our official Annual 21 CFR Part 11 Statements of Compliance or contact Castor Compliance for audit documentation.