Electronic Signatures for Clinical Trials

FDA 21 CFR Part 11 establishes the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records. Klyverity supports Part 11 compliance programs through validation documentation, ALCOA+ audit trails, system access controls, unique user identification, and configurable record retention up to 25 years.

EU Clinical Trial Regulation 536/2014 is the European regulatory framework for clinical trials. Article 58 requires sponsors to retain the clinical trial master file for at least 25 years after the trial ends. This ensures long-term safety monitoring and allows regulatory authorities to access complete trial documentation.

ALCOA+ is the data integrity framework required by FDA and EU GMP Annex 11. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. Klyverity audit trails are designed around ALCOA+ principles.

Klyverity one-click regulatory export generates a complete compliance package including full audit trail with hash-chain verification, document access logs, GDPR Article 30 processing records, and retention settings. Exports are available filtered by date range, workflows, or requesting authority (FDA, MHRA, EMA).

No. Recipients receive a secure signing link by email, but FDA 21 CFR Part 11 requires every signature to be attributable to a verified individual, so a first-time recipient creates a signer account with a password and sets up an authenticator app (TOTP) before signing. An emailed one-time code does not satisfy this check, and there is no anonymous signing path. Every signature event is then audited with IP address, timestamp, and device information.

Absolutely. Klyverity uses bank-level encryption (TLS 1.3 in transit, AES-256 at rest) with multi-tenant data isolation. All passwords are hashed with bcrypt, and we support two-factor authentication. Documents are verified with SHA-256 hash integrity checks.