Certivo

FDA 21 CFR Part 11 compliant electronic signatures

Certivo とは？

Certivo is an electronic signature platform purpose-built for regulated industries — clinical trials, pharma, medical devices, and life sciences. Unlike general-purpose e-signature tools, every feature is designed around FDA 21 CFR Part 11 compliance from the ground up. Features include ALCOA+ compliant audit trails with hash-chain verification, 25-year document retention, workflow automation, role-based access control, and built-in MFA. Compliant with FDA, EU CTR 536/2014, MHRA 2026, and GDPR.

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