Certivo – FDA 21 CFR Part 11 compliant electronic signatures

Summary: Certivo is an electronic signature platform designed specifically for regulated industries, ensuring FDA 21 CFR Part 11 compliance. It offers ALCOA+ audit trails with hash-chain verification, 25-year document retention, workflow automation, role-based access control, and built-in multi-factor authentication.

What it does

Certivo provides secure electronic signatures with TOTP two-factor authentication and cryptographic hash chains for tamper-evident audit trails. It supports workflows for clinical trials, digital lab notebooks, SOPs, and other regulated documents.

Who it's for

It is intended for life sciences, pharma, medical device, and clinical trial teams requiring compliant, legally binding electronic signatures.

Why it matters

Certivo addresses the complexity of regulatory compliance by delivering a purpose-built, cost-effective e-signature solution tailored to strict industry standards.