May 14, 2025 — Chicago, IL — Ryden, a leading provider of AI compliance technology, today announced the launch of support for FDA 21 CFR Part 11 within the Ryden application. This new capability allows life sciences organizations to seamlessly meet the stringent electronic records and electronic signatures requirements set forth by the U.S. Food and Drug Administration.
FDA 21 CFR Part 11 is a critical regulation for pharmaceutical, biotech, and medical device companies that manage data electronically. With Ryden’s new module, teams can now ensure that AI models, data pipelines, and associated documentation align with the FDA’s criteria for security, audit trails, user access, and data integrity — all within Ryden’s intuitive compliance automation platform.
“As AI becomes increasingly embedded in life sciences; compliance with FDA regulations is more essential than ever,” said Adam Foresman, CEO of Ryden. “Our goal is to eliminate the burden of manual audits while giving organizations full confidence that their AI systems are compliant, traceable, and ready for regulatory scrutiny. FDA Part 11 support brings us one step closer to that vision.”
With this release, Ryden further strengthens its position as the go-to platform for organizations seeking proactive, continuous AI compliance — reducing the need for periodic third-party audits and enabling real-time compliance.
This feature is now available to all enterprise customers.
About Ryden
Ryden is the AI compliance platform that reduces the need for audits. Built for regulated industries, Ryden continuously monitors, and identifies compliance issues — enabling enterprises and consulting partners to stay ahead of emerging regulations with ease. Learn more at ryden.ai.