May 14, 2025 — Today we announced the launch of support for FDA 21 CFR Part 11 within our 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 this 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 our intuitive compliance automation platform.
With this release, we are further strengthening our 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.