Navigating 21 CFR Part 11
A practical guide for data science and IT leaders
Download the white paper
AI developers working in life sciences are under constant pressure to innovate faster. Yet regulatory demands like FDA 21 CFR Part 11 require careful adherence — missteps can be costly and risk hefty fines, product recalls, and lasting reputational harm. One industry study estimates that life-science companies spend $7.5 to $9 billion annually just to address the aftermath of FDA warning letters.*
Complying with 21 CFR Part 11 and GxP requires both well-defined processes and a strong technology foundation. Domino Data Lab provides the technical capabilities that help data science and IT teams meet these demands, making it easier to stay compliant while speeding the delivery of safe, effective therapies.
Read this informative white paper to learn:
- FDA 21 CFR Part 11 core technical and procedural requirements
- Broader GxP compliance considerations
- How Domino addresses FDA 21 CFR Part 11
*Source: Anderson, Randy, and Christabel Tan. 2023. “FDA Warning Letters, Consequences and Costs to the US Medical Device Industry.” Journal of Industrial Engineering and Management Volume 12:05, 2023.
