Build, validate, & share AI workflows for clinical operations

This 2024 guidance serves as a global framework to strengthen clinical trial ecosystems by establishing universal standards for efficiency, scientific quality, and ethical conduct. Use this framework to minimize research waste and foster patient-centered, inclusive research that is integrated into health systems to generate reliable evidence for both routine and emergency health needs.

21 CFR Part 11 establishes the United States Food and Drug Administration's (FDA) criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and legally equivalent to paper records and handwritten signatures. Use this framework to verify your processes ensure the authenticity, integrity, and confidentiality of electronic data while maintaining strict compliance and data security.

These guidance documents establish a risk-based framework to ensure that AI models used in drug development and medical devices are reliable, transparent, and free from bias, setting clear standards for their credibility and safety. Use this framework to design validation studies and documentation strategies (such as defining a "Context of Use" and monitoring data drift) to prove to the FDA that their AI tool performs accurately and ethically throughout its entire lifecycle.