FDA CRADA

The US Food and Drug Administration (FDA) has a unique partnership with UL: a technology Cooperative Research and Development Agreement (CRADA), in which UL provides the online training, documentation, and 21 CFR Part 11 validated technology system for "ORA U," the virtual university for the agency's Office of Regulatory Affairs (ORA). Our clients rely on the same 21 CFR Part 11 system used by the FDA. 

FDA relies on UL's ComplianceWire as the technology behind ORA U, which is used to train and certify more than 35,000+ federal, state, local and now global investigators in the areas of quality and compliance. To date, more than 100,000 learning activities in areas such as GMP, GCP, and GLP have been created.

The CRADA solution, available exclusively to UL's pharmaceutical, biologics, and medical device clients, provides industries with the same level of preparedness and learning on which FDA relies. The CRADA was recently renewed through 2024 and expanded to include new technologies. 

 

Visit the US FDA site to learn more.