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 CFR 21 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 CFR 21 Part 11 system used by the FDA.
FDA uses ORA U 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 2019 and expanded to include new technologies.
UL EduNeering strives to improve the software security, reliability and quality of ComplianceWire through the effective application of world-class systems and software development methods, practices and techniques. UL EduNeering provides tailored technical program management by applying software engineering and quality assurance best practices to evaluate the correctness and quality of critical and complex software systems throughout the system development life cycle.