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EduNeering and FDA Extend Collaborative Agreement

A five-year extension of FDA's first learning technology Cooperative Research and Development Agreement (CRADA) provides FDA with new technologies

July 5, 2006 - Princeton, New Jersey - EduNeering, a leading provider of knowledge management solutions to improve regulatory compliance and business performance, and the U.S. Food and Drug Administration (FDA) have extended their Cooperative Research and Development Agreement (CRADA) for five years. This CRADA represents the first technology agreement of this kind between the FDA and a private-sector company.

"FDA selected EduNeering in 1999 as a strategic partner in the mission to ensure the safety of our nation's food and drug supply, said Donald A. Deieso, President and CEO of EduNeering. "The cornerstone of our agreement was EduNeering's development of the Office of Regulatory Affairs' virtual university, ORA U, accessible to more than 30,000 federal, state, local and tribal regulators. This most recent extension both expands and extends our learning solution for FDA by including many of the new technologies we have developed. We're gratified by the confidence FDA has shown in our technologies and our partnership, which supports the life science industry's commitment to compliance."

ORA U is currently based on EduNeering's web-based ComplianceWire^® technology platform, a fully validated knowledge management system designed to meet the high-security needs of FDA-regulated organizations, including 21 CFR Part 11 requirements. ComplianceWire enables the function-specific distribution of designated coursework, validates and documents receipt and understanding of the subject matter, and supports centralized storage and reporting to promote management control over all learning activities.

Since signing the original CRADA, EduNeering and FDA have co-developed more than 100 web-based learning activities and courses for ORA U. To date, more than 100,000 learning activities have been completed through the program. The same solution developed under the CRADA is available exclusively to EduNeering's life sciences clients, both regulated industry and governmental agencies, including the US Air Force and US Army. This solution provides the same level of preparedness and learning accessible to the FDA, and is used for certification of its inspectors.

Among the new technologies included under the CRADA renewal are:

• Virtual Audit, creates an online simulation of an audit from the perspective of either the regulator or regulated. This immersive and instructive technology creates a virtual work environment for evaluating a site. The virtual audit is designed to be used by FDA as a culmination of an FDA inspector's certification program.
• Visual Job Aids^SM (VJAs), an interactive learning and reference aid that uses text, sound, video clips, graphics and animation to provide consistent, accurate guidance for job-specific processes or procedures. VJAs are especially effective for capturing know how of experienced workers.
• QuizCreator^SM and ExamCreator^SM, enabling managers to quickly generate and distribute course-specific quizzes and tests to confirm and document learner comprehension of subject matter;
• Forms^SM, which allows the on-demand creation and distribution of function-specific forms required by the managing organization;
• Critical Information Control System^® (CICS), within the ComplianceWire platform, enabling the distribution, documentation and control of all critical information including Standard Operating Procedures (SOPs), Codes of Conduct, organizational policies and regulatory updates. CICS is being used to document on-the-job-training of FDA personnel.

All of EduNeering's technology solutions are being made available via advanced delivery methods, including PDAs, portable players, and Video iPods^®.