Computer System Validation, Part 11 Still Resonate in Industry

The vast majority of FDA-regulated life sciences companies still believe computer system validation and 21 CFR Part 11 compliance are important even as agency enforcement lags, according to EduNeering CEO Donald Deieso.

"Most clients I meet with still say Part 11 is important," he told PIR. "It is exceptional to find a potential client of any size that doesn't think about Part 11 and [related] validation issues," he said. That includes companies of all stripes, he said, including drug, device and biologics shops.

Most clients view Part 11 and validation compliance as costing roughly the same as going without, he noted.

Deieso spoke shortly after agreeing to extend EduNeering's Cooperative Research and Development Agreement (CRADA) with the FDA for five years. Selected by the agency in 1999, the CRADA with EduNeering was the first technology agreement of this kind between the FDA and a private-sector company.

The cornerstone of the agreement was EduNeering's development of the FDA's 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," Deieso said.

FDA Agreement Renewed

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 Part 11 compliance. 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 the 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, EduNeering said.

The same solution developed under the CRADA to certify FDA inspectors is available exclusively to EduNeering's life sciences clients, both regulated industry and governmental agencies, including the U.S. Air Force and U.S. Army.

"What's made this work is the notion that the regulated community can receive exactly the same training as FDA inspectors," Deieso said.

Among the new technologies included under the CRADA renewal are:

Virtual Audit, which 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 the FDA to evaluate the culmination of an FDA inspector's learning in the program. Visual Job Aids (VJAs), which are interactive learning and reference aids that use 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 and ExamCreator enable managers to quickly generate and distribute course-specific quizzes and tests to confirm and document learner comprehension of subject matter. Forms, which allow the on-demand creation and distribution of function-specific forms required by the managing organization. Critical Information Control System (CICS), within the ComplianceWire platform, enables the distribution, documentation and control of all critical information, including standard operating procedures, codes of conduct, organizational policies and regulatory updates. CICS is being used to document on-the-job training of FDA personnel.

In addition, all of EduNeering's technology solutions are being made available via advanced delivery methods, including personal digital assistants, portable players and Video iPods.

For more information, go to www.eduneering.com (http://www.eduneering.com). -- Michael Causey