Design and build complex integrated software application systems using Agile and Rapid Application Development methods

Client: Food & Drug Administration, Center for Devices and Radiological Health (CDRH)

Issue

FDA performed the premarket approval and postmarket surveillance/recall tracking using a manual paper process that included individual spreadsheets. As a result, the adjudication process was slow, inefficient, and applications fell thru the cracks.

Solution

Created web-based, Java 2 Enterprise Edition (J2EE) case management system to automate many of the Center's premarket and postmarket processes. The system supports over 20,000 workflow operations and 15,000 consultation requests per month while keeping an extensive audit trail of all events for thousands of users throughout FDA.

Results

Dynanet's solution allows CDRH to perform more accurate, efficient, and faster reviews of industry submissions in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA) and other Congressional mandates on turnaround time.