FDA Unified Registration and Listing System (FURLS)

The Bioterrorism Act of 2002 mandated the FDA to establish an online Food Facility Registration system by October 12, 2003. The FDA Unified Registration and Listing System (FURLS) was built to register all domestic and foreign facilities that export food to the U.S. electronically. It is a web-based system developed in Java that supports multiple web browsers and computer platforms. FURLS was architected to be a scalable, flexible, and interoperable system with a documented capability for handling a substantial amount of traffic simultaneously. With less than a year to develop this system, GNSI and the FDA were forced to set a very aggressive schedule with many interrelated activities occurring in parallel. GNSI worked closely with the project officer and FDA regulatory staff to quickly analyze the impact of new requirements, to prioritize the new requirements, and to integrate the changes into the existing development schedule.

GNSI was deeply involved with the full system life cycle development and implementation in the FURLS project including software, hardware, and network components. FURLS is a mission-critical system that requires close coordination among multiple FDA Centers. The FURLS implementation was the first web-based system to deploy on the FDA extranet. In addition to developing the FURLS application, GNSI has provided system and database administration support and level 2 and 3 help desk support. Despite changing requirements, GNSI was able to design, develop, and implement FURLS in eight months. GNSI was given high marks for its work on FURLS. In May 2004, GNSI was awarded an FDA Commissioner’s Special Award for its work on FURLS. GNSI was able to meet the congressionally-mandated deadline for FURLS within the allocated budget, despite a very aggressive timeframe and constantly-changing requirements.

Since the initial implementation of FURLS, GNSI has helped the FDA realize the vision of a unified registration and listing system. New modules have been added to FURLS for drug facility registration and for medical devices registration and listing. GNSI is currently working on adding a new function for Shell Egg Producer registration and to support Tobacco registration and listing.

FURLS is developed using Java 2 Enterprise Edition (J2EE), Oracle 10G RAC, and runs on a Sun Solaris platform.