Give us a call: 301.770.9610
Regulatory Business Information Services (RBIS)
The Food and Drug Administration’s (FDA’s) mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws that are designed to protect consumers' health and safety. Several Information Technology (IT) systems have been created to meet mission-critical requirements as well as requirements imposed by executive orders. These systems assist FDA personnel in tracking and managing cases throughout the regulatory workflow and fall within various investments.
Regulatory Business Information Services (RBIS) is considered to be one of these primary investments and contains a set of functionalities that provides data warehouse, reporting, analytics, and firms listings for FDA, in particular for the Office of Regulatory Affairs (ORA).
RBIS provides reporting, firm information, and data storage, thereby supporting the other two ORA investments- Mission Accomplishments and Regulatory Compliance Services (MARCS) and Automated Laboratory Management (ALM). Both of these investments are directly dependent on RBIS to support their workflows. RBIS is the primary source for the historical information that has been collected via MARCS and ALM.
The core component of RBIS includes the Online Reporting Analysis and Decision Support System (ORADSS) data warehouse and reporting system, developed by FDA to provide better support of decision support processes. GNSI is involved in maintaining and providing enhancement to the ORADSS centralized data warehouse and reporting environment. ORADSS provides integrated decision support for regulatory compliance. This involved establishing a central repository of information that supports FDA in achieving its mission of protecting the public from unsafe food, drugs, cosmetics, electronic radiation emitting products, and medical devices, whether of domestic or foreign origin. Specifically, ORADSS has been designed to support the FDA user community in researching, analyzing, and reporting on domestic and foreign operations, product information through its standard and dynamic querying, ad hoc and standard report generation, and trend analysis capabilities. GNSI manages the Help Desk, supporting over 8000 users who run both ad hoc and canned reports against the data warehouse. GNSI provides training, updates, and enhancements in support of the user community.
RBIS also includes support for an integrated, worldwide view of industry information that consists of both foreign and domestic firms and operations data which is critical to providing ORA and the Centers with data for program planning and evaluation, surveillance trending, management information reports, and scientific analysis. FDA receives this information from many sources; therefore, information on firms is often conflicting or duplicative. GNSI is tasked with maintaining the RBIS’s Firm Master Services component, used for nightly domestic firm cleanup. The cleanup process involves a nightly extraction of new and updated domestic firms from the FACTS/OASIS operational database. The extracted firms are cleaned up before being inserted or updated into RBIS Firm Master database. GNSI assures that a uniform and centralized method for accessing and maintaining firm data across the FDA. As the central repository for Firm data, GNSI supports the integration with other systems throughout the FDA provided connectivity to the Firm Master List. As new firms are continually registering with the FDA, GNSI matches and merges redundant registrations. Enhancements are being added to the data, most recently to include latitude and longitude data, and the DUNS number for each firm, allowing more accurate data in support of the FDAs mission.
RBIS tied for the highest overall rating for FDA on the IT dashboard and has been praised by the business sponsor.