Data analytics empowers stakeholders to use organizational data to improve decision making, increase productivity, and realize significant cost savings.
Case Study: Master Data Management and Data Quality Services
The Food and Drug Administration (FDA)’s mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws designed to protect consumers’ health and safety. Several IT systems assist FDA personnel in tracking and managing cases throughout the regulatory workflow. Regulatory Business Information Services (RBIS) is one of the primary investments and contains a set of functionalities that provide data warehouse, reporting, analytics, search, and data quality services for FDA.
The core component of RBIS includes the Online Reporting Analysis and Decision Support System (ORADSS) data warehouse and reporting system. ORADSS provides integrated decision support for regulatory compliance. This includes 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. ORADSS supports FDA user community in researching, analyzing, and reporting on domestic and foreign operations, as well as providing product information through its standard and dynamic querying, report generation, and trend analysis capabilities.
RBIS also includes support for an integrated, world-wide view of industry information that consists of both foreign and domestic firms and operations data, which is critical to providing FDA with data for program planning and evaluation, surveillance trending, management information reports, and scientific analysis.
Salient CRGT was tasked with modernizing the RBIS application portfolio while maintaining legacy applications. The RBIS application portfolio includes the Firm Master List Services (FMLS) component, used to standardize, validate, and de-duplicate firms generated by multiple systems throughout FDA.
Salient CRGT is modernizing FMLS into a Master Data Management (MDM) System. This effort includes adopting MDM best practices, implementing cutting-edge MDM technology, and adding a robust data governance process to sustain data quality. Furthermore, Salient CRGT maintains and provides enhancements to the ORADSS centralized data warehouse and reporting environment. Our team manages the Help Desk that supports over 8,000 users and provides training, updates, and enhancements to the user community. Additionally, Salient CRGT is adding a powerful search capability that enables a fast retrieval of both structured and unstructured data.
The recent inclusion of dashboards and other data visualization tools help identify trends and patterns of interest for ORA decision makers. The addition of a Geographic Business Intelligence search capability displays firm information on dynamic geographic maps. RBIS offers multiple web services used by external applications to standardize and validate addresses, match incoming names and addresses, and return DUNS information to improve matching. These services help to generate clean data at the source. Through these innovative projects, Salient CRGT assures a uniform and centralized method for accessing and maintaining “golden copy” firm data across FDA.
RBIS incorporates both Operations & Maintenance (O&M) and Development, Modernization, and Enhancement (DME) tasks. Salient CRGT uses a core team of fixed staff on the O&M tasks and matrixed staff to cover both O&M and DME tasks. This blended approach enables us to respond to changing priorities, while maximizing team member productivity by cross-training on multiple systems in order to reduce overall staffing levels.