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Separate systems and disjoint business processes provide FDA with information from various sources for their respective business areas. The Agency is struggling to harmonize the tracking of regulated establishments, products, associated application data, regulatory activities, and adverse events. This situation was resulting in:
NeevSys supports FDA to design, customize and implement multiple Master Data Management efforts using the Informatica Multi-Domain MDM COTS software. NeevSys worked with FDA to do the required systems analysis, design, development, test, implementation, training, and maintenance to cover all aspects of life-cycle software database development as well as designing and maintaining the MDM solution. The technology used— Java, Informatica PowerCenter, Informatica MDM, Business Objects, Tableau, and QTP.
An integrated MDM platform would allow the agency to deliver the following operational outcomes: