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:
No single source of truth for corresponding business-related data, from investigational to post-market and safety surveillance phases
Difficulty in exchanging information between IT systems
Inconsistency of data format and content across multiple IT systems
Out-of-date data (due to the multiple and inconsistent versions of data maintained in many IT systems)
Insufficient management of multiple data identifiers
Inability to track data changes and their provenance over time.
How Neevsys Helped
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.
Results Delivered
An integrated MDM platform would allow the agency to deliver the following operational outcomes:
Provide a single integration infrastructure to manage master-data business transactions (i.e. single source of truth)
Ensure the synchronization of data to assure high data quality
Improve the data governance process
Reduce data management costs
Centralize data sources for reporting and analysis needs
Share data with all business processes and IT systems in a distributed manner
Accommodate regulatory changes in a scalable and flexible manner.