- Services:Requirement Gathering
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 results 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- Out-of-date data (due to the multiple and inconsistent versions of data maintained in many IT systems)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.
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. 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:
- 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 source 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.