Enabling Product, Facilities and Drug Master data

  • Client: 
    Food and Drug Administration (FDA)
  • Industry: 
    Government
  • Services: 
    Requirement Gathering
    Systems Integration

Business Need

Currently, 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  • Out-of-date data (due to the multiple and inconsistent versions of data maintained in many IT systems)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.

Solution Description

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics and products that emit radiation. Currently, 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in exchanging information between IT systems; Inconsistency of data format and content across multiple IT systems; Out-of-date data (due to the multiple and inconsistent versions of data maintained in many IT systems).

Roles, Responsibilities:

NeevSys was engaged by Deloitte/FDA to design, customize and implement multiple Master Data Management efforts using the Informatica Multi-Domain MDM COTS software. We help FDA develop integrated Master Data Repositories on regulated products, and allow the development of an integrated approach to collecting and maintaining firms-data and other business domains, enhance data quality, data profiling, data integration, and enable scalable ETL processes. We support the agency with support for MDM and business informatics, strategic and operational planning, implementation support, user support, and other technical assistance needed to ensure effective, efficient, sustainable, and successful operation for its Master Data Management.

 

In working with the FDA/Deloitte, NeevSys was able to design, develop, customize and implement overlapping software to combine the efforts of disjointed business areas into an effective Master Data Management (MDM) module to receive, store, disseminate, review, and retain regulatory and standard data. We helped on the following Integrity initiatives:

  • Integrity I – As part of this initiative we built the Product Master Data Repository (PMDR) and Solr UI – Built a custom UI for end users to search, review, cleanse and harmonize the data.
  • Integrity II – As part of this initiative we helped the client built the Facilities Master Data Repository (FMDR)
  • Integrity III – As part of this initiative we helped the client built the Drug Product Master (DPR)
  • Integrity IV – As part of this initiative we helped the client built the adverse events integration with the MDM and other FDA CDER systems to report adverse events. This also included the Technology upgrades. This was done as part of the O&M Support.
  • Integrity V - As part of this initiative we helped the client built the Application Master Data Repository (AMDR)
  • Integrity X – O&M support of the Integrity Program which is also entrusted with the overhaul of the FMDR Data model to be a part of the DRUG SUPPLY CHAIN domain of CDER.

We also did requirements gathering, Gap analysis, Cost benefit analysis and project management for the project. We followed the best practice of system development life cycle (SDLC) to develop MDM solution using, but not limited to, Informatica ETL, Informatica MDM, J2EE with various database back-ends (Access, MS SQL or Oracle) meeting the business and investigators requirements. We also used web-based tools such as Adobe Flash, scripting and formatting languages such as XHTML, CSS, XML and JavaScript, utilizing established Best Practices for usability and Section 508 compliance to support FDA.

Benefits Delivered

An integrated MDM platform would allow the Agency to deliver the following operational outcomes:

  • 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.

About Company

NeevSys, Minority Women Owned Small business based in Chantilly, VA; provides a full suite of system design, development, and integration services aimed at reducing the cost of operations, increasing customer satisfaction and increasing workforce productivity.

To see a detailed list of our works, please see our case studies.

Our Office

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Chantiily, VA 20152
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