Case Study: FDA improves inspection operations with REI Systems' end-to-end digital modernization

FDA manages 78,000+ operations with REI Systems

The U.S. Food and Drug Administration (FDA) faced challenges with its legacy inspection processes as operational volume and data complexity grew. Its tools were managed across multiple systems, creating inefficiencies, performance issues, and an increased administrative burden for staff. To address this, the FDA partnered with vendor REI Systems on an end-to-end digital modernization initiative.

REI Systems modernized the ecosystem by implementing the Assignment Management System (AMS) to centralize planning and by enhancing the eNSpect application for field inspection execution. This integrated platform streamlined workflows, improved data quality, and significantly increased operational capacity. The results were substantial, with AMS managing over 78,000 operations and eNSpect processing more than 453,000 documents in a two-year period, all without a corresponding increase in administrative burden.

U.S. Food and Drug Administration (FDA)