FDA - EDR

ZAI assisted the Food and Drug Administration (FDA) in conceptualizing, implementing, and now operating and maintaining the Electronic Document Room (EDR) that handles all electronic submissions. We developed and operate IT tools that not only facilitate efficient processing, but perform automated quality checks on electronic submissions to ensure completeness. To manage and track performance on the extreme workloads, we developed our P3 (Planning, Performance, and Productivity) aplication to monitor/manage workflow, productivity, and quality statistics. We also digitize and convert documents and photographs into PDF files with Optical Character Recognition (OCR) and in compliance with Section 508 requirements.