QCA Application Assures Accountability for FDA Submissions

ZAI developed the Quality Control Agent (QCA) for the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) to provide 100% accountability of incoming submissions received via the Electronic Gateway.

CDER receives the largest volume of regulatory submissions within the FDA, and QCA ensures quick and accurate delivery of the necessary documentation to the ~3,500 FDA reviewers. It performs pre-market review on new and investigational prescription drugs, biological therapeutics drugs, over-the-counter drugs, and generic drugs. It also reviews promotional material and performs post market evaluation of drugs.

QCA is an automated workflow, workload, productivity, and quality tracking IT system that has enabled ZAI to increase production capacity 600% and saved the FDA more than $1.2 million over the past eight years. In addition, ZAI implemented improvements to QCA that allow multi-user support for a growing number of ZAI and FDA users. ZAI introduced new features and functionality, improved system performance, and introduced improved security.

ZAI also integrated QCA into another ZAI developed system – P3 (Planning, Performance, and Productivity). P3 is ZAI’s modular management tool that facilitates managing workloads, workflow, productivity, and quality performance at the individual, team, task, and contract level. The new web-based P3 system provides real-time status to managers, processing staff, and FDA users.

In addition to the advantage of moving to a more stable and robust infrastructure, ZAI was able to support new FDA business requirements, including automated Gateway submission rejection and support for a new version of Gateway submissions (version 4 of the Electronic Common Technical Document).