Registrar Corp’s FDA Compliance Monitor now includes RegiScore, a patent-pending risk evaluation tool that calculates compliance scores for non-U.S. suppliers of FDA-regulated products. This software is the first to enable importers to easily calculate the risk a supplier may present based on their FDA compliance and shipment history.
RegiScore is a proprietary product that evaluates data from over 200 million shipments of FDA-regulated goods as well as FDA inspections, warning letters, import alerts and recalls related to suppliers and their products within the past five years. The impact of a compliance event on a supplier’s score depends on its recency and severity.
Users can view a supplier’s overall score or that of individual products. Clicking on a supplier’s RegiScore opens a detailed report of the factors impacting their score as well as the number of shipments the supplier has had of each product in the past 5 years.
“RegiScore is an invaluable tool for both quality assurance and procurement professionals. It puts a wealth of actionable data at the user’s fingertips,” said Registrar Corp president David Lennarz. “Knowing sooner and acting faster – that’s what the monitor is all about.”
Empowering importers to think like FDA
When Registrar Corp developed the FDA Compliance Monitor, they had the FDA in mind. FDA uses a Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to determine which imports to examine or sample upon arrival to the United States. It allows FDA to release low risk and consistently compliant products more quickly and prioritize higher risk shipments for closer inspection.
PREDICT is a proprietary government software, and FDA’s evaluations are not publically available. One of Registrar Corp’s goals for RegiScore is to make a similar supplier assessment available to Monitor users in order to help importers make informed buying decisions. Like PREDICT, RegiScore analyzes companies and products based on their compliance history and quantity of shipments.