Registrar Corp’s FDA Compliance Monitor now includes RegiScore, a patent pending risk evaluation tool that calculates compliance scores for non-US 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 two hundred 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.
“The FDA Compliance Monitor tool is a great product that allows us to quickly and effectively evaluate current and potential suppliers,” said Stephanie Billings, Regulatory Compliance Manager for The TJX Companies. “The Registrar Corp team has been an invaluable resource for all our FDA related inquiries.”
About the FDA Compliance Monitor
The FDA Compliance Monitor automates supply chain risk management by checking suppliers daily for compliance issues, and immediately alerting users when anything changes. The software acts as a single source of truth, centralizing key supplier data in one simple, secure dashboard.
The Monitor was originally launched in 2016 as a Foreign Supplier Verification Program (FSVP) compliance tool for the food industry. FDA’s FSVP rule mandates US food importers to monitor and document their foreign suppliers’ compliance, including identification of any import alerts or warning letters related to food safety. The Monitor archives monthly compliance status reports, allowing importers to easily meet FSMA monitoring and documentation requirements.
“Using the Monitor is by far the best tool for FSVP monitoring,” said Jamie Jones, Director of European Operations at La Tienda, a large importer and online retailer of Spanish food products. “This is especially true when you consider the speed, cost, and accuracy when compared to staffing someone in-house.”
Today the Monitor is being used by hundreds of importers of food, drugs, devices, and cosmetics to better monitor their suppliers. To learn more about the FDA Compliance Monitor and how it can help you minimize risk, schedule a demo or visit www.registrarcorp.com/compliance-monitor