Case Study: ARC-One achieves record-fast, FDA-ready QMS launch and regulatory compliance with ComplianceQuest

ARC-One Achieves Quality, Regulatory, and Safety Goals with ComplianceQuest’s Market-Leading QHSE

ARC-One, a software medical device manufacturer that tracks donated blood from collection to transfusion, faced the urgent challenge of deploying a fully functioning quality management and health & safety system before opening day while being 100% ready for any FDA inspection. To meet tight timelines and strict regulatory needs, ARC-One selected ComplianceQuest’s cloud-based Enterprise Quality and Safety (QHSE) management system built on the Salesforce platform.

ComplianceQuest implemented its QHSE solution—using out-of-the-box document, training, change control, nonconformance, CAPA, complaints (including FDA XML reporting), and supplier modules—on an accelerated schedule, cutting end-user validation time and replacing paper routing with electronic workflows. As a result, ComplianceQuest helped ARC-One meet every milestone and launch on schedule in April 2020 with FDA-ready processes, improved supplier oversight, faster reporting, and streamlined cross‑team collaboration.

ARC-One

Jared McDonley

Director of Regulatory Affairs and Quality Systems