Case Study: International Health Agency improves medical product oversight with ArkCase

International Health Agency Promotes Regulatory Collaboration and Safer Medical Products with Alfresco-Based Platform

An international health agency sought to improve the safety and oversight of medical products by creating a secure platform for regulatory collaboration among its member states. They partnered with ArkCase, using its case management platform on top of the Alfresco Digital Business Platform, to build the Regulatory Exchange Portal (REPs) for sharing non-public documents.

ArkCase, integrated with Alfresco, provided the solution with document management, workflow, and a configurable user interface. The platform automated processes, ensured a secure, auditable chain of custody for documents, and specifically supported the Medical Device Single Audit Program (MDSAP). This allowed over 100 auditors and regulators to share and analyze audit information efficiently, leading to faster, more informed decisions and improved regulatory alignment.