Case Study: ISI Group, LLC achieves FDA 21 CFR Part 11 validation with FileHold

ISI Group, LLC - Customer Case Study

ISI Group, a small virtual developer of medical image management software, needed a document management system that would support FDA-regulated electronic records and signatures (21 CFR Part 11) while remaining affordable and easy for users to adopt. Faced with many products and mixed vendor claims about compliance, they prioritized systems that met their intended-use requirements, kept costs under control, and offered high usability.

After evaluating 15 systems and shortlisting FileHold and NextDocs, ISI chose FileHold for its lower cost, simpler implementation, and better usability. They validated the system using a formal protocol (defining intended use, requirements, and risks), vendor documentation, user training, and a traceability matrix to map controls to regulatory needs. The result was a defensibly validated document management solution that met their regulatory and operational goals, reduced implementation overhead, and produced repeatable validation artifacts they can streamline for future upgrades.

ISI Group, LLC