Cell & Gene Therapy Supply Chain Tracker

Function Specialized vein-to-vein logistics and compliance platform managing chain of custody, chain of command, and cryogenic monitoring for cell and gene therapies.
Challenge Complex vein-to-vein compliance tracking
Impact Audit-ready vein-to-vein record

Challenge

A cell and gene therapy supply chain required end-to-end tracking from patient apheresis through manufacturing and back, with strict regulatory compliance (FDA 21 CFR 1271, FACT/JACIE, EU GMP Annex 16, DSCSA) at every handoff.

Approach

Scimitar built a specialized platform with complete digital chain of custody (timestamp, GPS, signatures), enforced chain of command authorization hierarchies, real-time cryogenic temperature monitoring with automated excursion alerts, and 21 CFR Part 11-compliant e-signatures at every release and transfer checkpoint.

Impact

The client achieved a fully digital, audit-ready vein-to-vein record with zero unmonitored handoffs and automated regulatory compliance reporting.

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