On August 27, 2025, HELM successfully brought our pharmaceutical clients live with the DSCSA Serialization Module, ensuring full compliance with the FDA’s requirements for tracking prescription medications at the serial number level.
From Lot to Serial-Level Tracking
Until now, many humanitarian and nonprofit organizations tracked pharmaceuticals by item, lot, and expiration date. With HELM’s new serialization capabilities, clients can now extend visibility down to the individual bottle of medicine, unlocking a new level of precision and safety.
Seamless Data Exchange & Validation
HELM supports the receipt and validation of serialized data through EPCIS XML files provided by donors and manufacturers. At the warehouse level, teams can scan:
• Pallet or carton SSCC labels,
• Individual bottles,
to ensure every serialized unit is accounted for from the very first point of receipt.
Managing Complex Supply Chain Flows
Serialization introduces new challenges in humanitarian logistics—and HELM meets them head-on. New features in both HELM and our Android scanner apps support:
• Aggregation & de-aggregation of data as pallets are broken down into cases and bottles,
• Flexible order picking processes that adapt to multi-level shipping, overpacking, and unique pick/pack/ship combinations.
End-to-End Traceability
As always, HELM ensures complete visibility and traceability from manufacturer to last-mile recipient. With DSCSA Serialization now fully embedded, our clients can confidently meet compliance standards while safeguarding the integrity of life-saving medicines.