Serialized DSCSA tracking, cold-chain logging with excursion alerts, and audit trails ready for FDA, DEA, or state-board review. Every scan timestamps and attributes to a named operator.
Every industry has its quirks. Here are yours.
We've mapped the operational quirks of pharmaceuticals & medical against Nautilus capabilities. Each challenge here pairs with how we handle it.
Serialization mandates
DSCSA and EU FMD require unique serial numbers on every unit. Manual tracking is impossible at scale, and the penalty for failure is exclusion from the supply chain.
Serial number tracking
Scan and verify individual serial numbers. Nautilus maintains the complete chain of custody for every unit, with EPCIS file generation for outbound shipments.
Cold chain integrity
Temperature excursions can destroy millions in inventory. You need proof that storage conditions were maintained, not just a claim.
Cold chain logging
Integrate with temperature monitors. Nautilus logs conditions continuously and alerts immediately on excursions, with reports ready for credit conversations.
Regulatory audits
FDA, DEA, and state boards can audit at any time. Your records need to be complete, accurate, and producible on demand.
Audit-ready reports
Generate complete audit trails in seconds. Every scan, movement, and adjustment is timestamped and attributed to a named operator, with the retention period the regulator requires.
From dock to door.
Every action a pharmaceuticals & medical warehouse takes, mapped to a Nautilus flow — running on phones, tablets, or rugged scanners.
Serial receipt
Each unit's serial number scans and reconciles against the supplier's EPCIS file. DSCSA chain of custody begins at the receiving dock.
Cold-zone putaway
Temperature-monitored zones with continuous logging. Excursions alert before product damage occurs, not after.
Chain-of-custody pick
Pick lists honor lot, expiration, and custody requirements. Substitutions block unless explicitly authorized by a named approver.
Verified pack & manifest
Second scanner verifies the pack. EPCIS outbound file generates; tamper-evident seals apply with audit log entry.
What customers see.
Averages across Pharmaceuticals & Medical customers in their first 12 months.
Pharmaceuticals & Medical questions, answered.
The questions buyers in pharmaceuticals & medical ask before they sign. If yours isn't here, the team can answer it on a discovery call.
Is Nautilus DSCSA compliant?
Yes. Nautilus handles DSCSA serialized product tracking, lot/batch verification, EPCIS file generation for outbound shipments, and the 6-year transaction history retention requirement. We also handle the November 2023 DSCSA enhanced drug distribution security (Phase II) requirements including verification-on-receipt for suspect product. Customers can self-attest using our DSCSA report; for FDA inspections, we generate the trace audit on demand.
How is HIPAA handled for medical-device customers?
Nautilus is HIPAA compliant and signs a BAA. Inventory data for medical devices doesn't typically contain PHI directly, but customer order data sometimes does (patient name, procedure, facility). We treat order data as PHI by default for medical-device customers: encrypted at rest, role-based access, and audit log of every read.
Can we generate EPCIS files for outbound shipments?
Yes. EPCIS 1.2 and 2.0 file generation is built in. Outbound shipments to wholesalers and dispensers include the full ASN/EPCIS payload with serial numbers, lot information, and chain of custody. We've tested compatibility with the major DSCSA-compliant trading partners (McKesson, Cardinal, AmerisourceBergen) and the smaller regional wholesalers.
What about temperature-excursion proof for high-value cold-chain shipments?
Each cold-chain shipment carries continuous temperature data from the in-package data logger, stored against the shipment record. Excursion alerts fire to a configured pager list at the moment they happen. If a wholesaler or hospital pharmacy claims an excursion on receipt, Nautilus can produce the in-transit temperature history within seconds, usually settling the credit conversation before it becomes a dispute.
See Nautilus running in a pharmaceuticals & medical warehouse.
Live demo with a warehouse engineer. 30 minutes. We bring the data, you bring the questions.