DSCSA in the US. FMD in the EU. One verification layer.
Aeroz adds cryptographic unit identity and sub-60-second recall traceback on top of TraceLink, Antares Vision, and MediLedger — closing the operational gaps serialization leaves open. No rip-and-replace.
A GS1 2D barcode can be photographed and reprinted. A cloned code scans as "valid" — the weakness EU FMD's design does not close on its own.
Under DSCSA, returned product must be verified before resale. Carton-level data can't prove a specific unit is the original.
When a lot is recalled, reconstructing unit-level custody from disconnected systems is slow — and patients stay exposed in the meantime.
Aeroz adds unit-level authentication, saleable-returns verification, and sub-60-second recall traceback on top of your serialization stack — mapped to Section 582 of the FD&C Act (21 U.S.C. § 360eee-1) and EPCIS 2.0.
The Falsified Medicines Directive mandates a 2D barcode and tamper-evidence — but a 2D code can be cloned. Aeroz binds an AES-128 chip identity to each pack, so a counterfeit with a copied barcode fails the authentication check.
We don't fight the barcode — regulators require it. We anchor it. The GS1 2D barcode carries the regulated data; the Aeroz chip carries cryptographic identity. Clone the barcode and the chip check fails; remove the chip and the seal voids.
| Attack | 2D barcode alone | NFC / UHF chip | Aeroz paired |
|---|---|---|---|
| Photograph & reprint | Cloned | Resists | Fails counterfeit |
| Tamper / refill | Invisible | Seal voids | Seal voids |
| Bulk dock verification | Line-of-sight | UHF at distance | UHF at distance |
| Regulated data carrier | GTIN, lot, expiry | Identity only | Both, bound |
| Offline durability | Smudge / tear | Sealed IC | Redundant |
Every verification — where, when, pass or fail — on the append-only log.
Each handoff (dock → ship → receive → dispense) as an EPCIS 2.0 event.
Armed or breached, per unit, the moment it changes.
Temperature and shock excursions for sensitive biologics.
First-scan geography exposes grey-market routes before they spread.
Form 3911 and unit-level custody, generated from the same log in seconds.
A fixed-fee Aeroz audit produces a written gap analysis against DSCSA §582 or EU FMD, an EPCIS-readiness assessment of your stack, and a scoped remediation plan with cost and timeline.
