Guide
What is an L4 hub?
L4 is the corporate system that receives partner EPCIS, matches what arrived, ships with transaction data, and keeps evidence for an inspector. It is not plant-line software and not a national regulatory gateway.
Serialization vendors talk about L3, L4, and L5. The labels matter because buyers often purchase a global network when they needed a warehouse workspace, or a PDF portal when they needed an event hub.
L3 is plant and packaging-line software. It commissions serials, aggregates cases, and authors commissioning events. TracePharma does not replace your line. It can forward authored commissioning EPCIS to an L3 endpoint you already run.
L4 is your corporate hub. Partner files arrive. Clerks scan. Exceptions open. Outbound EPCIS ships with transaction information, history, and statement. Verification runs where your profile requires it. That is TracePharma’s job for US DSCSA.
L5 is a national or regional regulatory hub (for example an EU FMD country gateway). TracePharma does not operate L5. US DSCSA does not require you to join a global L5 network to talk to partners you already know.
Where TracePharma fits
Your plant runs L3 line software. TracePharma is the L4 corporate hub—EPCIS, partners, and compliance. National hubs (L5) stay outside our product; we connect your trading partners.
-
L3
Plant serialization
Line controllers, commissioning — software you already run
-
L4
TracePharma
EPCIS repository, partner connectivity, exceptions, compliance workflows
-
L5
National / regulatory hubs
FDA, EMVO, country hubs — not TracePharma; partners may connect upstream
What electronic DSCSA actually requires
Trading partners must exchange interoperable transaction data for serialized product and keep records you can produce. In practice that means EPCIS events, not a PDF archive. An ASN can drive the dock. It is not a substitute for EPCIS. Read EPCIS vs ASN.
What you do not need
You do not need an enterprise network to receive partner files, match the dock scan, verify where required, and hand an inspector a package. You do not need to replace line software to run L4. You do not need global modules for a US-only partner list.
See L4 on a profile-tuned workspace
Beginner agenda: partner files in, match what arrived, exceptions, evidence. We reply within one business day.
30–45 minutes on a profile-tuned workspace. We reply within one business day.