DSCSA · SNI · EPCIS 1.2 · Interoperable exchange
DSCSA software with EPCIS exchange for trading partners — SNI, aggregation, verification, saleable returns.
Manufacturers, repackagers, wholesale distributors, and dispensers under the Drug Supply Chain Security Act. Serialized Numerical Identifier (SNI / GTIN + serial + lot + expiry) on every saleable unit, aggregation to homogeneous and mixed cases and pallets, EPCIS 1.2 event exchange with trading partners, verification and saleable-returns workflow — all on a Part 11 backbone, not a bolted-on serialization box.
SNI on Every Saleable Unit
Aggregation, Cases + Pallets
EPCIS 1.2 Event Exchange
Verification (VRS)
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You're shopping because the serialization box the CMO installed in 2019 doesn't do interoperable exchange.
Standalone L3/L4 serialization system doesn't share data with QMS or ERP
Aggregation is incomplete — cases and pallets don't consistently roll up unit data
EPCIS files fail trading-partner ingestion because of schema drift
Suspect / illegitimate product investigations run in email
Repackaging events don't cleanly rewrite aggregation
DSCSA, run as one interoperable spine.
SNI on Every Saleable Unit
GTIN + serial + lot + expiry printed, verified, and bound to the batch record. Reject/reprint flows without breaking the aggregation tree.
Aggregation, Cases + Pallets
Homogeneous and mixed-case aggregation, pallet aggregation, and re-aggregation on rework or repackaging — the tree stays consistent across the plant.
EPCIS 1.2 Event Exchange
Object, Aggregation, Transaction and Transformation events with the ILMD, BizStep, disposition and source/destination structure trading partners expect.
Verification (VRS)
Verification Router Service integration with sub-250 ms responses, saleable-returns workflow, and audit trail on every lookup.
Suspect / Illegitimate Product
Investigation workflow with FDA Form 3911 support, quarantine, and notification to trading partners in the required window.
Repackaging + Relabelling
New SNI assignment, source-SNI decommission, and rebuilt aggregation tree — with full audit trail to the original manufacturer serial.
What changes the day this goes live.
- Aggregation tree survives from line to trading partner without drift
- EPCIS files ingest cleanly on the first try with wholesale distributors
- Verification returns under 250 ms and saleable returns clear same-shift
- Suspect product investigations run inside the QMS, not in email
- Repackaging rebuilds aggregation with full traceback to source SNI
The frameworks a serialization lead owns.
DSCSA (Interoperable Era)
Serialized transaction information, transaction history and transaction statement exchanged electronically and interoperably with trading partners — including the enhanced stabilization exemptions and phased enforcement policies.
GS1 EPCIS 1.2 + CBV 1.2
Object, Aggregation, Transaction and Transformation events with Core Business Vocabulary — the format the US pharma ecosystem standardised on.
GS1 SGTIN / SSCC
Serialized GTIN for saleable units, Serial Shipping Container Code for cases and pallets — encoded per GS1 General Specifications.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — software controls that support your Annex 11 approach; validation and procedures remain yours.
DSCSA software, answered.
Do we still need DSCSA compliance after the FDA stabilization period?
Yes. The FDA's stabilization periods delayed enforcement but did not change the underlying requirements. Manufacturers, wholesale distributors and dispensers must operate to the interoperable data-exchange model. Exemption status differs by trading-partner type and continues to change (FDA listed a new small-business-dispenser exemption on 6 August 2026), so check FDA's current DSCSA waivers, exceptions and exemptions page for your category.
What is aggregation and why does it matter?
Aggregation is the parent-child relationship between a serialized case (SSCC) or pallet and the SGTINs inside it. Without aggregation, every downstream partner has to open every case to verify contents — which defeats the purpose of unit-level serialization.
How does V5 handle EPCIS exchange?
V5 emits and ingests EPCIS 1.2 events (Object, Aggregation, Transaction, Transformation) with CBV 1.2, with the ILMD, BizStep, disposition and source/destination structure trading partners require. Ingestion validation surfaces schema drift before it becomes a partner-relationship issue.
Does V5 support the Verification Router Service?
Yes. VRS integration returns verification responses under 250 ms and drives the saleable-returns workflow with a full audit trail on every lookup.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Stop running serialization as a standalone box.
Free trial. Real EPCIS, real aggregation, real VRS.