Organizations working toward DSCSA compliance put significant effort into data preparation, EPCIS testing, and coordination with trading partners. Yet many of the exceptions that arise during commissioning, aggregation, shipping, or receiving often trace back to something more practical: the serialization labels applied on the packaging line.
The identifiers printed on these labels anchor each product’s electronic record. When a label remains consistent with the commissioned data and scans cleanly throughout handling, EPCIS events process with fewer interruptions. When it does not, discrepancies appear as unknown serial numbers, hierarchy mismatches, or verification delays—issues that take far longer to resolve than they do to detect.
With DSCSA’s enhanced security requirements now in effect and trading partners exchanging serialized data electronically, label accuracy has a direct impact on how EPCIS-based workflows function.
This post looks at:
DSCSA requires each saleable unit to carry a 2D DataMatrix barcode with a product identifier containing the GTIN or NDC, serial number, lot number, and expiration date. In pharma serialization, this label links the physical item to the commissioned record that drives EPCIS events.
Serialization teams already understand these requirements. The challenge is maintaining alignment between:
When alignment breaks at any point, discrepancies tend to surface later—often after the packaging run is complete and the product has moved downstream.
Serialization labels become unreliable when the physical and digital workflows fall out of sync. The sections below focus on the operational conditions that cause discrepancies.
Commissioning establishes the unique serial numbers for each GTIN, but the packaging line must pull the correct data at the correct time. Misalignment often results from:
A DataMatrix may be readable while still carrying outdated or incorrect content. That discrepancy surfaces later, not at the line.
Packaging conditions can degrade label readability or placement:
Vision systems may catch gross errors but not subtle inconsistencies. A label that scans at the line may fail at case-level aggregation or distributor receiving under different lighting or angles.
Aggregation relies on consistent capture of unit-level DataMatrix codes. Issues arise when:
These gaps create EPCIS hierarchy mismatches downstream.
At distribution centers, receiving systems validate incoming serialized data against what is scanned physically. When label data does not align with the EPCIS shipment record, receiving workflows slow down and often require manual review.
What makes these exceptions difficult is not only the delay itself, but the uncertainty around root cause. From the distributor’s perspective, it is rarely clear whether the issue stems from commissioning, aggregation, EPCIS mapping, or labeling upstream.
Resolving the discrepancy typically involves multiple parties reviewing data after the fact, long after the packaging run has ended.
In many cases, these receiving issues trace back to inconsistencies introduced on the packaging line, even though they first appear downstream during EPCIS verification.
DSCSA’s enhanced security requirements rely on EPCIS as the standard format for electronic data exchange between trading partners. EPCIS 1.2 is widely used for DSCSA compliance and provides the structure for recording product movement through commissioning, aggregation, shipping, receiving, and decommissioning.
As serialized product data moves between manufacturers, distributors, and dispensers, EPCIS serves as the shared interface that allows each party to interpret and verify that data consistently.
EPCIS functions as the point where upstream serialization and labeling decisions become visible across the supply chain. Every EPCIS event references the identifiers printed on serialization labels. When those identifiers remain aligned with commissioning and aggregation data, product movement data can be exchanged and verified without intervention. When they do not, EPCIS becomes the place where earlier inconsistencies surface.
Common EPCIS-related issues tied to label misalignment include:
These conditions slow downstream operations and are often difficult to resolve because the EPCIS event no longer reflects a single system or owner, but a shared record spanning multiple trading partners.
For this reason, EPCIS reliability depends not only on message formatting or system connectivity, but on the integrity of the serialized identifiers applied to each saleable unit.
Serialization programs often use fragmented architectures in which:
Each handoff introduces an opportunity for drift.
Typical failure modes in fragmented workflows include:
Even when every individual step is managed by competent operators, the ecosystem itself allows for misalignment.
The core issue is not labeling equipment, per se, but data coherence across systems.
Once serialized product data enters EPCIS workflows, the same identifiers are reused and validated repeatedly as products move across organizations. In a U.S. pharmaceutical supply chain that includes tens of thousands of dispensing locations, multiple national distributors, and high daily prescription volumes, a single unit-level inconsistency rarely remains isolated.
After leaving the packaging line, the same serialized identifiers are referenced through:
When label data, commissioning records, and EPCIS events remain aligned, these interactions proceed without added intervention. When they do not, the same discrepancy can surface multiple times across different systems and partners, increasing the operational effort required to resolve it.
Many labeling inconsistencies originate from architectures where commissioning, printing, aggregation, and EPCIS creation occur in separate systems. Covectra’s AuthentiTrack platform reduces these issues by managing those steps within a single, coordinated framework.
Key differences from traditional workflows include:
By reducing the number of systems involved, AuthentiTrack limits opportunities for data drift between labeling, commissioning, aggregation, and EPCIS exchange. The result is a workflow in which physical labels and serialized records remain aligned as products move downstream.
Many DSCSA exceptions require time-consuming investigation because their origin is difficult to pinpoint once product has moved downstream. Addressing labeling and data alignment at the packaging line reduces that investigative burden across trading partners and systems.
To learn more about how Covectra supports consistent label and data alignment across DSCSA workflows, contact our team to discuss your serialization needs.
Serialization labels carry the product identifiers that DSCSA requires at the saleable unit level. Those identifiers are referenced throughout commissioning, aggregation, shipping, receiving, and verification workflows. If label content does not match the commissioned data or aggregation structure, downstream EPCIS events may fail validation even when systems are functioning correctly.
Serialized identifiers are created on the packaging line but reused across multiple downstream events. Receiving and verification systems compare scanned label data against expected EPCIS records. When inconsistencies exist, they become visible at those checkpoints, even if the contributing issue occurred earlier during printing or aggregation.
Yes. A DataMatrix barcode may scan cleanly while containing outdated or incorrect data. Vision systems typically verify readability, not whether the printed identifier matches commissioning records or aggregation hierarchies. Those mismatches are often detected later during EPCIS validation.
When printed labels, commissioned serials, aggregation records, and EPCIS events originate from the same coordinated data source, discrepancies are less likely to propagate downstream. This reduces the need for multi-party investigations across manufacturers, distributors, and dispensers when exceptions occur.
Read More
Serialization in Pharma: Driving Compliance, Safety, and Traceability
EPCIS and DSCSA: How Serialization Supports Compliance
What Is Pharmaceutical Serialization and Why Is It Critical Today