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Track and Trace Software for Pharma: Features, Requirements, and Compliance Readiness

By Covectra | Posted on November 24, 2025

A shipment is ready to leave a packaging line. Serial numbers have been assigned, aggregation data is complete, and EPCIS files must be exchanged with trading partners before the product can move. Downstream, a wholesaler prepares to receive the shipment and verify that the identifiers match the data they expect to see. At the end of the chain, a pharmacy must confirm product authenticity at the point of receipt.

Every step relies on accurate, traceable data. Most DSCSA requirements are now in effect across manufacturers, repackagers, and wholesale distributors, and only one phase remains: smaller dispensers (25 or fewer full-time employees) have until Nov. 27, 2026. As the pharmaceutical supply chain moves through these final stages, organizations are evaluating whether their systems can reliably generate, exchange, and reconcile serialized event data.

This post outlines how pharmaceutical track and trace software supports DSCSA compliance and supply-chain continuity. We’ll cover:

What “track and trace software” means in a pharmaceutical context
How it differs from warehouse or ERP tracking
Features needed to support DSCSA
How trading partners use these systems
What to consider when evaluating platforms

What ‘Track and Trace Software’ Means in a Pharma Context

The phrase “track and trace” is used across many industries, but in pharmaceuticals it has a specific meaning shaped by DSCSA and global serialization regulations. These systems manage:

Saleable unit level serialization
Aggregation of cases and pallets
EPCIS event generation and exchange
Verification and response
Documentation required for inspections
Event lineage across manufacturers, 3PLs, wholesalers, and dispensers

Unlike general-purpose tracking tools, pharmaceutical track and trace software is built to manage the identifiers, data structures, and workflows required for regulated products.

How Pharma Track and Trace Differs From Warehouse or ERP Tracking

Warehouse management and ERP systems track inventory movement, location, and fulfillment activities. They are not designed to ensure whether each saleable unit is legitimate, verified, and supported by accurate event data.

Pharma track and trace platforms must align serialized identifiers with:

Commissioning events
Packing and aggregation
Shipment and receipt
Verification requests
Returns and investigations

Instead of simply recording where a product is, these systems document whether the product is authentic and whether its associated data meets regulatory standards.

Why DSCSA Shapes the Requirements

DSCSA defines how prescription drugs must be serialized, verified, and traced as they move through the supply chain. Each phase of implementation introduces new expectations for how trading partners generate, exchange, and manage event-level data. With the November 2025 dispenser milestone, the focus has shifted to whether downstream partners can support verification and accurate data exchange.

Requirements Now in Effect for Upstream Trading Partners

Readiness varies across the supply chain. According to Regulatory Focus, wholesalers reached a median data-exchange accuracy rate of 98.5%. Requirements for manufacturers and repackagers took effect on May 27, 2025, and these trading partners now operate under the fully implemented serialization and data-exchange provisions of DSCSA.

Dispensers Still Have Work to Do

Verification at the point of receipt remains an area with room for progress among dispensers, according to Pharmaceutical Commerce. Many pharmacies are still adjusting their workflows and systems to support serialized identifiers, event histories, and exceptions handling—especially those incorporating the new requirements into established operations.

Ongoing Gaps Highlight the Role of Software

Pharmaceutical Commerce also noted FDA discussions emphasizing the need for stronger interoperability and more efficient handling of incomplete or mismatched data during the stabilization period. These observations directly influence what trading partners need from track and trace platforms, including:

Consistent EPCIS exchange with multiple partners
Reliable reconciliation of mismatches
Support for verification workflows
Clear event histories for inspections

As the remaining DSCSA phases take effect, software helps trading partners maintain accurate, usable serialized data across manufacturers, wholesalers, 3PLs, and dispensers.

Core Features of Pharma Track and Trace Software

Pharma track and trace systems share common capabilities designed to support downstream compliance, upstream production, and collaboration across the supply chain.

Serialization Management

Assigning unique identifiers at the unit, case, and pallet levels, including support for GS1 standards and regulatory data structures.

Line Integration

Connecting with packaging lines and printers to commission serial numbers and support changes in packaging formats.

Aggregation

Linking units to cases and pallets, maintaining parent–child relationships that must remain accurate as products move through facilities.

EPCIS Event Management

Creating, storing, and exchanging EPCIS 1.2 or EPCIS 2.0 event data for commissioning, packing, shipping, receiving, and decommissioning.

Verification Routing

Receiving and responding to verification requests, including product identifier checks for dispensers and wholesalers.

Exception Handling

Addressing mismatches in serial numbers, incomplete event histories, or errors that must be resolved before products can move.

Partner Connectivity

Exchanging EPCIS data with contract manufacturers, wholesalers, 3PLs, and dispensers, ensuring that each partner receives accurate files.

Role-Based Access and Audit Trails

Maintaining controlled access to sensitive data and documenting activities for inspection readiness.

Recall Support and Investigation Tools

Retrieving event histories to support recalls and investigations, allowing organizations to trace when and where issues occurred.

Compliance Readiness Across the Supply Chain

DSCSA requirements apply differently to manufacturers, wholesalers, and dispensers, which shapes how each group uses track and trace software.

Manufacturers and Repackagers

Manufacturers handle serialization commissioning, aggregation, and most EPCIS event creation. Their systems must support packaging line integration and high-volume event generation for shipments to multiple trading partners.

Wholesale Distributors

Distributors receive large volumes of serialized data and must verify product identifiers when accepting, returning, or investigating products. With high throughput, wholesalers rely on accuracy and interoperability to move products without delays.

As noted by Regulatory Focus, distributors reported a median data-exchange accuracy rate exceeding 98% leading up to the Aug. 27, 2025 deadline, following the extended DSCSA stabilization period provided by the FDA.

Dispensers

Pharmacies and health systems verify product identifiers at the point of receipt. Pharmaceutical Commerce has identified this step as a continuing weak point for DSCSA compliance, requiring accurate event data provided by upstream partners.

Dispensers with 26 or more full-time employees must comply with DSCSA serialization and verification requirements by Nov. 27, 2025, extending the law’s provisions further downstream in the supply chain.

Choosing a Pharma Track and Trace Platform

Selecting a track and trace system involves assessing how well the platform supports regulatory requirements and collaboration with trading partners.

Key considerations include:

Interoperability: Support for EPCIS 1.2 and EPCIS 2.0, plus compatibility with a broad partner network.
Accuracy Controls: Tools for identifying mismatches, missing events, or inconsistencies.
Exception Management: Workflows for resolving data gaps before products move downstream.
Event Lineage: Ability to reconstruct product histories quickly for audits or investigations.
Scalability: Capacity to handle growing serialization volumes and multiple packaging lines.
Data Governance: Role-based access, audit trails, and documentation support.
Support for Multiple Trading Partners: Integration with contract manufacturers, 3PLs, wholesalers, and dispensers.

Key Takeaways

A platform that supports these capabilities helps organizations maintain compliance and supply-chain continuity.

1. Pharma track and trace depends on event-level accuracy.

DSCSA workflows require systems that manage serialized identifiers and the full sequence of commissioning, packing, shipping, receiving, and verification events—not just inventory movement.

2. Variability in readiness shapes interoperability needs.

Upstream partners operate under requirements already in effect, while downstream partners—especially dispensers—are still adapting to serialized event data, making consistent EPCIS exchange essential.

3. Verification on receipt remains a developing area.

Industry updates show ongoing work to support verification at the dispenser level, reinforcing the need for tools that can handle exceptions, mismatches, and incomplete data as products move downstream.

How Covectra Supports Pharma Track and Trace

Covectra’s AuthentiTrack platform is an example of a system used for serialization management, aggregation, EPCIS event generation, and verification support. It helps trading partners exchange serialized data and maintain traceability across the pharmaceutical supply chain, supporting workflows required under DSCSA.

Interested in learning more?

Frequently Asked Questions About Track and Trace Software

What’s the difference between serialization and track and trace?

Serialization assigns unique identifiers to individual saleable units, while track and trace systems manage the event data associated with those identifiers as products are commissioned, packed, shipped, received, verified, or decommissioned.

Do all trading partners need to exchange EPCIS data under DSCSA?

EPCIS is the format used for sharing serialized event information under DSCSA. Manufacturers, repackagers, wholesale distributors, and many dispensers rely on EPCIS files to document product movement and verification.

How does track and trace software support verification on receipt?

Verification tools compare the product identifier on a package against the serialized event data received from upstream partners. This helps dispensers confirm whether a product can be accepted, investigated, or returned.

What happens if serialized data does not match during receiving?

Mismatches may trigger exceptions that must be resolved before products move downstream. Track and trace systems help identify missing events, incorrect identifiers, or aggregation issues so trading partners can correct them.

Is track and trace the same as warehouse management or ERP tracking?

No. Warehouse and ERP systems track inventory locations and movements. Track and trace software manages serialized identifiers and the event histories required for DSCSA compliance and product verification.