Pharmaceutical traceability software is often evaluated on compliance checkboxes: does it generate serial numbers, does it produce EPCIS events, does it satisfy DSCSA recordkeeping. Real operations ask more of it. Consider what a manufacturer needs when:
These are the moments that reveal whether traceability software was built for the full scope of pharmaceutical supply chain operations, or just for the audit.
DSCSA compliance sets the floor: serialize at the saleable unit, generate EPCIS events, retain transaction records for six years.
Operations ask for more. Pharmaceutical traceability software has to perform across several distinct layers at once:
Each layer has its own failure points, and each is where "compliant on paper" and "workable in operations" tend to diverge.
Serial number generation and event capture happen at line speed, which means software has no room for latency or manual re-entry. A capable system:
Manufacturers running multiple packaging lines, or working through contract packagers, need this captured consistently across every site. Inconsistent capture at the line is often where downstream EPCIS data problems originate.
EPCIS is the GS1 standard the FDA recognizes for DSCSA transaction data exchange.
What current software should support:
What slows this down:
The Healthcare Distribution Alliance's EPCIS benchmarking survey found that manufacturers and distributors consistently ranked these as their top obstacles:
Technology limitations ranked lower. Software that speeds up onboarding and simplifies exception handling addresses the part of the process that slows partners down most.
Why the timing matters now:
Enforcement has caught up with the requirements. Manufacturers were required to comply by May 27, 2025, wholesale distributors by August 27, 2025, and large dispensers' enhanced requirements took effect November 27, 2025. Broader pharmacy compliance is due by November 2026. Software that simplified onboarding during the original rollout continues to support partners still catching up.
Aggregation, linking individual units to the cases and pallets they're packed into, is where data integrity is easiest to lose and hardest to recover. If a case-to-pallet association breaks, the traceability chain breaks with it.
Software built for real operations should:
Aggregation accuracy is what makes a recall precise instead of overbroad. Strong aggregation data lets a manufacturer confirm exactly which units, cases, and pallets are affected, and pull only those.
DSCSA requires six years of transaction data retention and, for returned product entering the resale stream, verification against the original transaction history before it can be resold. Software should support:
Automated verification keeps returns processing fast and gives manufacturers a clear, auditable record of every check performed.
Most pharmaceutical manufacturers aren't implementing traceability software into a blank environment. They're layering it onto ERP systems, warehouse management systems, and line-level control systems that already run the business.
This is frequently where implementations succeed or stall, depending on how well the software fits into what's already there. Software designed for integration should:
Taken together, these requirements point to a straightforward evaluation question: does the software handle the full operational path, from the packaging line to the trading partner to the returns desk, or only the compliance reporting at the end of it?
Covectra's AuthentiTrack platform is EPCIS certified and supports a serial event history repository for complete supply chain traceability. It's available in two configurations, depending on operational need:
Combined with Covectra's pharmaceutical serialization services, manufacturers get both the software and the implementation support to connect it into existing operations.
Serialization software focuses on generating and printing unique identifiers at the packaging line. Traceability software includes that function but also covers EPCIS data exchange, aggregation management, and the recordkeeping needed to trace a product's full chain of custody.
Not directly in every case. A gateway-style configuration can handle messaging format differences between a manufacturer's system and a trading partner's, so each new partner doesn't require a custom integration.
It checks a returned product's identifiers against the original transaction history to confirm the item is legitimate and eligible for resale, a requirement under DSCSA before returned product can re-enter the supply chain.
Yes, though this is where many implementations run into friction. Software built to support multiple CMOs or CPOs, each potentially running different systems, needs standardized data handling that doesn't depend on every partner using identical infrastructure.
Incomplete aggregation data forces a broader recall than necessary, since the system can't confirm exactly which units, cases, or pallets are affected. Accurate aggregation narrows a recall to what's genuinely implicated.
Evaluating traceability software against a checklist only goes so far. The real test is how it performs against your actual packaging lines, trading partner mix, and returns volume.
A Serialization Review looks at where your current systems handle these requirements well, where gaps exist, and what a fuller AuthentiTrack implementation, whether Cloud Level 5, Gateway, or both, would look like for your operation.
Request a serialization review to see how AuthentiTrack would fit your current packaging and trading partner environment.