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The latest on DSCSA compliance and the EU FMD: How UniTrace® simplifies serialization and traceability

May 9, 2025
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By Jim Waters
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“Another shipment hold.”

The midnight text message joins a week’s worth of similar alerts on your phone. By morning, 3 deliveries sit in limbo, their products unable to move forward. What began as occasional paperwork issues has evolved into persistent headaches, with compliance exceptions now consuming valuable team hours and creating bottlenecks throughout your distribution network.

Look at any pharma supply chain in 2025, and you’ll see the same story. Our latest benchmark report, “Unlocking value in supply chain track & trace solutions,” found 41% of pharma companies wasting countless hours on manual rework, while 31% highlighted data exchange errors as a top concern.

And that’s precisely what our UniTrace® track & trace solution aims to solve.

Error-handling realities: DSCSA and EU FMD in 2025

Whether you’re dealing with EPCIS data errors or shipping delays, the day in the life of a pharma supply chain professional in 2025 isn’t easy. That’s why, regardless of where you are in the world, exception management and handling determines if products move or money burns.

DSCSA deadlines and exception nightmares

The clock is ticking loudly for DSCSA compliance deadlines. These staggered timelines give you breathing room to fine-tune exception handling—but they’re also creating chaos between trading partners at different stages.

Your operation faces a daily gauntlet of common exception scenarios.

  • Shipments arriving without data (“Product, No Data”) trigger immediate quarantines, halting processing
  • Incorrect data entry creates mismatches between physical goods and system records, requiring significant reconciliation work
  • Barcode scanning mishaps force “stop-ship” commands that freeze operations entirely

Meanwhile, walk through any distributor warehouse and spot the growing “quarantine zones” built for exception handling. Manual rechecks drive labor costs skyward while FDA warning risks loom.

EU FMD: False alerts and more

The Windsor Framework (from 2023) officially came into effect in January 2025 and now haunts your EU operations. Northern Ireland’s UKNI system disconnection from the EU Hub means UK packs flowing through Europe trigger constant alerts: “Market not found”- #A22. “Batch not found”- #A2. “Unknown product code”- #A1. And unlike technical glitches, these political exceptions demand manual resolution.

False alerts still drain resources daily. March 2024 EMVO data shows false alert rates between 0.16% and 1.17% across seven countries—better than the early 6% rates but nowhere near the 0.05% target. Add in the 4.67% of cases triggering incorrect quarantines during offline authentication, and your error management team never catches a break.

Greece and Italy are approaching EU FMD implementation (with Italy getting a two-year extension until 2027), but the promised standardized protocols for handling suspected falsifications remain fragmented across member states. Your team juggles different alert handling rules for each country while the European Commission’s standardization efforts move at bureaucratic speed.

How UniTrace simplifies pharmaceutical serialization and traceability

Ever found yourself explaining to executives why $2 million in product is stuck in quarantine over a barcode error? That’s where our tried-and-true UniTrace track and trace solution comes into play to simplify serialization and traceability.

  • Your supply chain’s early warning system: UniTrace track and trace solution spots trouble before it happens. Bad GTINs and mismatched master data get caught during upload, not when products hit a distribution center. Your phone stays quiet, your warehouse keeps moving, and your blood pressure thanks you.
  • One system, all regulations: Ditch those region-specific platforms eating up your IT budget. UniTrace track and trace solution handles all global regulations, such as DSCSA and EU FMD through a single interface, automatically translating between their requirements. Your team learns one system, not five—and those Windsor Framework headaches? Handled automatically.
  • Fix problems where they happen: Why run back to your office when an alert pops up? UniTrace mobile puts resolution power in your hand right on the warehouse floor. Scan the problem package, clear the exception and move the product in minutes instead of hours.
  • Aggregation without the aggravation: Remember when “parent-child relationships” meant family therapy, not pallet configurations? UniTrace track and trace solution automates hierarchy tracking from packaging line to delivery, eliminating those maddening “where’s the data?” moments that freeze entire shipments.

Serial thriller: How UniTrace turns compliance chaos into calm

Honestly? Sometimes it feels like pharma serialization is paying a fortune for the privilege of creating your own problems. But UniTrace flips that equation with real results: Fewer alerts, faster resolutions and products that move instead of sitting quarantined. There’s a reason why Systech is trusted by 85% of the top 20 global pharmaceutical companies.

Contact Systech today and join the companies that have stopped dreading compliance.

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