Track and Trace Software

At Experion Technologies, we help enterprises implement track and trace software that delivers real- time visibility, proper integration and operational efficiency across global supply chains.

According to the US Food and Drug Administration, around 4,500 medical devices and drugs are recalled from US shelves every year. As per the Regulatory Affairs Professionals Society (RAPS), U.S. pharmaceutical product recalls have increased significantly in recent years. The reasons are numerous, ranging from manufacturing defects and mislabeling to packaging defects. The real challenge lies in the complexity of executing recalls efficiently.

This is where track and trace software becomes a lifesaver.

The software answers critical questions: Where is the product right now? Can you verify where it’s been?  Can you act quickly on where it is headed before the damage escalates?

Its value is not limited to just recalls. The organizations getting real value from track and trace technology are using it to catch problems in advance and build supply chain visibility that batch-level inventory data simply can’t provide.

 

Key Takeaways

• Track and trace software operates at the individual, serialized-unit level, not at the batch or SKU level. That granularity is what enables targeted recalls and product authentication.
• Pharma track and trace software is shaped by hard regulatory deadlines: DSCSA in the US, EU FMD in Europe, and market-specific mandates in India, Brazil, and China.
• Automated traceability software cuts recall costs by narrowing scope. This includes every unit shipped in a quarter, with specific serial numbers and locations.
• Choosing the right track and trace solution requires an honest assessment of your regulatory footprint and internal validation capacity.
• The best track and trace software delivers data beyond compliance: serialization yield trends, exception patterns, and supply chain visibility that improve daily operations.

 

What is Track and Trace Software?

Supply chain visibility used to mean a paper trail.

This might be a batch number on a box, a signature on a delivery note, or even a filing cabinet nobody wanted to search during an emergency. Track and trace software replaces that paper trail with a digital one that’s searchable in real time across every tier of the supply chain.

The concept splits into two functions: Tracking a product unit through distribution and tracing it back to its origin. The system assigns a unique identifier to each unit at manufacture, records events as the product moves through the chain, and makes that history available for audit at any point in the chain.

This differs from standard inventory or ERP tracking, which works at the batch or SKU level. Track and trace work at the item level.

For example: Instead of knowing 10,000 units left your warehouse in March, you know that a serialized unit SN-00482917 left your facility on March 14th, was received by distributor Y on March 17th, and was dispensed at pharmacy Z on March 22nd. That specificity changes what’s possible in a recall or a regulatory inspection.

Serialization is the foundation. Each product unit has a unique identifier. This is typically a 2D DataMatrix barcode or an RFID tag that encodes the GTIN, batch number, and expiry date.

 

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How Track and Trace Software Works?

The process starts at the packaging line and ends at the point of consumption. Here’s what happens at each stage.

• Serialization assigns a unique serial number to each product unit. This can be printed as a 2D DataMatrix barcode or encoded on an RFID tag, alongside the GTIN, batch number, and expiry date. This dataset travels with the unit throughout the entire supply chain.
• Aggregation links individual units to their parent containers: bottles to cartons, cartons to cases, cases to pallets. Scan a pallet barcode, and the system resolves every unit inside it. Aggregation helps avoid scanning each individually. The parent-child hierarchy makes downstream warehouse handling efficient.
• Event capture records what happens to the product at each handoff. Handoffs at each stage include Commissioning, shipping, receiving, transfer of ownership, returns, and decommissioning. These events are all stored in EPCIS (Electronic Product Code Information Services) format (the GS1 standard for supply chain event data) in a centralized repository that authorized parties can query at any time.
• IoT sensors help add environmental data, such as temperature, humidity, and location. This data is necessary for cold chain or high-value shipments.
• Cloud platforms handle storage and processing at the scale required by multi-site, multi-country operations.
• Verification at the end of the line is automated. Performed via camera-based code inspection and rejection mechanisms. Thus, the data entering the system is accurate before the product leaves the facility.

 

Essential Features of Track & Trace Software

Core Technical Capabilities

What the system must do to function in a regulated environment:

• Serialization and aggregation: Generates and manages unique serial numbers at item, case, and pallet levels. Handles aggregation hierarchy and disaggregation workflows when cases are broken down at a distribution point.
• Repository and verification integration: Connects with regulatory repositories and trading partner systems to facilitate seamless EPCIS event exchange, while enabling real-time product verification at the point of dispense.
• Exception management and alerts: Detects, logs, and routes exceptions. These exceptions include damaged codes, aggregation errors, and verification failures. Exceptions can be resolved with configurable resolution workflows. A system that flags exceptions without capturing why they occurred gives operators nothing useful to work with.
• Multi-site, multi-country support: Manages different serialization formats, regulatory rules, and submission interfaces for each market from a single platform.
• Compliance management and reporting: Produces audit-ready reports, maintains complete event history, and generates regulatory submissions in required formats.
• ERP/MES/WMS integration: Pulls master data from ERP and writes serialization results back. Without this, you’re maintaining parallel systems that will drift apart and create exceptions at the line.

What Separates Good Systems from Enterprise-Grade Ones?

These are the capabilities that matter when you’re buying for a multi-site, multi-market operation and not a pilot:

1. Real-time visibility across the full supply chain: Not just within your facility. Across distributor tiers, down to the point of dispense. Without this, you’re managing exceptions reactively instead of catching them before they become compliance events.
2. Interoperability across stakeholders: The ability to exchange data with manufacturers, 3PLs, pharmacies, and regulators using standard formats. A system that operates in isolation is a serialization database, not a track and trace system.
3. Scalability under load: Can the platform handle peak volume across all sites simultaneously? What happens to availability during a high-volume campaign? These are questions worth getting SLA commitments on.
4. User interface and workflow design: Packaging line operators who can’t quickly resolve an exception will create workarounds or stop the line. Intuitive interfaces and clear exception workflows reduce human error in ways that training alone can’t fix.
5. Cybersecurity: Serialization repositories hold sensitive product and batch data. Enterprise-grade systems provide encryption at rest and in transit, zero-trust access controls, and GDPR-compliant handling of any personally identifiable information in the event stream.

 

Types of Track and Trace Systems

The right track and trace technology depends on your product, your supply chain structure, and your regulatory environment.

• Barcode-based systems (1D and 2D):The most widely deployed option in regulated industries. 2D DataMatrix barcodes are compact square barcodes that encode data vertically and horizontally. This allows it to hold more data than a traditional linear barcode. Global compliance regulations mandate this barcode system since it encodes a full GS1 data string in a small footprint.
  1. Advantage: Cost-effective and compatible with most existing packaging lines.
  2. Limitation: Line-of-sight scanning is required, and code quality degrades when printing or labeling equipment isn’t properly maintained.
• RFID-based systems: RFID tags can be read without line of sight and handle multiple items simultaneously. It is well-suited for pallet and case-level tracking in warehouse and logistics environments.
  1. Advantage: Most practical in distribution centers, cold chain logistics, and high-value product categories.
  2. Limitation: Per-unit cost is significantly higher than for printed barcodes, limiting item-level RFID adoption in high-volume pharmaceutical manufacturing.
• GPS-enabled tracking: GPS tracks shipments or containers, not individual products. It adds a geographic context, i.e., real-time location for cold chain monitoring, last-mile verification, and cross-border visibility. It complements serialization rather than replacing it.
• Blockchain-based traceability: A blockchain creates an immutable, shared ledger of supply chain events. This is useful when multiple parties need to verify the same record without depending on a single central authority.
  1. Advantage: The strongest practical use cases are in complex multi-party supply chains, such as fresh produce, pharmaceutical wholesaling, and high-value cross-border shipments.
  2. Limitation: Blockchain records what was logged accurately, not whether it was true. A counterfeit product that gets serialized and committed to the chain stays there.
• Cloud-based vs on-premise solutions

Feature	Cloud-Based	On-Premise
Deployment speed	Faster	Slower
Upfront cost	Lower	Higher
Validation burden	Shared with vendor	Fully internal
Data sovereignty	Vendor-dependent	Full control
Regulatory updates	Vendor-managed	Internal responsibility
Best for	Mid-market, multi-site	Large enterprise, strict data residency

Cloud-based architectures are the clear trend, but in regulated industries, “cloud-first” still needs to comply with regulatory requirements and data residency rules in markets like the EU and China.

 

Benefits of Implementing Track and Trace Solutions

• Improved supply chain transparency: When every unit has a unique identifier, and every handoff is recorded, you can see where the product is sitting across distributor tiers. That visibility reduces inventory write-offs from expired or misrouted stock, which most companies currently underestimate because they can’t see it.
• Enhanced product safety and recall management: Item-level serialization lets you identify exactly which units came from an affected batch and where they are in the distribution network. Recall scope goes from “every unit we shipped in Q3” to “487 serial numbers currently in three distribution centers.” The difference in cost and logistics is significant.
• Regulatory compliance : Companies with mature track and trace systems don’t treat DSCSA audits or EU FMD inspections as emergencies. The event data exists in the system, is structured correctly, and is easily queryable. Companies running incomplete systems spend weeks before each inspection reconstructing records that a proper system would have maintained automatically.
• Reduced counterfeiting : If your serialization system does not commission a unit, it fails the point-of-dispense verification check. It gets flagged as an exception before it reaches the patient or end consumer. Several manufacturers have used authentication event data to identify diversion networks operating inside their own distribution channels.
• Operational efficiency : Serialization data surfaces packaging line inefficiencies that aren’t visible in any other data source. High rejection rates on a specific line point to equipment issues- a worn printhead, a camera calibration drift- before they cause a production stoppage. Companies that treat track and trace data as operational intelligence, rather than just compliance records, typically see a 15–25% improvement in serialization yield within the first year.
• Better customer and partner trust: Retailers, hospital systems, and pharmacy chains are increasingly making serialization capability a condition of supplier contracts. Being able to answer “where has this product been?” in real time is no longer just a regulatory requirement in some industries- it’s becoming a commercial one.

 

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Pharma Track and Trace Software: A Category Apart

Pharmaceutical serialization is not like other regulated software deployments. The mandates are very specific, the enforcement is real, and the penalty for non-compliance isn’t a fine. It could mean losing the ability to sell the product in that market.

H3 | Regulatory Drivers in Pharmaceutical Track and Trace

• DSCSA (Drug Supply Chain Security Act): The DSCSA is a US-based regulation. It requires pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers to serialize at the unit level and exchange EPCIS-formatted transaction data. EPCIS is a standard format for sharing supply chain events between companies. Full interoperability requirements took effect in 2023, with active FDA enforcement following.
• EU FMD (Falsified Medicines Directive): Requires 2D DataMatrix serialization on all prescription medicines sold in Europe and point-of-dispense verification through NMVS (National Medicines Verification) systems. The EU Unique Identifier encodes data such as product code, serial number, batch number, and expiry date.
• Other markets: India’s SUGAM, Brazil’s SNCM, China’s NMPA requirements, and Turkey’s ITS each have distinct formats and submission interfaces. Companies selling globally need a platform that handles all markets through market-specific configuration, rather than separate systems for each country.

What Pharmaceutical Track and Trace Software Must Do?

The pharmaceutical track and trace software must enable

• Serialization at the item, case, and pallet level with correct GS1 Application Identifiers for each market. GS1 application identifiers are standardized prefixes used in bar codes. This is done to structure data such as product codes, serial numbers, batch details, and expiry dates.
• Integration with National Medicines Verification Systems (NMVS) for EU market verification.
• Master data alignment: GTIN, batch, expiry, and serial number consistency with ERP
• Aggregation and disaggregation workflows with full audit trail
• Exception handling for damaged codes, aggregation breaks, and verification failures

Its biggest impact lies in patient safety. Pharmaceutical track and trace software prevents counterfeit drugs from entering the legal supply chain by verifying each unit against the manufacturer’s serialization records at the point of dispensing. A unit that doesn’t match gets flagged and quarantined before it reaches the patient.

Another widespread application is in recall management. A functioning track and trace system compresses the timeline from “quality event identified” to “affected units located and quarantined” from weeks to hours.

That difference has direct implications for patient safety and regulatory penalty exposure.

Track and Trace System for Pharma Packaging

Line integration is where most projects hit their first real friction. Pharmaceutical packaging lines run fast. Their rate can sometimes reach 400+ units per minute. The track and trace system has to keep pace without creating a bottleneck. Some examples include:

• Labeling Equipment Integration: Inkjet printers, laser coders, and label applicators connected to the serialization engine.
• Camera-based vision systems that inspect every printed code and trigger rejection for unreadable or failed codes
• Reject conveyors and downtime management workflows that keep production moving when exceptions occur.
• Artwork and label management integration to ensure correct data elements appear in the right format for each target market.

Experion brings deep expertise in packaging line integration, serialization architecture, and regulatory compliance, enabling pharmaceutical companies to deploy robust track and trace systems that perform reliably at production scale.

Industry Applications Beyond Pharma

Food and Beverage

The FDA’s FSMA Rule 204 requires companies handling high-risk foods to maintain item-level traceability records with specific data elements: Lot codes, unit quantity, and location. The operational payoff is a more targeted recall.

This level of traceability is crucial in preventing large-scale supply chain failures. A well-known example is the 2013 Horsemeat scandal in Europe. Mislabeled beef products were found to contain horse meat. Due to limited overall visibility, it was difficult to identify the source and scope of contamination.

With proper track and trace software, if a contamination is identified, you can pull specific lots from a specific production run on a specific date.

Medical Devices

UDI (Unique Device Identification) requirements mandate serialized labeling on most medical devices and registration in the FDA’s central repository.

Track and trace for medical devices also supports post-market surveillance. When a field safety corrective action is needed, the system identifies which specific serial numbers went to which hospitals, rather than triggering a broad recall across an entire product family.

Logistics and Third-Party Logistics (3PLs)

3PLs handling pharmaceutical products are increasingly required to capture and pass on EPCIS transaction data as a condition of their distribution agreements. Companies that can’t do this are being cut from supplier networks.

Beyond compliance, last-mile visibility(documented proof that a temperature-sensitive product was delivered intact, to the right location, at the right time) is growing rapidly in specialty pharma and direct-to-patient distribution.

Consumer Electronics and High-Value Goods

Serialization for consumer electronics, luxury goods, and automotive parts is primarily a commercial decision rather than a regulatory one. The goal is to prevent diversion and counterfeiting that erode brand value and create warranty liability. Authentication event data can identify diversion networks operating inside distribution channels before they reach a scale that affects revenue.

 

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How to Choose the Best Track and Trace Software for Your Business?

The right starting point isn’t “which platform is best”- it’s “what do we actually need this system to do?”

Which markets are you selling into, and which regulations apply in each? A manufacturer shipping to the US and EU faces materially different compliance requirements than one operating across 15 markets, including China, Brazil, and Turkey.

What is your role in the supply chain? A primary pharmaceutical manufacturer has different DSCSA obligations than a CMO, a repackager , or a wholesale distributor. Your role determines your specific requirements.

What is your current serialization maturity?

Starting from zero is a different project from replacing a legacy system two months before a compliance deadline. Being honest about your starting point shapes your timeline, budget, and who makes your shortlist.

Must-Have Criteria When Evaluating a Track and Trace Solution

• Regulatory coverage: Does the system maintain current compliance for every market you sell into? Ask about the vendor’s regulatory update cycle and how quickly changes are implemented.
• Integration capability: How does it connect to your specific ERP version, your MES, and your packaging line equipment? Customer references running similar technology stacks are more useful than architecture diagrams.
• Scalability: Can it handle your peak serialization volume across all sites simultaneously? Get specific SLA commitments on availability during high-volume production campaigns.
• Validation support: In a GxP environment, processes must meet “good practice” standards. You need Installation Qualification (IQ) /Operational Qualification (OQ) /Performance Qualification (PQ) documentation, and a vendor who understands the process. If validation is new territory for your vendor, it will become a project risk.
• Vendor industry experience: Track and trace is not a standard software deployment. The people implementing it need to understand packaging operations, regulatory submission processes, and what line integration actually looks like at production speed.

Common Mistakes When Selecting Track and Trace System Software

• Scoping for one market: Companies that implement a particular geographic (eg: DSCSA) compliance without considering others (Eg: EU FMD ) often end up rebuilding or extending their system within 2 years.
  Future-proof the architecture even if you’re currently selling into a single market.

• Underestimating line integration: The packaging line work is typically the longest and hardest part of the project. It should get its own budget line and timeline estimate.
• Skipping the proof of concept: Vendor demos use clean data and controlled conditions. A POC with your actual ERP connection, your actual master data, and your actual line configuration tells you something real.
• Not planning for validation overhead: In regulated environments, validation effort often equals or exceeds implementation effort. Companies that leave this until the end run out of time before the regulatory deadline.

 

Implementation Roadmap: What a Track and Trace Rollout Actually Looks Like

Most track and trace projects that go over budget do so for predictable reasons. The software is rarely the problem.

Phase 1 – Gap assessment and regulatory scoping: What do you have, what does each target market require, and what’s missing? This phase also surfaces integration complexity across your serialization system, ERP, and packaging lines.

Phase 2 – System selection and architecture design: Based on the gap assessment, which platform, which integration approach, how master data flows, how EPCIS events are generated, and where they go.

Phase 3 – ERP/MES/line integration: This is the most important phase. It involves connecting the serialization engine to ERP for master data and event write-back. It also includes connecting to packaging line PLCs for real-time printing and verification. This phase typically accounts for 40–60% of the total project effort.

Phase 4 – UAT, validation, and regulatory submission support: User acceptance

testing must be performed using real batch data. This is followed by the execution of

the IQ/OQ/PQ protocol to meet compliance requirements. Finally, connectivity testing

is performed with regulatory systems such as NMVS for the EU and DSCSA trading

partner exchange for the US.

Phase 5 – Go-live and hypercare: Production deployment involves going live with the

system while closely monitoring key metrics, such as serialization yield, exception

volumes, and EPCIS transmission success. The first few production campaigns will

surface issues that testing didn’t catch. Having experienced support available during

hypercare prevents those issues from becoming compliance events.

 

Challenges in Implementing Track and Trace System

• High initial costs – The software license is rarely the largest line item. Packaging line modifications combined with GxP validation and production downtime during cutover are usually where budget pressure builds. Companies that budget for software and underestimate line integration routinely run 30–40% over their original project estimate.
• Serialization yield and line performance– Track and trace software is responsible for detecting, logging, and categorizing every rejected unit at the line. A system that flags rejections without capturing the reason gives operators nothing actionable. Good track and trace software captures rejection reason codes, tracks trends by line and product, and surfaces that data so engineering teams can distinguish a hardware issue from a software configuration problem.
• Validation overhead in regulated environments- Every software update to your track and trace system triggers formal change control and revalidation. Vendors who don’t provide pre-validated change packages or who push frequent, uncontrolled updates create a compliance backlog that grows with every release cycle. When evaluating platforms, ask specifically: Do you deliver pre-validated change packages for regulatory updates, or does our team rebuild the validation documentation each time?
• Integration complexities with legacy systems-Connecting a serialization engine to an ERP not designed for serialization creates friction at every data boundary. GTIN mismatches, batch structures that don’t map cleanly, and expiry date formats that differ between systems generate exceptions at the line. The fix requires dedicated data governance work before go-live.
• Data management issues – A multi-site, multi-market deployment generates significant serialization event data. Systems that weren’t architected for this volume hit performance and availability walls as deployments expand. Storage, archiving, and retention policies should be built into the architecture from day one.
• Regulatory challenges- Each market has its own submission interface and enforcement timeline. The platform needs to be able to handle market-specific configurations centrally; otherwise, you end up with parallel systems.
• Resistance to change at the operational level: Line operators who’ve worked without track and trace solutions tend to view them as a source of downtime rather than a compliance tool.

That perception isn’t entirely wrong. In fact, poorly implemented systems do cause stoppages. Changing it requires technical reliability first (systems that perform consistently at production speed) and visible management commitment to the rollout.

 

Future Trends in Track and Trace Technology

• Blockchain Integration: Blockchain has emerged as an enhancement to the “tracing” factor. This is especially true in complex multi-party supply chains. By using immutable ledgers, blockchain enables the tamper-proof recording of supply chain events. This is valuable in industries such as pharmaceuticals and food, where chain-of-custody verification is essential. The effectiveness of blockchain still depends on the quality of data captured at the point of serialization.
• AI and Predictive Analytics: Most companies currently use their track and trace data for compliance reporting and exception response. Applied analytics on that same data can predict supply chain bottlenecks before they occur, identify exception patterns indicating systemic process failures, and surface authentication anomalies suggesting diversion activity.
• Sustainability: Brands are under pressure to substantiate “sustainable sourcing” and “ethical manufacturing” claims. They are using track and trace infrastructure to document product provenance at the product level. This is not just for regulators, but for procurement teams and consumers. In food, retail, and consumer goods, verified supply chain provenance is becoming a contract requirement, not just a marketing claim
• IoT-enabled smart tracking – Smaller sensors are making it practical to attach temperature, humidity, shock, and location data to individual, serialized units. For cold chain pharmaceuticals and high-value electronics, that granularity changes what’s provable in a damage claim or a quality investigation.

 

ConclusionbIn recent years, track and trace software has become mandatory in the pharmaceutical and food industries. In most other regulated sectors, the question is no longer whether to implement it, but whether to do it on your timeline or the regulator’s.

The companies getting the most from these systems are the ones treating them as operational infrastructure rather than compliance overhead.

Serialization yields data that improves line efficiency. Authentication analytics that identify diversion before it becomes a brand problem. Recall response times measured in hours rather than weeks. These are outcomes that justify the investment on their own, before you factor in audit readiness.

The right system depends on your regulatory footprint, your technology landscape, and your capacity for validation and change management. Getting clear on those questions before you talk to vendors is what separates a successful implementation.

 

With proven experience across regulated industries, Experion partners with organizations to design, implement, and optimize track and trace solutions that are future-ready, compliant, and built for global expansion.