Traceability in pharma: The end-to-end supply chain story

In Part 1 of our series, we established serialization as the foundational step, providing each pharmaceutical unit with a unique digital identity. Part 2 then introduced aggregation, demonstrating how these serialized units are efficiently grouped into logical hierarchies for streamlined handling. Now, in this final installment, we connect the dots—traceability.

Traceability is the “big picture” of every product’s journey through the supply chain, powered and enabled by the granular data from serialization and aggregation. It’s the ultimate mechanism for transparency and accountability, providing answers to critical questions about a product at any point in time.

What is traceability? Unveiling the product journey

At its core, traceability provides comprehensive visibility into a product’s movement and history. It can answer crucial questions like:

• Where is the product right now? (Current location)
• Who handled it at each step? (Chain of custody)
• Has it been stored under proper conditions? (Temperature, humidity, etc. – often linked to data loggers)
• Is this specific unit authentic and safe to dispense? (Verification against legitimate data)

Traceability can be implemented in various ways to serve different needs:

• Forward traceability: Tracking a product from its manufacturing origin down through the supply chain to dispensing.
• Backward traceability: Tracing a product back from its point of dispensing to its manufacturing origin.
• Real-time tracking: Monitoring product movement as it happens.
• Retrospective investigations: Analyzing historical data to understand past events (e.g., for recalls or audits).

The primary purpose of traceability is multifaceted and vital for patient safety and regulatory compliance:

• Immediate detection and isolation: The ability to swiftly identify, detect and isolate suspect or recalled products from the supply chain.
• Regulatory compliance: Satisfying stringent regulatory reporting requirements, such as the DSCSA mandate for fully electronic, interoperable traceability by November 27, 2025.
• Comprehensive audit trails: Providing verifiable records for regulatory inspections and quality assurance.

Enabling traceability: Beyond the packaging line

To achieve true end-to-end traceability, you need systems that extend beyond the packaging line. This involves a Level 4 (L4) system, which centrally manages serial number provisioning, storage and communication with the L3 line-level systems. Systech’s UniTrace® is a prime example of such an L4 system.

While UniTrace can be deployed with any L3 solution, the profound benefit of integrating UniTrace with Systech’s UniSeries® L1-L3 solution is the vastly simplified exception management between the IT environment (L4) and the Operational Technology (OT) environment on the packaging lines (L1-L3). Exceptions are common—whether on the packaging line, in warehouses where products are shipped or returned or within the “digital” tracking environment of L4. A unified L1-L5 solution minimizes complexity and significantly lowers costs by streamlining exception resolution.

Finally, to exchange information with supply chain partners, support for industry standards becomes not just important, but required. This is the domain of a Level 5 (L5) system. Key standards include:

• GTIN (Global Trade Item Number): A GS1 standard enabling unique identification of trade items, ensuring a shared understanding of what is being shipped.
• EPCIS (Electronic Product Code Information Services): A GS1 standard defining a common data model for “visibility data” (status, location, movement and chain of custody of physical packages) and interfaces for sharing this data across the supply chain.

It’s a known challenge that, like many data standards, no two implementations of EPCIS 2.0 are exactly alike. This variability can create exceptions and make it difficult to change trading partners or system vendors once integrations are established. Systech has engineered its cloud-based L4-L5 solution (UniTrace) to provide customers with full flexibility, making it easier to integrate with new business partners without extensive reconfigurations.

Furthermore, ensuring you are dealing with legitimate entities is paramount. This requires a mechanism to verify Authorized Trading Partners (ATP). To be considered an ATP, trading partners must be registered and compliant with regulatory bodies, such as the FDA. Systech’s Authorized Trading Partner (ATP) solution, with its network of 80,000 accredited partners, facilitates efficient and error-free accreditation within the pharmaceutical supply chain.

When a full-stack L1-L5 solution from Systech is deployed, the internal time spent investigating returns or verification failures at the IT level is dramatically reduced. You can quickly and reliably trace which packaging site, line, pallet, carton or even a single unit of package went to which customer, often within seconds. This unparalleled level of visibility is simply impossible if you rely on fragmented, IT-only systems that lack deep integration with line-level operations.

How serialization, aggregation and traceability work together for compliance

Real-world scenario: The integrated advantage

Imagine a pharmaceutical manufacturer utilizing Systech’s complete ecosystem:

1. Line inspection & serialization: Every blister pack is automatically printed with a Datamatrix code. Systech’s integrated vision inspection camera instantly verifies code legibility and placement, rejecting any non-compliant units in real-time.
2. Aggregation: These perfect blister packs are then aggregated into cartons. Each carton’s unique ID is captured and tied back to all underlying pack IDs. These cartons are then aggregated into pallets, each receiving its own serial number, with all associations verified on the line.
3. Traceability & reporting: As pallets ship to wholesalers, Systech’s cloud platform (UniTrace) records every transaction, capturing the chain of custody. Distributors report DSCSA transactions directly to the manufacturer’s database, ensuring seamless data flow. Pharmacies can then authenticate products at the point of dispensing using the serialized data.

Later, if a suspect lot is identified, the manufacturer can immediately query the aggregated and traced data. Within moments, they can determine precisely which pallets were sent to which distribution centers, which pharmacies received them and the ultimate destination of each package. This level of precision, only possible when serialization, aggregation and traceability are fully integrated, significantly drives down risk, minimizes recall costs and, most importantly, keeps patients safe.

Beyond compliance: Advanced anti-counterfeiting

While L1-L5 systems are fundamentally designed for traceability for every serialized unit of packaging, enhancing security, and improving recall capabilities, it’s crucial to understand their limitations regarding counterfeiting. The DSCSA, for instance, focuses on tracking and tracing legitimate prescription drugs. It helps validate authenticity but does not completely remove the risk of counterfeit drugs, especially when sophisticated counterfeiters replicate valid serial numbers.

The EU FMD goes a step further than DSCSA by requiring safety features like anti-tamper packaging in addition to unique product identifiers. For EU-FMD compliance, all serialized data is sent to a centralized EU data repository. When a unit is dispensed, its serial number is verified and then discarded from the active pool, preventing reuse. DSCSA, by contrast, operates on a federated network of supply chains.

However, both compliance programs share a common vulnerability: they don’t explicitly address scenarios where counterfeiters apply a currently valid serial number to a fake package. This is where Systech truly differentiates itself. In addition to providing a full-stack L1-L5 solution for robust traceability, Systech equips pharmaceutical brands with multiple layers of cutting-edge anti-counterfeiting technologies. Our e-fingerprinting capability, through solutions like Systech UniSecure® and ArtAI™, creates globally unique digital signatures for labels or even the full artwork of the package. This allows for real-time authentication of the packaging itself, providing an unparalleled defense against even the most sophisticated counterfeits, irrespective of the serial number’s validity.

The bottom line

Serialization, aggregation and traceability are distinct but fundamentally interdependent elements of a modern pharmaceutical supply chain.

• Serialization assigns a unique digital identity to each product unit.
• Aggregation ties multiple identities together across packaging levels for efficient handling.
• Traceability leverages the combined data to monitor and verify products across the entire supply chain.

Together, they form the bedrock of modern pharma compliance and patient safety. At Systech, we don’t just sell isolated software or hardware components. We deliver fully integrated, end-to-end solutions—because, without the operating-technology layer that connects the physical world to the digital, a “serialization” system is truly just code on a screen. By combining high-speed line inspection, secure serialization printing, robust aggregation workflows, cloud-based traceability and advanced anti-counterfeiting measures, Systech empowers manufacturers, distributors and dispensers to meet today’s regulations head-on and prepare for tomorrow’s demands with unmatched confidence and security.

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