Track and Trace

Track and trace describes the capability to follow a product's journey from raw material through production, distribution, sale and (when relevant) end-of-life. Track-and-trace combines two perspectives. Tracking: where is this specific item now? Tracing: where has this item been, and what other items shared its path? For ERP-bearing organisations in regulated industries (pharma, food, medical devices, automotive), track-and-trace is the operational backbone of compliance and recall capability.

How track-and-trace works

Three foundational elements. (1) Unique identification: every traceable unit (item, case, pallet) carries a unique identifier — serial number, batch lot, GS1 GTIN with serial number. (2) Event recording: every relevant transformation (production, packaging, shipment, delivery, sale, return) is recorded against the unit identifier with timestamp, location, actor and event type. (3) Genealogy graph: relationships between units (raw materials to finished goods, components to assemblies, batches to retail packs) form a queryable graph that supports forward tracing (which products contain this affected lot) and backward tracing (what raw materials went into this finished item). The data volumes can be substantial: a pharma manufacturer with 100,000 packs per day generates millions of trace events per year.

Regulatory drivers

Track-and-trace is rarely voluntary. Major regulatory drivers in DACH-relevant industries. Pharma: EU Falsified Medicines Directive (FMD) mandates unique-identifier serialisation for prescription drugs since February 2019, with verification at dispense. EMVO and national systems (NMVS) provide the verification infrastructure. Medical devices: MDR and US FDA UDI require device traceability through production and supply chain. Food: EU General Food Law (Regulation EC 178/2002) requires 'one step back, one step forward' traceability for all food businesses. Automotive: IATF 16949 and OEM-specific requirements drive component-level traceability for warranty and recall. Tobacco: EU Tobacco Products Directive track-and-trace. Textile: forthcoming EU Digital Product Passport.

ERP integration

Track-and-trace touches ERP at multiple points. Master data: traceable unit definitions (item, batch, serial-number policy) configured in the ERP material master. Production: shop-floor data collection or MES integration captures the batch-genealogy events. Inventory: batch and serial number tracking in warehouse transactions. Sales and distribution: delivery documents carry batch and serial information. Returns and recalls: the ability to search by batch or serial to identify affected transactions and trigger recall workflows. Major ERP products handle these capabilities natively for industries where track-and-trace is a known requirement; specialist platforms (Antares Vision, TraceLink, Optel, rfXcel) provide deeper capabilities for pharma serialisation, FMD compliance and aggregation that exceed typical ERP scope.

Practical implementation

Three patterns for successful track-and-trace deployment. (1) Match granularity to requirement. Pharma serialisation at individual-pack level is mandated; food traceability at batch level usually suffices. Over-granular tracking creates operational burden without business benefit. (2) Integrate with shop-floor systems. MES, weighing systems, packaging-line scanners produce the trace events at source. ERP integration must capture these in real time, not via end-of-shift reconciliation. (3) Test recall scenarios. The value of track-and-trace shows under recall pressure; if the system cannot produce affected-product lists within hours, the investment was misplaced. Annual recall-simulation exercises validate the end-to-end capability before regulators or quality events do.

Related Topics

• Audit trail
• ERP for pharma
• ERP for food