Track and Trace

The process of assigning a unique, machine-readable identifier to each saleable unit, case, or pallet. This digital birth certificate, often encoded in a GS1 2D Data Matrix barcode, contains the Global Trade Item Number (GTIN), serial number, lot, and expiration date. Serialization transforms a generic SKU into a traceable asset, forming the absolute foundation for compliance with regulations like the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD).

The logical linking of unique identifiers to define a packaging hierarchy. When a case is packed, its unique SSCC (Serial Shipping Container Code) is scanned and associated with the serial numbers of the individual units inside. This creates a parent-child relationship, allowing a warehouse operator to scan a single outer case barcode and instantly know the precise identity and history of every item contained within, without breaking the seal.

The physical act of scanning a serialized barcode at the point of production or repackaging to activate the identity in a repository. A commissioning event is the first 'birth record' for a serial number, capturing the what, when, and where of manufacturing. This requires high-speed machine vision cameras on packaging lines capable of reading 2D codes at rates exceeding 500 units per minute, with automated rejection systems for unreadable or duplicate codes.

The standardized data store that records all Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as a product moves. Based on the GS1 EPCIS (Electronic Product Code Information Services) standard, this repository captures the 'what, where, when, and why' of every supply chain event—from commissioning and shipping to receiving and dispensing. It serves as the single source of truth for constructing a digital pedigree.

The point-of-dispense or point-of-use check that confirms a product's authenticity and active status. Before a pharmacist dispenses a drug or a mechanic installs a part, a barcode scan queries a national verification system (like the EMVS in Europe) or a brand owner's repository. The system responds with a binary 'verified/not verified' signal, ensuring the item is not counterfeit, expired, recalled, or previously dispensed, effectively decommissioning the serial number.

The secure, peer-to-peer sharing of serialization data between trading partners without a central database. Using GS1 Lightweight Messaging Standard for Verification of Product Identifiers, systems query authorized sources directly. This federated architecture preserves data ownership and confidentiality while enabling a brand owner to instantly respond to a verification request from a hospital on the other side of the world, closing the traceability loop.

The process of assigning a unique identifier to each saleable unit of a product, typically via a 2D Data Matrix barcode containing the Global Trade Item Number (GTIN), serial number, lot, and expiration date. This digital identity is the foundational prerequisite for track and trace, enabling pedigree verification and preventing counterfeit infiltration. Without serialization, granular traceability is impossible.

An immutable, distributed digital record used to create a tamper-proof, shared audit trail of all custody transfers and environmental conditions across multiple stakeholders. In track and trace, blockchain eliminates the need for a central trusted authority by providing a single source of truth that is cryptographically verifiable, preventing retroactive alteration of shipment records and enabling automated smart contract execution.

A digital record that aggregates a product's entire lifecycle data, including its cold chain custody history, manufacturing origin, and carbon footprint, into a single, shareable, and verifiable identity. Mandated by emerging EU regulations, the passport provides end consumers and regulators with transparent access to a product's complete provenance and sustainability credentials via a simple scan.

The United States Food and Drug Administration (FDA) regulation that establishes the criteria for accepting electronic records and electronic signatures as equivalent to paper records. For track and trace systems, this mandates rigorous controls including secure, computer-generated audit trails, operational system checks, and authority checks to ensure that digital chain-of-custody documentation is legally defensible.

The FDA's Food Traceability Rule that establishes additional recordkeeping requirements for foods on the Food Traceability List (FTL). It mandates the capture and sharing of Key Data Elements (KDEs) at specific Critical Tracking Events (CTEs)—such as harvesting, cooling, packing, and receiving—enabling rapid identification and removal of contaminated food from the supply chain to protect public health.