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Track and trace

Track and trace refers to the systematic process of monitoring and recording the movement, location, and status of products or goods throughout the entire supply chain, from raw materials or manufacturing origin to the final consumer, enabling real-time visibility and verification to enhance security, efficiency, and regulatory compliance.^[1]^[2] This methodology is foundational to modern supply chain management, addressing the complexities of global trade by providing end-to-end transparency that mitigates risks such as counterfeiting, theft,^[3] and contamination.^[1] Key technologies underpinning track and trace include barcodes for identification, radio-frequency identification (RFID) for automated data capture, GPS for location tracking, and emerging solutions like Internet of Things (IoT) sensors and blockchain for secure data sharing.^[4]^[5]^[6] Standards organizations like GS1 play a pivotal role by establishing interoperable global protocols, such as the GS1 Global Traceability Standard, which ensure consistent identification of products, locations, and parties across borders using unique identifiers like Global Trade Item Numbers (GTINs).^[7] These standards facilitate data exchange between trading partners, supporting critical functions like product recalls and inventory optimization.^[1] Track and trace is particularly vital in regulated industries, where it directly supports legal mandates and public safety. In the pharmaceutical sector, for instance, the U.S. Drug Supply Chain Security Act (DSCSA) mandates electronic, interoperable tracing of prescription drugs at the package level to prevent counterfeit or substandard medications from entering the market, requiring trading partners to verify product legitimacy and share transaction data.^[2] Similarly, in food supply chains, traceability systems enable rapid identification and isolation of contaminated items, as emphasized by frameworks like the FDA's Food Safety Modernization Act (FSMA), reducing recall scopes and protecting consumers.^[8] Beyond compliance, the implementation of track and trace yields broader benefits, including improved inventory management, reduced waste through route optimization, enhanced customer trust via provenance verification, and sustainability gains by minimizing ecological impacts from inefficient logistics.^[9]^[10]

Overview

Definition

Track and trace is a systematic process for monitoring the location, status, and historical path of products or assets throughout their entire lifecycle, from origin to final consumption, achieved through the assignment of unique identifiers and the maintenance of detailed data records at each stage.^[7] This approach provides stakeholders with comprehensive visibility into the movement and condition of items, enabling verification of authenticity, compliance, and integrity across supply networks.^[11] At its core, track and trace operates on two fundamental principles: forward tracking and backward tracing. Forward tracking involves actively following the progressive movement of an item as it advances through the supply chain from one party to the next, often in near real-time to support ongoing logistics decisions.^[12] Backward tracing, conversely, reconstructs the item's history by retracing its path from a specific endpoint back to the source, facilitating investigations such as product recalls or quality audits.^[12] Together, these principles ensure end-to-end accountability and rapid response capabilities within complex distribution systems.^[11] The essential components of a track and trace system include unique identification of items, data collection at key points along the chain, and secure storage mechanisms for the information. Unique identifiers, such as serial numbers, are assigned to individual products or batches to distinguish them unambiguously.^[7] Data collection occurs at transfer points, capturing details like timestamps, locations, and handlers, while databases—whether centralized repositories or distributed ledgers—serve as the backbone for querying and sharing this data across authorized parties.^[11] While the terms are often used interchangeably, tracking emphasizes real-time or prospective monitoring of an item's current position and forward trajectory, whereas tracing focuses on retrospective analysis using archived records to map past movements.^[12] This distinction underscores the dual nature of the system, balancing operational efficiency with forensic capabilities.^[7]

Importance

Track and trace systems play a pivotal role in enhancing product safety by enabling precise identification and isolation of contaminated or defective items throughout the supply chain, thereby minimizing risks to consumers and reducing the spread of unsafe products.^[13] These systems significantly improve recall efficiency, allowing companies to pinpoint affected batches in hours rather than weeks, which limits the scope of recalls and protects public health.^[14] Additionally, they ensure compliance with stringent industry regulations, such as those from the FDA and EU authorities, by providing verifiable documentation of product journeys that auditors require.^[15] Fraud prevention is another core benefit, as serialization and unique identifiers detect counterfeits entering legitimate channels, safeguarding brand integrity and preventing illicit trade. Economically, track and trace technologies deliver cost savings through optimized inventory management, where real-time visibility helps balance stock levels and avoid overstocking or shortages.^[16] Reduced waste is achieved by tracking expiration dates and usage patterns, minimizing spoilage in perishable goods sectors like food and pharmaceuticals.^[16] Overall supply chain efficiency improves, with better forecasting and logistics coordination that can cut stockouts substantially, enhancing operational performance and profitability.^[17] Beyond direct operational gains, these systems foster broader impacts such as building consumer trust through transparent provenance that assures product authenticity and quality.^[18] They support sustainability tracking by verifying ethical sourcing, such as confirming conflict-free minerals or fair labor practices, which aligns with global environmental standards.^[19] In global trade, track and trace mitigates risks like supply disruptions or non-compliance penalties by providing end-to-end visibility across borders.^[20] The global track and trace solutions market, driven by escalating regulatory demands, is projected to reach $18.56 billion by 2032.^[21]

History

Early Developments

In the pre-digital era of the early 20th century, track and trace in manufacturing and logistics primarily relied on manual record-keeping and paper-based systems to manage inventory, shipments, and supply flows. These methods involved handwritten ledgers, manifests, and physical documentation to record goods movement, enabling basic accountability in mass production environments like assembly lines.^[22] Such practices were labor-intensive and prone to errors but formed the foundation for coordinating complex supply chains amid growing industrialization.^[23] During World War II, military supply chains exemplified early organized tracking efforts, using manual documentation and logistical manifests to monitor vast quantities of munitions, food, and equipment across global theaters. The U.S. Army Service Forces implemented supply control systems to track stock levels and distributions, ensuring timely delivery to front lines through paper records and centralized planning. These wartime innovations highlighted the critical need for reliable tracing to support operational efficiency under high-stakes conditions.^[24] The shift toward automated identification began with the development of the Universal Product Code (UPC) barcode system in 1974 by IBM engineer George Laurer, who designed a linear symbology to enable machine-readable product labeling for retail scanning. Adopted by the grocery industry, the UPC was first scanned on June 26, 1974, at a Marsh supermarket in Troy, Ohio, on a pack of Wrigley's Juicy Fruit gum, marking a pivotal transition from manual to automated data capture.^[25] This innovation streamlined checkout processes and laid the groundwork for broader traceability in commerce.^[25] By the 1980s, barcodes saw initial adoption in logistics and shipping, with companies like United Parcel Service (UPS) integrating them as precursors to modern parcel tracking systems to automate sorting and routing. The U.S. Department of Defense's LOGMARS program in 1981 further promoted barcode use in military logistics for item identification, influencing civilian applications.^[26] These early implementations improved accuracy in high-volume environments but remained limited compared to later technologies like RFID.^[27] Early motivations for track and trace were intensified by product safety crises, such as the 1982 Tylenol tampering incident in Chicago, where seven people died after consuming cyanide-laced capsules, exposing vulnerabilities in consumer product distribution. Johnson & Johnson recalled over 31 million bottles by lot number, underscoring the need for effective tracing to isolate contaminated batches and prevent widespread harm.^[28] This event prompted the industry to prioritize basic lot-based tracking mechanisms as a foundational step toward enhanced safety protocols.^[28]

Key Milestones

The 1990s e-commerce boom marked a pivotal shift toward consumer-facing track and trace systems, with Amazon launching its online bookstore in July 1995 and introducing early order and package status updates that allowed customers to monitor shipments from purchase to delivery.^[29] This innovation set a precedent for real-time visibility in retail supply chains, contrasting with prior industry reliance on manual or carrier-specific notifications.^[30] A major technological breakthrough occurred in 2004 with the release of the EPCglobal Gen2 protocol by EPCglobal (now part of GS1), which standardized ultra-high frequency (UHF) RFID air interface specifications to enable global interoperability for item-level tracking.^[31] The protocol, ratified on December 16, 2004, addressed limitations of earlier RFID generations by supporting higher read rates and anti-collision features, facilitating widespread adoption in supply chain management.^[32] Turkey initiated development of a national-scale pharmaceutical track and trace system in 2007, with the first phase launching in 2010 and full implementation in 2012. Known as İlaç Takip Sistemi (ITS), it was among the first comprehensive domestic systems to combat counterfeiting and reimbursement fraud through centralized monitoring of drug movements from production to patient dispensing and serving as a model for global implementations.^[33]^[34] Regulatory mandates accelerated adoption in the pharmaceutical sector, with the European Union's Falsified Medicines Directive (2011/62/EU) adopted in 2011 requiring serialization via unique identifiers on prescription medicines to verify authenticity and enable end-to-end tracing.^[35] Similarly, the U.S. Drug Supply Chain Security Act (DSCSA), enacted in 2013 as Title II of the Drug Quality and Security Act, mandated electronic, interoperable tracing of prescription drugs through serialization at the package level to enhance supply chain integrity. Phased implementation occurred over the following decade, with full electronic, interoperable tracing requirements enforced starting in 2023, subject to extensions; as of November 2025, compliance deadlines for trading partners extend through the year, including May 27 for manufacturers and repackagers, August 27 for wholesale distributors, and November 1 for dispensers.^[2] In the 2020s, the COVID-19 pandemic drove integration of Internet of Things (IoT) technologies into track and trace for vaccine distribution, enabling real-time monitoring of temperature, location, and handling conditions to ensure cold chain compliance during global rollouts.^[36] For instance, IoT sensors were deployed in logistics networks to track vaccine shipments, preventing spoilage and supporting equitable distribution amid unprecedented demand.^[37] GS1 standards, including the EPC and Global Traceability Standard, underpinned many of these milestones by providing foundational identification and data-sharing protocols.^[7]

Technologies

Identification Methods

Identification methods in track and trace systems rely on assigning unique identifiers to products, items, or assets, which are then read using various technologies to enable monitoring throughout the supply chain. These methods ensure each entity has a distinct, verifiable identity, facilitating accurate tracking from production to delivery.^[7] Serial number assignment forms the foundation of unique product-level identification, where a serial number is combined with a Global Trade Item Number (GTIN) to create a globally unique identifier for each individual item. Under GS1 standards, this combination—known as a Serialized Global Trade Item Number (SGTIN)—ensures no reuse of serial numbers for the same GTIN, providing unambiguous traceability without conflicts across global systems. This approach supports item-level tracking by linking the identifier to supply chain events, such as manufacturing and distribution.^[7]^[38] Barcode systems encode these unique identifiers for optical scanning, with linear (1D) barcodes and two-dimensional (2D) barcodes serving as primary carriers. 1D barcodes, such as UPC or GS1-128, consist of vertical lines and spaces that encode limited data, typically 12 to 48 characters, making them simple and cost-effective for printing on packaging and suitable for basic product identification in retail and logistics. Their advantages include low production costs and ease of implementation with standard linear scanners, though they require line-of-sight reading.^[39]^[40] In contrast, 2D barcodes like QR codes or GS1 DataMatrix use matrix patterns of squares or dots to store significantly more data—up to thousands of characters—enabling inclusion of serial numbers, batch details, and expiration dates in a single scan. These are scanned via image-based readers and offer greater density for complex track and trace needs, such as in pharmaceuticals, despite slightly higher complexity in design.^[39]^[41] Radio Frequency Identification (RFID) tags provide contactless reading of unique identifiers, with passive and active variants differing in power source and range. Passive RFID tags, powered by the reader's electromagnetic field, are cost-effective and widely used for item-level tracking; the EPCglobal Gen2 standard governs UHF passive tags in the 860-930 MHz range, defining protocols for encoding GS1 identifiers like SGTINs to support high-volume supply chain reads. Typical read distances for passive Gen2 tags reach up to 10-12 meters, ideal for warehouse inventory without batteries.^[31]^[42] Active RFID tags, equipped with batteries, actively transmit signals for longer ranges—up to 100 meters or more—enabling real-time tracking of high-value assets like pallets in large facilities, though at higher cost due to the power source. The Gen2 protocol enhances security and reduces interference for reliable identification in dynamic environments.^[31]^[42] Near-field communication (NFC) extends RFID principles for short-range, mobile-friendly identification, where NFC tags store unique identifiers readable by smartphones or dedicated readers within 4-10 centimeters. These passive tags integrate seamlessly into packaging for consumer-level scanning, enhancing track and trace by allowing verification of authenticity and location history without specialized equipment. NFC's simplicity supports widespread adoption in supply chains for anti-counterfeiting and asset monitoring.^[43]^[44] Blockchain-based identifiers leverage distributed ledger technology to create tamper-proof serialization, where unique serial numbers are recorded immutably across a network of participants. In pharmaceutical applications, blockchain systems like those piloted under FDA's DSCSA use GS1 standards to link serialized data (e.g., GTIN and serial number) in an unalterable chain, preventing duplication or alteration and ensuring verifiable provenance from manufacturer to dispenser. This method provides cryptographic security for high-stakes track and trace, reducing risks of fraud through consensus-verified transactions.^[45]^[45]

Data Capture and Storage

Data capture in track and trace systems primarily relies on scanners, sensors, and Internet of Things (IoT) devices to collect real-time information at key checkpoints such as manufacturing lines and warehouses. Barcode scanners and RFID readers enable automated entry of identification data by reading labels or tags as items pass through conveyor systems or loading docks, ensuring accurate recording without manual intervention.^[46] IoT sensors, including those for environmental monitoring, further augment this process by capturing dynamic attributes like temperature or humidity alongside positional data during transit.^[47] Storage of captured data occurs through centralized databases or cloud-based platforms, each offering distinct advantages for scalability and accessibility in traceability applications. Centralized databases provide controlled, on-premises management suitable for organizations with high security needs and legacy systems, allowing efficient querying of historical events within a single repository.^[48] In contrast, cloud-based platforms facilitate distributed access and real-time synchronization across global supply chains, reducing latency and enabling seamless scaling for high-volume data flows.^[49] A key standard in this domain is EPCIS (Electronic Product Code Information Services), developed by GS1, which standardizes event capture and storage to support interoperability by structuring data as timestamped records of product movements and states.^[50] Core data elements in these systems include location, timestamp, batch number, and details of transformation events such as aggregation (combining items into larger units) or disaggregation (breaking down units). Location data, often derived from GPS or facility identifiers, pinpoints an item's position at the time of an event, while timestamps ensure chronological accuracy for auditing purposes. Batch numbers link multiple items produced under the same conditions, facilitating recall or quality control, and transformation events capture changes in hierarchy, such as packing cases into pallets. These elements, defined in the GS1 Core Business Vocabulary (CBV), form the foundation for event repositories in EPCIS-compliant systems.^[50]^[51] Integration of capture and storage components is achieved via APIs and middleware to connect disparate systems and ensure data interoperability across supply chains. RESTful APIs, as specified in EPCIS 2.0, allow for standardized querying and capture of events between trading partners, enabling automated data exchange without custom coding. Middleware solutions act as intermediaries, translating formats and handling protocols to bridge legacy enterprise resource planning (ERP) systems with modern cloud repositories, thus maintaining data flow integrity.^[50]^[52]

Applications

Supply Chain Management

Track and trace systems play a pivotal role in supply chain management by providing end-to-end visibility of goods movement, enabling logistics professionals to monitor shipments in real time across warehouses, transportation, and distribution centers. This capability allows companies to identify bottlenecks, predict delays, and coordinate resources more effectively, ultimately streamlining operations in sectors like retail and manufacturing. For instance, technologies such as RFID and barcodes facilitate automated data capture at key points, enhancing accuracy without delving into specific identification methods.^[53]^[54] In inventory tracking, track and trace offers real-time visibility that optimizes stock levels and reduces losses by alerting managers to discrepancies between expected and actual inventory. In retail, this leads to fewer stockouts and overstock situations, improving order fulfillment speeds and customer satisfaction while minimizing carrying costs. Manufacturing firms benefit similarly through better demand forecasting and waste reduction, as systems track components from raw materials to finished products, preventing excess inventory buildup. For example, real-time data integration allows for just-in-time replenishment, reducing storage needs in some operations.^[55]^[56]^[16] Reverse logistics leverages track and trace to manage product returns, repairs, and recalls efficiently, ensuring items are routed back through the supply chain with minimal disruption. In the automotive sector, this is critical for tracing spare parts during recalls, where systems identify affected components across global networks, enabling swift retrieval and replacement to avoid safety risks and financial losses. Such tracing supports refurbishment and resale of returned parts, closing the loop on sustainability while reducing disposal costs. Automotive manufacturers, for instance, use serialized tracking to verify part authenticity during reverse flows, streamlining compliance with warranty claims.^[57]^[58]^[59] For global trade, track and trace enhances customs compliance by providing verifiable documentation of goods' origins and paths, accelerating border clearances and reducing paperwork delays in international shipping. It combats anti-counterfeiting by authenticating products at ports, preventing illicit goods from entering legitimate channels and protecting brand integrity. Governments and businesses collaborate on secure tracing protocols to monitor high-risk cargo, ensuring transparency that mitigates fraud in cross-border transactions. This has proven effective in sectors reliant on imported components, where traceability verifies compliance with trade agreements.^[60]^[61]^[62] A notable case study is Walmart's RFID mandate in the mid-2000s, which required its top suppliers to tag pallets and cases for improved supply chain efficiency. Announced in 2003, the initiative aimed to enhance inventory accuracy and reduce out-of-stocks, leading to a reported 16% improvement in on-shelf availability within the first year of implementation. By 2005, Walmart expanded the program, resulting in labor cost savings and faster replenishment cycles, demonstrating how mandated track and trace can drive systemic efficiencies across a retail giant's network. The mandate significantly reduced phantom inventory in participating distribution centers, with reports of up to 70% improvement in inventory accuracy.^[63]^[64]^[65]

Pharmaceutical Industry

In the pharmaceutical industry, track and trace systems are essential for ensuring drug authenticity, preventing counterfeiting, and maintaining product integrity throughout the supply chain. Serialization, a core component, involves assigning unique identifiers—such as serialized numbers encoded in 2D barcodes—to individual drug packages, enabling verification at each stage from manufacturing to dispensing. This approach combats the global issue of falsified medicines, which the World Health Organization estimates affect up to 10% of drugs in low- and middle-income countries, though rates are lower in regulated markets. The U.S. Drug Supply Chain Security Act (DSCSA), enacted in 2013, mandates electronic, interoperable tracing of prescription drugs at the package level to build an electronic, interoperable system for identifying and tracing products, with staggered full implementation deadlines in 2025 to enhance supply chain security and facilitate rapid removal of potentially harmful drugs. Similarly, the European Union's Falsified Medicines Directive (FMD), implemented via Directive 2011/62/EU and effective from February 2019, requires safety features including unique identifiers and anti-tampering devices on prescription medicine packaging, integrated into a centralized verification system to authenticate products and protect public health. These regulations drive the adoption of technologies like GS1 standards for data exchange, ensuring seamless interoperability across borders.^[2]^[35] Cold chain monitoring represents another critical application, particularly for temperature-sensitive products like vaccines and biologics, where deviations can render them ineffective or unsafe. Sensors integrated into track and trace systems, such as RAIN RFID, Bluetooth Low Energy (BLE), and GPS-enabled devices, provide real-time data on temperature, humidity, and location, adhering to standards like GS1 EPCIS 2.0 for event capture and sharing. For instance, these technologies enable automated alerts for excursions beyond specified ranges (e.g., 2–8°C for most vaccines), reducing spoilage risks and ensuring compliance with guidelines from bodies like the CDC and WHO.^[66] Track and trace facilitates efficient recall processes by allowing precise identification and isolation of affected batches, minimizing health risks from contaminated or defective products. The 2008 heparin contamination crisis, involving oversulfated chondroitin sulfate that led to nearly 100 deaths worldwide, underscored traceability gaps in global supply chains, particularly in raw material sourcing from unregulated facilities; lessons from this event emphasize the need for end-to-end serialization, stricter cGMP oversight, and advanced detection assays to enable faster recalls.^[67] Integration with enterprise resource planning (ERP) systems enhances end-to-end visibility, linking serialization data from production lines to distribution and pharmacy levels. Solutions like SAP Advanced Track and Trace for Pharmaceuticals connect with SAP S/4HANA ERP to manage serial numbers, aggregate packaging hierarchies, and generate regulatory reports, ensuring real-time tracking of individual units while supporting compliance with DSCSA and FMD requirements. This integration streamlines operations, reduces manual errors, and provides a centralized repository for transaction events, ultimately safeguarding patient safety.^[68]

Food and Beverage

In the food and beverage industry, track and trace systems are essential for safeguarding public health by enabling rapid identification and response to contamination risks throughout the supply chain. These technologies facilitate the monitoring of products from raw materials to consumer shelves, minimizing the spread of foodborne illnesses and ensuring compliance with safety standards. By integrating unique identifiers and digital records, companies can pinpoint issues such as adulteration or spoilage, reducing economic losses from recalls and enhancing consumer trust.^[69] Source-to-shelf tracing plays a critical role in preventing contamination by allowing stakeholders to track ingredients and products across multiple stages, from sourcing to retail distribution. For instance, during the 2018 multistate E. coli O157:H7 outbreaks linked to romaine lettuce from the Yuma, Arizona growing region, traceback investigations by the FDA and CDC identified irrigation canal water contaminated by nearby cattle operations as the likely source, affecting over 200 people and leading to widespread recalls. This event underscored the limitations of manual tracing, prompting accelerated adoption of digital tools like blockchain to achieve end-to-end visibility within hours rather than days. Walmart, in response, mandated blockchain-based tracing for leafy greens suppliers, enabling farm-to-store tracking in seconds and preventing future delays in outbreak responses.^[70]^[71]^[72]^[73] Farm-to-fork systems leverage blockchain to verify organic certifications and substantiate sustainability claims, providing immutable records of production practices from cultivation to consumption. Pilots in Europe and the US have demonstrated how distributed ledger technology records data on soil quality, pesticide use, and harvest details, allowing consumers to scan QR codes for provenance verification. A study on organic food chains found that blockchain integration boosts consumer trust by 25-30% through transparent auditing, reducing fraud in premium markets like fair-trade coffee and certified produce. These systems also support regulatory audits by maintaining tamper-proof logs, as seen in IBM Food Trust implementations for brands like Nestlé, which trace cocoa and dairy origins to combat deforestation claims.^[74]^[75]^[76] For perishables, track and trace enables precise expiry date monitoring to curb waste in grocery supply chains, where up to 40% of food loss occurs due to spoilage. RFID and IoT sensors integrated into inventory systems allow real-time temperature and humidity tracking during transport and storage, alerting managers to deviations that accelerate deterioration. In wholesale markets, such technologies have reduced perishable waste by 15-20% through automated first-expired-first-out protocols, as evidenced by dynamic shelf-life models that predict usability based on environmental data. Grocery chains like Tesco have adopted app-based analytics to optimize stock rotation, diverting near-expiry items to donation programs and cutting annual losses by millions of tons globally.^[77]^[78]^[79] Compliance with the US Food Safety Modernization Act (FSMA) of 2011 further drives these practices, as Section 204 mandates detailed traceability records for high-risk foods like leafy greens, sprouts, and shell eggs to facilitate swift recalls. The FDA's 2022 final rule under FSMA requires entities to maintain key data elements, such as lot codes and transformation records, enabling one-step-forward and one-step-back tracing within 24 hours of an outbreak alert, with compliance originally set for 2026 but proposed for extension to 2028 as of 2025. This is expected to improve recall efficiency and help prevent foodborne illnesses, including the estimated 1.35 million annual Salmonella cases reported by the CDC. International suppliers must align with these standards for US market access, promoting global harmonization in food safety protocols.^[69]^[80]^[81]

Standards and Regulations

Global Standards

Global standards for track and trace systems are established by international organizations to ensure consistency, interoperability, and efficiency in supply chain visibility worldwide. These frameworks provide foundational guidelines for identification, data capture, and sharing, enabling organizations to implement traceable processes that transcend national boundaries. Key bodies such as GS1 and the International Organization for Standardization (ISO) develop these standards, focusing on universal principles rather than sector-specific applications. The GS1 System offers a comprehensive suite of global standards for product identification using barcodes, radio-frequency identification (RFID) tags, and associated data-sharing mechanisms. These standards facilitate unique identification of items, locations, and parties through keys like the Global Trade Item Number (GTIN) and Global Location Number (GLN), supporting end-to-end traceability in diverse industries. Central to this is the GS1 Global Traceability Standard, first published in 2006, which defines minimum requirements for designing and implementing traceability systems, including core business processes for capturing and exchanging traceability data independent of specific technologies.^[82] EPCglobal, originally an independent standards organization and now fully integrated under GS1, develops protocols for RFID applications in supply chains. Its flagship EPC Radio-Frequency Identity Protocols Class-1 Generation-2 UHF RFID standard, ratified in 2004 and adopted as ISO 18000-6C in 2006, specifies the air interface for encoding and reading Electronic Product Code (EPC) data, enabling real-time capture of supply chain events such as movements and transactions. This protocol supports dense-reader environments and ensures compatibility across global RFID deployments.^[83] ISO contributes sector-focused standards that align with broader track and trace goals. ISO 22005:2007 outlines general principles and basic requirements for designing and implementing traceability systems in the feed and food chain, applicable to any organization at any step, to determine product history or location for safety and quality objectives.^[84] For the automotive sector, ISO 28219:2017 provides guidelines for labelling and direct product marking using linear bar codes and two-dimensional symbols, ensuring machine-readable serialization of components to automate processes like inventory control and quality assurance.^[85] Collectively, these standards emphasize interoperability to enable seamless cross-border data exchange, allowing trading partners to share traceability information without proprietary barriers and promoting scalable, cost-effective solutions across global supply chains. For example, in the pharmaceutical industry, GS1 standards support serialization for counterfeit prevention, as detailed in sector-specific applications.^[86]

Regional Regulations

In the United States, the Drug Supply Chain Security Act (DSCSA), enacted in 2013 as Title II of the Drug Quality and Security Act, mandates the serialization of prescription drugs to enable electronic tracking and tracing throughout the supply chain. Enforcement of interoperability requirements is phased as of 2025: manufacturers and repackagers by May 27, 2025; wholesale distributors by August 27, 2025; and dispensers with 26 or more full-time employees by November 27, 2025, with smaller dispensers receiving a further two-year extension.^[2] This legislation requires manufacturers, repackagers, wholesale distributors, and dispensers to capture and share standardized product identifiers, including lot numbers and expiration dates, to combat counterfeit drugs and ensure patient safety.^[87] The European Union addressed falsified medicines through Directive 2011/62/EU, known as the Falsified Medicines Directive (FMD), which introduced mandatory safety features on medicinal products, including a unique identifier for serialization and an anti-tampering device.^[35] These requirements, aimed at verifying authenticity and preventing counterfeits from entering the legal supply chain, became applicable across EU member states on February 9, 2019, with national repositories established to facilitate verification.^[88] Turkey pioneered a nationwide pharmaceutical track-and-trace system in 2006, known as the İlaç Takip Sistemi (ITS), which serializes all medicines at the unit level using GS1 standards to monitor the supply chain from manufacturer to patient.^[89] This end-to-end system has served as a model for emerging markets by reducing reimbursement fraud, enabling rapid recalls, and enhancing supply chain transparency, with over 99% compliance achieved within its first few years.^[33] In China, the State Council's 2016 Opinions on Accelerating the Construction of Traceability Systems for Key Products established rules for drug traceability, requiring pharmaceutical enterprises to implement coding and information-sharing mechanisms to track drugs from production to distribution.^[90] In 2025, comprehensive promotion of drug traceability codes was initiated, with hospitals required to scan codes for reimbursement starting July 2025 to strengthen safety and prevent fraud.^[91] India's Drugs Rules, amended in 2022 via Gazette Notification G.S.R. 823(E), mandate the use of QR codes on active pharmaceutical ingredients (APIs) manufactured or imported for export, including details such as batch number, manufacturing date, and expiry to facilitate international traceability.^[92] This requirement, effective from January 1, 2023, supports global compliance and export verification, particularly for bulk drugs destined for regulated markets.^[93] In October 2025, the government mandated QR code-based traceability for vaccines and anticancer medicines to enhance monitoring and public safety.^[94]

Challenges

Implementation Barriers

Implementing track and trace systems in supply chains often encounters significant cost barriers, primarily due to high initial investments in hardware, software, and personnel training. For instance, passive RFID tags, a common component for item-level tracking, cost between $0.10 and $1.50 each, but when scaled to millions of units in large operations, these expenses can escalate dramatically, alongside reader hardware at around $3,000 per unit and software integration that may run into hundreds of thousands of dollars annually for enterprise systems.^[95] Additionally, training staff to operate these technologies adds to the financial burden, with specialized programs and change management efforts required to ensure effective deployment, particularly straining resources for smaller operations.^[96] Interoperability issues further complicate deployment, as legacy systems and incompatible platforms across supply chain partners create data silos and hinder seamless information exchange. In many cases, older infrastructure, such as custom ERP systems running on outdated software like Windows 95, resists integration with modern track and trace tools, while the absence of universal data standards—such as varying electronic data interchange (EDI) formats—prevents syntactic and semantic alignment.^[97] These challenges are exacerbated in multi-tier supply chains, where 56% of executives report interoperability as a primary obstacle, often necessitating costly middleware or enterprise service buses to bridge disparate systems like CRM, ERP, and manufacturing execution software.^[98] Scalability poses operational hurdles, especially in global supply chains handling high volumes of real-time data from IoT sensors, barcode scanners, and RFID readers, which can overwhelm existing logistics infrastructure during peak periods. Managing heterogeneous data types and ensuring robust processing for complex correlations between goods and materials requires advanced solutions like data lakes or NoSQL databases, yet many organizations struggle with the volume and velocity of information generated.^[98] This limitation in real-time processing can lead to delays in tracking across international networks, amplifying inefficiencies as chains expand. Recent regulatory deadlines, such as the full enforcement of the U.S. Drug Supply Chain Security Act (DSCSA) for larger dispensers by November 27, 2025, further heighten these barriers by requiring rapid system upgrades and compliance verification across global partners.^[2] Adoption resistance, particularly among small and medium-sized enterprises (SMEs), stems from perceptions of unaffordability, lack of expertise, and time pressures that prioritize immediate productivity over long-term technological upgrades. SMEs often view track and trace as an expense rather than an investment, lacking the skilled personnel to implement and maintain systems, which leads to hesitation in buy-in from supply chain partners. Cultural barriers and the need for extensive training further impede collaboration, as partners resist sharing data due to competitive concerns or resource constraints, slowing overall network-wide adoption.^[96]

Privacy and Security

Track and trace systems in supply chains collect vast amounts of data on product movements, origins, and transactions, which can expose sensitive information such as proprietary manufacturing processes or vendor relationships, potentially leading to competitive disadvantages if accessed by rivals.^[99] Data breaches in these systems have resulted in the theft of intellectual property and confidential business details, amplifying risks for organizations reliant on real-time visibility.^[100] In the pharmaceutical sector, traceability systems handle sensitive supply chain and transaction data, and unauthorized exposure can lead to regulatory penalties under frameworks like the EU's General Data Protection Regulation (GDPR).^[101] Security threats to track and trace infrastructure, particularly RFID-based systems, include hacking attempts that enable counterfeit data injection through tag cloning or spoofing, allowing malicious actors to insert false provenance records and disrupt authenticity verification.^[102] Eavesdropping on unencrypted RFID communications poses another risk, where attackers intercept signals to track high-value shipments or alter logistics data mid-transit.^[103] A notable example is the 2019 ShadowHammer attack on ASUS software updates, which compromised supply chain integrity by injecting malware into legitimate distribution channels, affecting thousands of devices and highlighting vulnerabilities in digital traceability tools.^[104] To counter these threats, encryption protocols such as AES-128 for RFID tag data protect against interception by scrambling transmissions during inventory scans and updates.^[105] Anonymization techniques, including pseudonymization of identifiers in traceability logs, further mitigate re-identification risks by replacing unique serial numbers with temporary hashes while preserving analytical utility for audits.^[106] Compliance with GDPR is essential for systems handling personal data in tracing, requiring data minimization—collecting only necessary details—and explicit consent for processing consumer-linked information, with non-compliance risking fines up to 4% of global annual turnover.^[107] In pharmaceutical applications, attribute-based encryption ensures that only authorized parties access serialized drug tracking data, aligning with GDPR's privacy-by-design principles.^[108] Ethical concerns arise in balancing comprehensive traceability with consumer privacy, particularly in food and pharmaceutical supply chains where end-to-end tracking can inadvertently reveal personal purchasing habits or health profiles.^[109] In the food industry, regulations like GDPR prohibit non-consensual monitoring of consumer transactions, forcing companies to anonymize point-of-sale data to avoid profiling while maintaining recall capabilities for contamination events.^[110] For pharmaceuticals, ethical traceability must weigh public health benefits—such as combating counterfeits—against individual rights, with frameworks emphasizing informed consent and data protection impact assessments to prevent misuse of serialized medicine records.^[111] These tensions underscore the need for governance models that integrate privacy protections without undermining the transparency essential for safety and accountability.^[112]

Future Trends

Emerging Technologies

Emerging technologies are revolutionizing track and trace systems by enhancing data integrity, predictive capabilities, and real-time monitoring across supply chains. These innovations address limitations in traditional methods, such as vulnerability to tampering and delays in data processing, enabling more robust and efficient traceability from production to delivery. Blockchain, artificial intelligence (AI), advanced Internet of Things (IoT) sensors, and 5G connectivity represent key advancements that promise greater transparency and responsiveness in diverse industries.^[113]^[114] Blockchain integration provides decentralized ledgers that create immutable records of product journeys, preventing alterations and ensuring verifiable provenance. This technology distributes data across a network of nodes, where each transaction is cryptographically secured and consensus-verified, making it ideal for high-stakes track and trace applications like food safety and pharmaceuticals. A prominent example is IBM Food Trust, launched commercially in 2018, which leverages Hyperledger Fabric to connect growers, processors, distributors, and retailers, allowing traceability of items like leafy greens in seconds rather than days.^[113]^[115]^[116] AI and machine learning enable predictive analytics for anomaly detection, analyzing vast datasets from supply chain sensors to identify irregularities such as delays, counterfeit intrusions, or quality deviations before they escalate. Machine learning algorithms, including supervised models like random forests and unsupervised ones like autoencoders, process historical and real-time data to forecast disruptions and optimize routing, reducing risks in global logistics. In supply chain security, AI platforms monitor supplier performance, shipping metrics, and inventory flows, flagging outliers that could indicate fraud or spoilage with high accuracy.^[117]^[114]^[118] Advanced IoT involves sensor networks that provide continuous environmental monitoring, particularly for sensitive goods like pharmaceuticals where conditions such as temperature and humidity must remain stable to preserve efficacy. These networks deploy low-power, wireless sensors integrated with edge computing to transmit data in real time, alerting stakeholders to excursions that could compromise product integrity during storage or transit. In pharmaceutical cold chains, IoT solutions track humidity levels alongside temperature, ensuring compliance with standards like Good Distribution Practices and minimizing waste from spoiled batches.^[119]^[120]^[121] 5G-enabled real-time tracking reduces latency in global logistics by supporting ultra-reliable, low-delay communications that facilitate instantaneous data exchange between devices and central systems. With latency as low as one millisecond, 5G allows for seamless integration with IoT and AI, enabling dynamic adjustments like rerouting shipments based on live traffic or weather data. This connectivity enhances visibility in complex supply chains, where millions of connected assets—such as trucks and containers—can be monitored without bottlenecks, improving overall efficiency and response times.^[122]^[123]^[124]

Market Developments

The track and trace solutions market is projected to expand from USD 6.96 billion in 2025 to USD 12.27 billion by 2030, achieving a compound annual growth rate (CAGR) of 12.0%. This growth is primarily propelled by the pharmaceutical sector's need for stringent regulatory compliance, such as the U.S. Drug Supply Chain Security Act (DSCSA), and the food and beverage industry's demand for enhanced supply chain transparency to combat counterfeiting and ensure product authenticity.^[125] Industry developments in track and trace are shifting from logistics-centric systems to deeply integrated manufacturing processes aligned with Industry 4.0 principles, where digital technologies enable automated traceability throughout production for improved quality control and efficiency. This evolution supports mass customization and real-time process monitoring, reducing downtime and facilitating smaller batch sizes in regulated sectors like pharmaceuticals. Concurrently, cloud-based solutions are gaining prominence, offering scalable deployment, reduced infrastructure costs, and seamless real-time data access across global supply chains.^[126]^[125] Since 2020, adoption trends have intensified around sustainability tracking, with track and trace systems increasingly incorporated into environmental, social, and governance (ESG) reporting frameworks to address regulatory mandates like the European Union's Deforestation Regulation (EUDR) and Corporate Sustainability Reporting Directive (CSRD). These integrations enable batch-level visibility into factors such as land use, emissions, and ethical sourcing, particularly in agri-food supply chains, helping organizations demonstrate compliance and mitigate Scope 3 risks.^[127] Leading companies driving these integrations include TraceLink Inc., which specializes in digital supply network platforms for pharmaceutical compliance, and SAP SE, offering enterprise resource planning solutions with embedded track and trace capabilities for end-to-end visibility. These players facilitate interoperability across ecosystems, supporting regulatory adherence and operational resilience in high-stakes industries.^[128]

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