FAQs

A Track & Trace solution assigns unique identities to products, captures packaging and movement events, and provides traceability across production, warehousing, and distribution—supporting compliance, recalls, and brand protection.

It helps you prevent counterfeit entry, improve recall speed and precision, reduce distribution errors, and meet country-specific serialization and reporting requirements.

Serialization is the process of generating and applying a unique serial number to each saleable unit (and often to secondary/tertiary packs too), so every pack can be uniquely identified and verified.

Aggregation links unit → bundle → shipper → pallet in a parent–child hierarchy. It reduces scanning time during logistics and supports faster, more accurate traceability during audits and recalls.

Yes—Jekson Vision provides Track & Trace software (including REETRAK) and also delivers vision inspection systems designed for packaging line verification and quality control.

Yes. Modern Track & Trace implementations typically cover multiple levels—from line devices and controllers up to enterprise systems and regulatory reporting. (This approach is widely adopted by leading providers.)

Common levels include:

  • Primary packs (where applicable)
  • Secondary packs (cartons)
  • Tertiary packs (shippers/cases)
  • Pallets
    The exact scope depends on your market and regulation.

Most regulated deployments support 2D DataMatrix, QR, and linear codes like GS1-128, plus human-readable text—based on product type and country requirements.

A Track & Trace setup typically includes printing/marking plus vision verification to check readability, correctness, and grading. If a code fails verification, it’s rejected automatically.

The system flags the event in real time, triggers rejection (if configured), and logs exceptions for investigation—so bad packs don’t enter the supply chain.

Yes. Track & Trace platforms commonly integrate with ERP/MES/WMS to exchange master data, production orders, shipments, and reconciliation events—so traceability stays consistent across systems.

Yes. Most plants retrofit Track & Trace by adding printers, cameras, rejection, and line-level controllers—without replacing the entire line.

Not when engineered correctly. Leading solutions emphasize minimizing disruption through optimized line integration, fast changeovers, and operator-friendly workflows.

Jekson Vision focuses strongly on pharmaceuticals and agrochemicals, where compliance and traceability are typically non-negotiable.

L4/L5 typically refers to enterprise + regulatory exchange layers (site-to-site coordination, partner data exchange, reporting). If you ship to regulated markets or manage multiple plants/CMOs, L4/L5 becomes important. Jekson Vision offers L4/L5-oriented capabilities for end-to-end traceability.

Typical data includes:

  • GTIN/product code
  • Serial number
  • Batch/lot
  • Expiry date
  • Packaging events (commissioning/aggregation/rework/decommission)
  • Shipment and dispatch events

It enables targeted recalls (only affected batches/serials), faster root-cause analysis, and proof of what was shipped, where, and when—reducing recall size and cost.

Most pharma-grade deployments include user access controls, audit trails, and controlled workflows for exceptions and rework. Exact validation deliverables depend on your internal QA process and target markets.

A strong Track & Trace partner provides commissioning, training, documentation support, SLA-based service, and change management for regulation updates and line expansions.

ROI usually comes from:

  • fewer rejections/rework due to better verification
  • reduced downtime through stable integration
  • faster audits + fewer compliance risks
  • fewer losses from counterfeits/diversion
  • faster, smaller recalls

A centralized database where all serialized events are recorded and verified.

Serialization is not yet fully mandatory in Bahrain, but the National Health Regulatory Authority (NHRA) requires proper product identification and traceability. Companies are encouraged to adopt serialization to stay future-ready as regulations evolve.

Bahrain currently expects batch-level traceability, including tracking of product movement, distribution records, and recall readiness. However, there is a gradual shift toward unit-level traceability in line with global standards.

Yes, GS1 standards are widely accepted and recommended. Most companies use 2D DataMatrix codes containing GTIN, batch number, and expiry date to ensure compliance and interoperability.

To ensure 100% inspection accuracy, prevent defective products from reaching consumers, and ensure compliance with industry standards

Companies should:

Implement serialization-ready systems
Adopt GS1-compliant coding
Ensure scalable track & trace infrastructure
Integrate vision inspection for quality assurance

This proactive approach ensures smooth compliance when regulations become stricter

Track & trace systems manage data and product identity, while vision inspection ensures accuracy of that data on the packaging. Together, they create a robust system that ensures compliance, quality, and supply chain transparency.

Handling increasing transaction volumes.

Supply chain traceability breaks.

Track & Trace is a system designed to uniquely identify and follow pharmaceutical products through every step of the supply chain — from manufacturing or import to distribution and dispensing — to prevent counterfeit drugs and enhance patient safety.

Yes. Egypt has mandatory regulations requiring pharmaceutical products to be serialized, reported, and electronically tracked in a national system managed by the Egyptian Drug Authority (EDA).

Key regulations include:

  • EDA Decree No. 161 of 2025 — Unified coding and serialization requirements for pharmaceutical products and medical supplies.
  • EDA Decree No. 475 of 2025 — Establishes the Unified National Electronic Track & Trace System for human and biological medicines.
  • Regulatory guides issued by the EDA define implementation details such as technical requirements and reporting standards.

All human pharmaceutical and biological products under EDA jurisdiction — whether locally manufactured or imported — must comply.

Entities involved in the pharmaceutical supply chain — including manufacturers, importers, distributors, warehouses, pharmacies, and logistics/service providers — must connect to the national system and comply with reporting and verification requirements.

  • Serialization: Every saleable unit must carry a unique identifier (e.g., GS1-compliant GTIN + serial number + batch + expiration) in a 2D DataMatrix barcode.
  • Aggregation: Units must be hierarchically linked to cases and pallets.
  • Electronic Reporting: Data on production, packing, shipping, receiving, and dispensing events must be transmitted in real time to the national system (often using EPCIS standards).
  • Verification: Pharmacies and healthcare providers must verify product authenticity before dispensing.

Yes — compliance is phased:

  • 1 February 2026: Mandatory for fully finished imported pharmaceutical products.
  • 1 August 2026: Mandatory for locally produced, packaged, or repackaged products.

Products manufactured or imported after these dates must be registered in the national Track & Trace system before marketing.

Yes — products not properly serialized, registered, or reported may be prohibited from commercial circulation, seized, or subject to regulatory penalties under the EDA’s enforcement powers.

Yes. The system uses international standards (e.g., GS1 DataMatrix barcodes, GTIN, and EPCIS event reporting) to ensure consistency and interoperability.

Pharmacies, hospitals, and other dispensing points must scan the 2D codes to verify authenticity and product status before dispensing. Any product that cannot be verified in the national system is typically not allowed to be dispensed.

Products exported from Egypt still need to meet the importing country’s track & trace requirements. Egypt’s serialization may support compliance if aligned with global standards, but exporters must check destination countries’ laws.

Yes. The regulatory framework emphasizes real-time or near real-time reporting of events across the supply chain to the EDA’s centralized platform.

Yes. The EDA has issued and continues to update an official regulatory Traceability Guide outlining the detailed technical and operational requirements for implementation.

Organizations like GS1 Egypt and other industry groups are conducting training programs for pharmaceutical manufacturers and supply chain partners to prepare for compliance.

Manufacturers upload serialized data to EMVS, and verification happens at dispensing points via national systems.

Under the EU FMD, serialization is the process of assigning a unique code to each medicine pack to create its identity.
Verification is the process of scanning and checking that code against a database to confirm the product is genuine and safe.

The system relies on unit-level verification rather than logistics tracking.

Detecting seal integrity across different packaging materials and designs.

They reduce line efficiency and increase rework costs.

Through EMVS integration ensuring interoperability.

Verify print quality, code grading, and tamper seals.

ISO/IEC 15415 for 2D codes.

Fallback procedures with delayed uploads.

Using configurable serialization software with country-specific rules.

Through standardized APIs connecting Level 4 systems with JFDA databases.

GTIN, serial number, batch, and expiry.

Maintaining print quality at high speeds.

Optional but recommended.

Validation checks at each stage.

Ensure barcode readability and reject faulty packs.

Through re-serialization workflows.

Incorrect or duplicate serial numbers.

Using retrofit solutions.

Upload serialized data to national systems.

It uses cryptographic verification codes (crypto tail) in addition to serialization, making it one of the most complex systems globally.

It includes GTIN + serial + verification key + crypto tail generated by authorized systems.

Dependency on government-issued crypto codes and latency in code provisioning.

Strict parent-child aggregation with mandatory reporting at each packaging level.

Printing and verifying crypto codes at high speeds without errors.

High-resolution cameras validate both DataMatrix and embedded crypto elements.

Offline mode allows temporary operations during connectivity issues but requires later synchronization.

Immediate rejection and compliance violation.

Through structured XML/JSON formats to national servers.

Crypto requirements + strict reporting + high penalties.

It follows a centralized architecture where Level 3 (line), Level 4 (site), and Level 5 (enterprise) systems exchange serialized data with SFDA in near real-time via secure APIs.

It includes GTIN (AI 01), serial number (AI 21), expiry (AI 17), and batch (AI 10), encoded in a 2D format readable at high speeds.

Printer-camera synchronization, latency in data exchange, and rejection handling at high speeds (>300 packs/min).

Yes, aggregation requires parent-child relationships between unit, bundle, case, and pallet using hierarchical data structures.

Through secure protocols (HTTPS/API), checksum validation, and audit trails.

Vision systems verify code presence, readability (ISO grading), and correctness before transmitting data.

Rejected packs must be decommissioned and re-serialized to avoid duplication.

Delayed uploads can lead to compliance risks and shipment holds.

Serialized data enables pinpoint traceability down to the unit level.

Using centralized Level 4 systems with load balancing and queue management.

Track & Trace enables identification, serialization, and monitoring of medicines across manufacturing and distribution to ensure compliance and patient safety in the United Arab Emirates.

It supports anti-counterfeiting, improves supply chain transparency, enhances recall readiness, and ensures regulatory compliance.

Pharmaceutical traceability is guided by national healthcare authorities such as the Ministry of Health and Prevention and other regional regulators.

Serialization assigns a unique identifier to each saleable medicine pack to enable product-level tracking and authentication.

  • GTIN (Global Trade Item Number)
  • Unique serial number
  • Batch/lot number
  • Expiry date
    Encoded in GS1 DataMatrix format.

Aggregation links units to bundles, cases, and pallets through parent–child relationships, improving logistics and traceability.

  • Manufacturers
  • Importers
  • Distributors
  • Contract manufacturers
  • Pharmacies and healthcare providers

EPCIS (Electronic Product Code Information Services) enables standardized sharing of serialized product events across supply chain partners.

GS1 UAE defines barcode structures, GTIN allocation, and data exchange standards for traceability.

Based on ISA-95:

  • Level 1: Devices (printers, cameras, scanners)
  • Level 2: Line controllers
  • Level 3: Site serialization servers
  • Level 4: Enterprise repositories
  • Level 5: Partner data exchange

It allows rapid identification of affected batches, shipment locations, and distribution paths, enabling faster corrective action.

Verification confirms the authenticity of serialized identifiers before distribution or dispensing.

  • Commissioning
  • Aggregation
  • Packing
  • Shipping
  • Receiving
  • Decommissioning

Enterprise serialization systems generate unique serial pools, allocate them to packaging lines, and track usage to prevent duplication.

  • Vision inspection systems
  • Thermal inkjet/laser printing
  • 2D DataMatrix coding
  • Serialization line software
  • Enterprise traceability platforms

A Level-3 system that:

  • Stores serialization data
  • Maintains aggregation hierarchy
  • Handles rework and exceptions
  • Syncs with enterprise repositories

Integration enables shipment tracking, aggregation visibility, compliance reporting, and inventory traceability.

  • GAMP 5
  • Computer System Validation (CSV)
  • IQ/OQ/PQ
  • Electronic records compliance frameworks

  • Secure APIs and encrypted communication
  • Role-based access control
  • Audit trails
  • Data protection policies

A system where manufacturers, distributors, and regulators exchange standardized serialized data for end-to-end product visibility.

  • Duplicate serial detection
  • Reprint and recommission workflows
  • Aggregation break handling
  • Manual verification procedures

  • Code read rate
  • Print quality grade
  • Aggregation accuracy
  • Line efficiency impact
  • Rejection rates

  • Integration with legacy packaging lines
  • Data exchange readiness with partners
  • Regulatory alignment across emirates
  • Master data accuracy

Serialized authentication and verification at each supply chain node ensure only legitimate products reach patients.

  • Implement serialization at packaging lines
  • Deploy aggregation capabilities
  • Establish Level 1–Level 4 architecture
  • Adopt EPCIS data exchange standards
  • Conduct validation and compliance assessments

Track & Trace enables identification, serialization, and monitoring of medicines across the supply chain to ensure safety, authenticity, and compliance in the United States.

It prevents counterfeit drugs, supports faster recalls, improves supply chain visibility, and ensures regulatory compliance.

The Drug Supply Chain Security Act (DSCSA) mandates product serialization, traceability, and interoperable electronic data exchange across trading partners.

Serialization assigns a unique identifier to each saleable pharmaceutical pack for unit-level traceability.

  • GTIN (Global Trade Item Number)
  • Unique serial number
  • Batch/lot number
  • Expiry date
    Encoded in a GS1 DataMatrix barcode.

Aggregation links individual packs to bundles, cases, and pallets, enabling faster logistics and parent–child traceability.

  • Manufacturers
  • CMOs
  • Repackagers
  • Wholesale distributors
  • Dispensers and pharmacies

EPCIS (Electronic Product Code Information Services) is a global standard for sharing serialized product event data across supply chain partners.

The FDA defines compliance frameworks, verification requirements, and timelines for secure pharmaceutical traceability.

Based on ISA-95:

  • Level 1: Devices (printers, scanners, cameras)
  • Level 2: Line controllers
  • Level 3: Site serialization server
  • Level 4: Enterprise repository
  • Level 5: External partner interoperability

It enables precise identification of affected batches and their distribution locations, reducing response time and risk.

Verification confirms that serialized product identifiers are authentic and match manufacturer records before distribution.

  • Commissioning
  • Aggregation
  • Packing
  • Shipping
  • Receiving
  • Decommissioning

Enterprise systems create random or sequential serial pools, allocate them to packaging lines, and track usage to prevent duplication.

  • Vision inspection systems
  • Thermal inkjet / laser printers
  • 2D DataMatrix coding
  • Serialization software
  • Enterprise traceability platforms

A Level-3 system that:

  • Stores serialization data
  • Maintains aggregation hierarchy
  • Manages rework and exceptions
  • Integrates with enterprise systems

Integration enables shipment tracking, inventory visibility, compliance reporting, and warehouse-level aggregation control.

  • GAMP 5
  • 21 CFR Part 11
  • Computer System Validation (CSV)
  • IQ/OQ/PQ protocols

  • Data encryption (in transit & at rest)
  • Secure APIs and AS2 communication
  • Role-based access control
  • Audit trails

A network where manufacturers, distributors, and dispensers exchange standardized EPCIS data for end-to-end product traceability.

Common workflows include:

  • Duplicate serial management
  • Reprinting and recommissioning
  • Aggregation break handling
  • Manual verification processes

  • Read rate and print quality
  • Line throughput impact
  • Aggregation accuracy
  • Rejection rates

GS1 US defines GTIN structure, DataMatrix encoding, EPCIS event models, and partner identification standards.

  • Legacy system integration
  • Data exchange readiness
  • Master data accuracy
  • Multi-partner interoperability

  • Implement serialization at packaging lines
  • Deploy aggregation capabilities
  • Integrate Level 1–Level 4 architecture
  • Establish EPCIS data exchange
  • Conduct system validation and compliance audits

It integrates GS1 serialization with an additional cryptographic security layer.

Digital signature, secure API integration, and certified software.

Dependency on centralized crypto code issuance.

Mandatory at multiple packaging levels.

Local compliance requirements and language-specific documentation.

Ensure readability of both DataMatrix and encrypted elements.

Consumers can scan and verify authenticity.

All transactions must be logged and submitted.

Products may be rejected at distribution points.

Pilot runs and validation before full rollout.

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