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Track & Trace

Pharmaceutical serialization and supply chain traceability with GS1 standards, regulatory reporting, and multi-level aggregation.

Solution by Verifarma
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Overview

Verifarma Track & Trace is a pharmaceutical traceability and serialization platform designed for life sciences organizations across the supply chain, including pharmaceutical laboratories, distributors, pharmacies, health institutions, veterinary industry participants, and agrochemical manufacturers. The platform manages serialization, logistical events, regulatory reporting, and dispensing from origin to point of sale, supporting compliance with GS1 standards and the regulatory requirements of multiple markets in Latin America, Europe, and beyond.

Built on a flexible architecture with over 16 years of experience in the sector, Verifarma T&T connects with ERP, WMS, LIMS, production line equipment, and regulatory authorities via open APIs. The platform is validated under GAMP 5, certified under ISO 9001 and ISO 27001, and operates in accordance with GMP and GS1 global identification standards.

Core Platform Capabilities

  • Serialization and multi-level aggregation at L3, L4, and L5 packaging levels.
  • High-speed GS1 serial generation with automatic capture and multi-level aggregation.
  • Management of GS1 codes and regulatory serialization schemes.
  • Serial assignment and batch-to-line allocation, including serialization discard management.
  • Serial exchange with Marketing Authorization Holders (MAH) and Contract Manufacturing Organizations (CMO), including international integrations.
  • Logistical event management: receptions, transfers, shipments, and reconciliation with disaggregation and reaggregation.
  • Management of electronic and physical delivery notes.
  • Connection with ERP, WMS, LIMS, and production systems via open APIs.
  • Integration with health authorities, regulatory hubs, and other L4 systems.
  • Stock and serial dashboard for real-time visibility.
  • Regulatory reports and full traceability records for inspections and audits.
  • Audit trail functionality.

Industry-Specific Solutions

  • Pharmaceutical Laboratories (Verifarma T&T for Laboratories): Manages serialization and event reporting from the production line, with integration to production equipment, ERP, and regulatory systems. Supports serial management and aggregation by packaging level, automatic event submission to authorities, and reports for audits and inspections.
  • Distributors and Wholesalers (Verifarma T&T for Distribution): End-to-end control from goods receipt to dispatch, covering serial reception and validation, electronic and physical delivery note management, inter-warehouse transfers, and immediate recall tools.
  • Pharmacy Networks (Verifarma Red de Farmacias): Centralizes delivery note management, receptions, and dispensing. Includes automatic reception and validation of delivery notes, traced dispensing records, branch-level stock visibility, integration with wholesaler systems, and real-time activity visibility at the pharmacy.
  • Medical Devices: Supports unique device identification (UDI) management, multiple identification technologies, compliance with standards and certifications, ERP integration, and scalability across the supply chain.
  • Veterinary Industry (T&T Verivet): Traceability adapted to veterinary regulations, covering batch and/or serial management, movement and sales tracking, regulatory reports and audits, and visibility across the distributor network.
  • Health Institutions (Verifarma T&T for Institutions): Tracks medications administered or dispensed within institutions, including internal stock and movement control, administration records per regulation, patient safety and regulatory reporting, dose-level fractionation, and reimbursement management.
  • Agrochemical Container and Bulk Management (Veriquim Envases): Full lifecycle traceability of containers under environmental regulations, including compliance with environmental and regulatory requirements, centralized movement control and audit, and blockchain transaction signing.
  • Agrochemical Product Manufacturers and Distributors (Veriquim Producto): Traceability system for phytosanitary products covering unique identification, batch tracking, and regulatory reporting for compliance and health safety.
  • Pharmaceutical Audit and Control (Verifarma Auditor): Centralizes dispensing information from pharmacies and wholesalers, validates against ANMAT regulatory databases and SSS beneficiary records, integrates with ERP, generates reports for SUR submission, and raises alerts for traceability irregularities by GTIN and serial number.
  • Chemical Precursors (Verifarma Precursores Químicos): Manages and traces chemical precursors, including logistical operation records, warehouse management, full substance traceability, internal consumption management, and automatic event reporting to RENPRE/SEDRONAR.

Regulatory Compliance and Standards

  • GS1 global identification standards.
  • ISO 9001 quality management certification.
  • ISO 27001 information security certification.
  • Validatable under GAMP 5 guidelines.
  • GMP compliance.
  • Regulatory expertise covering multiple countries in Latin America, Europe, and other markets.

Implementation and Support

  • Implementation timeline of 60 days.
  • Regional support teams accompanying each implementation and ongoing operation.
  • 24/7 technical support for existing Verifarma system users.
  • Scalable and validated infrastructure designed for regulated environments.
  • Guidance resources available for regulatory entities evaluating serialization and traceability law implementation.

Verifarma Track & Trace is available with offices and support in Spain, Argentina, and Mexico, and provides personalized demonstrations tailored to specific process and regulatory requirements.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Regulatory Information Management (RIM)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Agricultural BiotechBiotechMedical DevicesPharma
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxPISO 27001