Brazil Compliance

Whether you're a global manufacturer or a domestic manufacturer, distributor, or pharmacy, Brazil's track and trace regulations—and the business and technology challenges that go with them—are unfamiliar territory. In addition to reporting core supply chain events to a centralized government system, SNCM (Sistema Nacional de Controle de Medicamentos), success in the Brazil market will rely on an end-to-end exchange between manufacturers and downstream trading partners, known as horizontal integration. TraceLink’s network-tenant architecture is designed to meet these unique supply chain network challenges that Brazil will create.

With Brazil’s compressed implementation timeline, companies need a global partner with extensive experience and expertise in solving complex compliance challenges around the world. As your Brazil compliance partner, TraceLink offers local resources with local language skills to provide market expertise as well as project and technical guidance. TraceLink has been a leader in Brazil compliance since 2013, working closely with associations such as Interfarma and Sindusfarma and co-chairing the GS1 Brazil Working Group to help shape the country’s traceability and serialization guidelines.

Unlike solutions that are limited to generating reports, TraceLink’s solution offers comprehensive compliance support and serialization capabilities that help companies orchestrate their business processes from manufacturing to dispensing — including integration with CMOs, 3PLs, wholesalers, and dispensers.

Applications

Product Serialization

A complete suite of proven applications allows companies to create and exchange serial numbers as well as manage serialized operations: Serial Number Manager, Serial Number Exchange, and Serialized Operations Manager.

Brazil Compliance

The Brazil Compliance application is designed to help you meet ANVISA reporting requirements. The application will use TraceLink’s existing capability including trade partner onboarding and data exchange, managing serial number events, and reporting events to the regulatory authority.

Trade Partner Exchange

Trade Partner Exchange is designed to help you meet Brazil’s horizontal integration requirements. The solution will eliminate the labor-intensive and costly need for point-to-point connections by taking advantage of TraceLink’s unique network architecture that allows you to Integrate Once, Interoperate with Everyone™.

Smart Inventory Tracker

Serialization and aggregation management for warehouses and distribution centers, including serialized shipping and receiving and exception management as well as integration with Serialized Operations Manager to trigger associated warehouse events.

Automated Validation Manager

Automated execution of test scripts and documentation to support continual software compliance aligned with GxP standards, including validation materials for Brazil solution components, Smart Inventory Tracker and Product Serialization. Automated Validation Manager addresses the requirements of the Performance Qualification (PQ). With Installation Qualification (IQ) and Operational Qualification (OQ) support also included in the SaaS license, TraceLink reduces the cost and time associated with validating your compliance solution.

TraceLink University

Give your team the training and skills to support your compliance and business requirements. Enhance the value of your TraceLink solutions with instructor-led courses, self-paced learning, and hands-on experiences that go beyond core product training. Select the support that aligns to the needs of each team member—from individual contributors and department managers to administrators.

Read the Solution Brief

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Related Resources

Horizontal Integration: Why It’s Essential for Brazil Compliance

Learn why success in Brazil requires end-to-end data exchange with your downstream trading partners.

2-Minute Video: What You Need to Know About Brazil Compliance

Hear TraceLink experts explain why Brazil may be your biggest compliance challenge.

Brazil Compliance: A Step-by-Step Approach to Serialization

Download this infographic to understand the questions you need to ask as you begin your Brazil serialization journey.

Brazil Compliance: Why Horizontal Integration is Essential for Success

Learn how TraceLink simplifies your biggest challenge: connecting with your Brazil trade partners.

Creating A Single Source of Truth for Your Global Inventory

Learn how TraceLink’s integrated platform can give you visibility into your inventory across your global markets.

Serialization: The Power to Transform Your Business

Watch this 2-minute animation to understand the basics of serialization and how it will affect your business.