Description
TraceLink’s Brazil Compliance application is being designed to enable multinational and Brazilian domestic pharmaceutical manufacturers, or organizations such as agents or 3PLs that support them in managing compliance data and related reporting requirements, to meet upcoming Brazilian regulation and ANVISA requirements for product serialization and compliance reporting to the centralized SNCM (Systema Nacional de Controle de Medicamentos) system.
Benefits
Brazil Compliance will help enable the critical data management and operational process needs of MAHs/pharmaceutical manufacturers, agents of MAHs, 3PLs, wholesale distributors, and other entities with who have business and compliance demands as Brazil traceability requirements phase in. With Brazil Compliance, companies can:
- Confidently connect to the SNCM system with an application and platform designed to meet Brazil's digital certificate and other security protocols
- Ensure the creation and submission of compliance reports based on key transactional events (shipment, receipt, etc.) as defined in the regulations
- Ensure that internal serialized inventory operations which result in compliance events are appropriately reported upon
- Enable compliance for internal transfers of product between organization and sites with different CNPJs that trigger SNCM reporting requirements
- Effectively and efficiently manage operational exceptions (receipt/shipment errors, data issues, etc.) which need rectification and corrective actions with the SNCM system
Capabilities and Features
Brazil Compliance will provide a full compliance data management system for companies needing to build a secure and flexible Brazil serialization and traceability compliance infrastructure.
- Create and configure Brazil compliance reports based on in-depth business rules and data management capabilities for event transactions which are required to be reported by ANVISA to the SNCM system including:
- Activation (creation of a unique medicine identifier for a product)
- Shipping
- Receiving
- Finalization (multiple different types)
- Replacement and Revocation (to correct and cancel previous event reports)
- Manage master data and transactional event data which is unique to Brazil serialization and traceability regulations
- Configure specific rules and data management for unique report requirements depending if products were produced outside Brazil and imported, or domestically manufactured
- Integrate with and trigger automated submission of reports to the Brazil SNCM compliance system based on configured operational triggers or submit and manage reports through the rich UL
- Archive and enable search for and retrieval of information, events, and reports sent to the SNCM system for up to 1 year after product expiry
Related Product Information
