Serialization, with requirements for tracking a high volume of events.
Argentina has serialization and reporting requirements but is not trying to create a trace history. Manufacturers selling product in the country must serialize every salable unit in accordance with GS1 standards for both the serial number and bar code format. Right now, only a limited number of products must be serialized, but pharma companies are required to track and report significantly more events than in many other countries, requiring probably the highest number of messages all the way through the supply network. ANMAT, the Argentinean Health Authority, is the government agency managing the regulations.
Handling Argentina’s demands while maintaining operational efficiency.
The TraceLink solution manages all ANMAT format and messaging requirements, allowing pharma companies to run their operations while we look at the mass data and determine what the right messages are, which modules need to be alerted, and what format to create. Then we send it off to the right authority or trading partner.
In addition, the TraceLink solution supports:
- Managing ANMAT traceability reporting requirements from a single platform.
- Easily adapting to evolving regulatory requirements with minimal change and disruption:
- Maintaining connection profiles to ANMAT for purposes of receiving reports.
- Managing regulatory recordkeeping and retrieval.
- Viewing notifications sent, receipts, and exceptions received from ANMAT.
- Communicating information to ANMAT about production, shipments, receipts, destruction, and product status changes (e.g., loss, theft, recall).
- Configuring email alerting on exceptions.
- Searching ANMAT messages based on product, lot, event, serial number, date range, trade partner.
- Drilling down to view ANMAT report details.