DIAMIND Sentry Helps Manage Pharma Manufacturer's Exception Traceability Requirements

July 8, 2024

DIAMIND Sentry from Antares Vision helps pharma manufacturers stay on top of the FDA's Drug Supply Chain Security Act by quickly identifying and resolving product data exchange errors between partners.

Related To: Antares Vision Group

DIAMIND Sentry platform for pharma exceptions

Antares Vision Group's DIAMIND Sentry allows pharma companies to efficiently manage the growing exceptions stemming from traceability mandates. The sophisticated system was developed by rfxcel, a business unit of Antares Vision Group providing supply chain visibility solutions.

The implementation of widespread traceability regulations, most notably the U.S. Food & Drug Administration's Drug Supply Chain Security Act (DSCSA), requires the electronic exchange of unit-level product data, amplifying the volume of infomation shared among manufacturers, wholesalers, and dispensers. However, any errors during these exchanges result in compliance exceptions, and a significant increase in these has created industry-wide challenges.

DIAMIND Sentry addresses these obstacles by allowing for better collaboration and ensuring regulatory compliance every time.

The cloud-based platform allows manufacturers, wholesalers, and dispensers to quickly identify and resolve product data exchange errors. The system's management capabilities do not require platform upgrades, making it easier for faster deployment.

It automatically evaluates inbound and outbound Electronic Product Code Information Services (EPCIS) files through multiple prechecks, including format and master data validation, ensuring they meet DSCSA standards. Files that fail any checks generate detailed validation reports. Depending on the error's criticality, files are either blocked, flagged for review, or sent back to partners for correction. Automated notifications and ticketing systems help to quickly resolve these issues, letting users and partners respond directly via email to trigger automated responses and reprocessing.

Throughout the process, customizable dashboards provide real-time visibility into data flows, exception statuses, and purchase order tracking.

Features:

Ensures all file transactions meet DSCSA requirements for traceability and security
Automated processes maintain compliance and reduce the risk of penalties
Automated file evaluations ensure data accuracy and integrity
Detailed validation reports streamline error identification and resolution
Provides automated notifications and ticketing for communication
Compatible integration with existing systems like ServiceNow and Salesforce via APIs
Real-time dashboards monitor file success/failure rates and purchase order statuses with alerts for missing or erroneous files
Eliminates manual tracking, handling, and reporting
Accessible on mobile and desktop devices with customizable views
Serves as a single access point for all exception-related data
Reduces response times and improves efficiency
Provides global network visibility for multi-region operations