To date, much less focus has been placed on the pharmacy requirements ahead of the November 2023 compliance deadline
Systech, part of Markem-Imaje and Dover (NYSE: DOV), and a leading provider of digital identification and traceability software solutions, today announced the availability of Systech UniTrace DSCSA for Pharmacies and Dispensers. Available in three distinct package levels, this new solution enables pharmacies and other dispensers to gain the capability to acquire, validate, and retain electronic transaction information (TI) that encompasses unit-level serialization data and transaction statements (TS) supplied by their vendors to meet DSCSA compliance. Following receipt, dispensers are equipped to completely access, examine, verify, and distribute necessary compliance data as requested by regulatory entities or business associates, all via one unified platform.
One of the key elements for pharmacies to understand is that the DSCSA creates a digital representation of the physical supply chain. They will now be getting transaction data that reflects the shipments coming to them from the wholesalers. Historically, pharmacies have checked and reconciled shipment notices to validate that the product received at each pharmacy matches the shipment notice and order. Following November 27, the regulation requires pharmacies to validate that the serial numbers of the products received match the serial numbers in the electronic record sent.
Systech has proven itself over decades in the highly regulated and rigorous pharmaceutical arena with reliable and configurable packaging execution systems and serialization software. With the advent of DSCSA, Systech has led the way in delivering technology solutions that enable DSCSA compliance. The Systech platform can uniquely create product data at the line level and deliver meaningful value from that data throughout the supply chain. Systech provides a complete traceability solution across the pharmaceutical supply chain ecosystem, from manufacturers, contract manufacturing organizations (CMOs), contract packaging organizations (CPOs) and distributors, to third-party logistics providers, pharmacies and regulatory bodies.
“To date, the main focus in the industry has been the role that manufacturers and wholesalers play, their data integration requirements and their level of readiness for the final phase of interoperability requirements coming with the November deadline,” said Girish Juneja, Senior Vice President and Chief Digital Officer of Dover. “This new offering is another example of how Systech is committed to helping pharmacies of all sizes become DSCSA compliant. Systech UniTrace for Dispensers is the solution to simplify their compliance workflows and streamline their pharmacy operations.”
With Systech UniTrace DSCSA for Dispensers, healthcare and retail pharmacies can choose one of three package levels, basic, advanced and enterprise. The basic package is a complete, turnkey DSCSA compliance solution for smaller pharmacies that may not have the resources to invest in new technology or specialized personnel. The advanced offering is suitable for mid-sized dispensers featuring capabilities such as scanning, automation, expiry management and other useful features. The enterprise solution is ideal for large organizations or high-volume dispensers seeking multi-level management, multi-system integrations, custom reporting and data analytic capabilities.
Deployed in thousands of global implementations, Systech’s comprehensive platform enables customers to address regulatory and business requirements by knowing what happens to a given product at every stage of its journey. Systech’s easily configured, turnkey solutions work seamlessly together and integrate with other identification and traceability solutions.
To learn more about Systech UniTrace DSCSA for Dispensers and Pharmacies, click here.
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