Pharmaceutical
Compliance with global regulations for the track and trace of prescription drugs, like the DSCSA provisions of the US FDA’s DQSA, and the EU’s Falsified Medicines Directive, present a vast set of challenges for the pharmaceutical industry. While these serialization, e-pedigree and registration schemes have been mandated to provide consumer protections, building an integrated, interoperable supply chain while also staying abreast of evolving regulations requires a new approach to data management. As manufacturers implement their traceability programs, though, they’re also uncovering strategic value to their business: A well-deployed program can capture better visibility to the supply chain, reduce waste in procurement and warehousing, and streamline overall systems.
Labeling processes are crucial to serialization and e-pedigree program deployment. Having the right labeling system in place — one that is secure, proven and reliable; that integrates completely with existing systems and workflows to enable single source of truth data management; and that scales and adapts to evolving business practices — can be the difference between a successful serialization initiative that creates efficiencies and a complicated one that creates costs.
QTE Solutions offers Seagull Scientific BarTender Enterprise Automation labeling software as a secure component of validated installations at pharmaceutical manufacturers and packagers around the world. The Pharmaceutical industry chooses BarTender for its ease of deployment and configurable technology.
Integration
Seamless integration with ERP systems like Oracle and SAP enable automation at the enterprise level, providing increased labeling accuracy and discipline while also improving efficiencies throughout the supply chain.
Control and compliance
The centralized control in BarTender’s Enterprise Automation connects your business data with a wide variety of printers and marking devices — whether you have one printer device at a single site or thousands of printers at facilities around the world. BarTender provides a secure audit system that maintains regulatory compliance. BarTender includes over 95 different symbologies, including GS1’s linear and Data Matrix pharma barcodes and traditional linear, two-track, 2D and color Pharmacodes.
Security
BarTender meets the security demands of the pharmaceutical industry, providing full audit trail capabilities throughout the entire labeling process. BarTender provides layers of customizable settings with broad protections, providing security features ranging from simple print-only settings to complex role-based permissions and label format encryption.
Flexibility
Regulatory and production landscapes will continue to evolve and BarTender’s Intelligent TemplatesTM enable you to rapidly transform your designs, formats and processes With custom serialization capabilities, BarTender enables full compliance with global track and trace labeling requirements.
