Falsified and counterfeit drugs can place public health as well as pharmaceutical brands in danger. Thus, in order to avoid any risks posed by these drugs, the US FDA’s Drug Supply Chain Security Act (DSCSA) and the EU’s Falsified Medicines Directive (FMD) have mandated serialization—unique identification of individual packs of medications—of pharmaceutical products. Consequently, the industry now faces increased supply chain scrutiny and compliance issues, which has been a major roadblock for drug manufacturers and contract packagers, who find it difficult to maintain compliance and the requisite supply chain traceability. BarTender®—a labeling and barcoding software—supports these companies by providing protection against counterfeit medicines and allowing them to create as well as automate labels, barcodes, and RFID tags.
Washington-based Seagull Scientific has developed BarTender taking global pharmaceutical traceability compliance and change management into consideration. It offers unparalleled security, serialization, and centralized management capabilities that make it an ideal choice for pharmaceutical manufacturers and contract packagers. BarTender ensures that these companies enjoy a seamless connection between their data sets irrespective of whether they are stored in SAP, Oracle, or proprietary database. Customers can even deploy design, data, and format changes using BarTender’s Intelligent Templates™, which provides the agility required for better change management practices. This functionality allows companies to safeguard their product templates and configure user access based on a product, container, geography, business unit, operator, or other parameters as per their business needs.
Seagull Scientific helps pharmaceutical companies keep their supply chain safe, as well as meeting the evolving regulations and practices. The company ensures that its software manages the mission-critical labeling processes such as security, user access, barcoding and RFID encoding, serialization, e-signatures, and complete audit trail. Seagull Scientific’s effective ways of managing different labeling processes can be illustrated with an example of a multinational pharmaceutical manufacturer that was struggling with its inefficient label generation. The client was in need of a fully automated labeling system in order to streamline its operations. After evaluating available options, the firm chose to deploy an enterprise label management system that included BarTender as an integrated component. This integrated management system provided label template, barcoding, and design interfaces along with unparalleled printer support via a browser-based printing solution. BarTender reduced manual errors in labeling processes while securing and improving the manufacturer’s ability to comply with global regulations.
Akin to the multinational pharmaceutical manufacturer, Seagull Scientific has been assisting a vast customer base of Fortune 500 companies that includes the ten largest pharmaceutical manufacturers and topmost contract packagers. Besides, it works in close collaboration with GS1—a non-profit standards organization—to help its customers comply with US FDA’s DSCSA and other global traceability regulations. Seagull Scientific has embedded automated tools and wizards in BarTender to generate precise GS1 linear and 2D barcodes. BarTender also includes several barcode symbologies that are significant to pharmaceutical companies such as 2D Pharmacode, Code 32, Pharmacode one-track, Pharmacode two-track, and Pharma-Zentral-Nummer (PZN).
To steer the evolution of BarTender ahead, Seagull Scientific will continue to collaborate with both its pharmaceutical customers and global regulatory agencies. “Our contribution to protecting the world’s medicines is critical—we ensure that our product development always anticipates and complements customer requirements,” mentions Boe. Seagull Scientific’s goal is to understand the necessary product capabilities even before the industry realizes the new requirements.