Serialization is not one-size-fits-all. With varying mandates across the U.S., EU, Asia, and the Middle East, companies must navigate a complex web of requirements. Are you prepared for global compliance?
Connect products, partners, and patients in real time.
Digital Link
The Future of Connected Pharmaceuticals
Digital Link transforms standard GS1 barcodes into secure digital gateways that connect manufacturers, distributors, and dispensers to trusted product information. The solution strengthens supply chain integrity, supports patient safety, and simplifies regulatory operations across the product lifecycle.
Digital Link uses GS1 standards to convert existing serialized 2D DataMatrix barcodes into secure web links. Each scan captures the GTIN, lot, serial number, and expiration date. The system validates this data and applies routing rules to direct users to the correct workflow or information. The solution integrates with traceability, quality, and compliance systems to support a connected and streamlined operating environment.
Users are guided to the appropriate destination, such as a dashboard, recall workflow, authentication check, or reporting interface. Manufacturers can update routing rules and activate workflows in real time without changing packaging or serialization processes.
Strategic Advantages
Enhanced Patient Safety
Provide verified product information and enable rapid response to recalls and product issues.
Regulatory Alignment
Support FDA requirements through integrated recall management, traceability, and Digital Product Passports.
Operational Efficiency
Automate recalls and Return Merchandise Authorizations (RMA) to reduce manual effort and operational waste.
Supply Chain Integrity
Enable real-time verification and maintain a transparent, auditable chain of custody.
Core Capabilities
Comprehensive Recall Management
Digitize and centralize recall execution. The Recall Module integrates FDA recall data, links it to serialized products, and manages investigation, notification, and documentation from initiation through resolution.
Targeted, Rapid Response
Execute precise recalls to minimize patient risk and market disruption.
Automated Reporting
Maintain a complete, audit-ready record of recall activity.
Controlled Execution
Reduce financial impact through focused action.
Returns and Product Issue Reporting
Enable wholesalers and dispensers to report damaged or suspect products directly through the platform. Reported issues initiate a structured Return Merchandise Authorization workflow tracked from submission through inspection and resolution.
Accelerated Issue Resolution
Improve responsiveness to field-reported concerns.
Structured Returns Management
Formalize RMA tracking to reduce administrative burden.
Quality Intelligence
Aggregate issue data to identify trends and strengthen manufacturing and logistics performance.
Returns and Product Issue Reporting
A simple scan confirms product authenticity and provides controlled access to approved product information, including prescribing details, safety warnings, and patient instructions, all centrally managed by the manufacturer.
Verified Authenticity
Protect patients and brands from counterfeit or diverted products.
Reliable Information Access
Deliver accurate, current documentation at the point of dispensing or use.
Centralized Content Control
Maintain governance over product information across stakeholders.
Gain real-time visibility into supply chain performance and stakeholder engagement. Capture and analyze scan activity, recall actions, and RMA workflows to track product movement and measure recall responsiveness. Identify unusual product movement or irregular distribution patterns to strengthen oversight and improve performance across global markets.
Digital Product Passports (DPP)
Generate a comprehensive Digital Product Passport for each serialized item that provides a clear, compliant record of the drug’s lifecycle, including clinical data, FDA and European Medicines Agency approvals, manufacturing details, quality results, and documented chain of custody. This digital record supports audit readiness, improves transparency, and helps manufacturers meet evolving global compliance requirements.
Future-Ready Pharmaceutical Infrastructure
Digital Link extends the value of existing GS1 infrastructure to support proactive recalls, product authentication, structured returns, and clear lifecycle visibility. As pharmaceutical supply chains evolve, the solution helps manufacturers improve safety, meet regulatory expectations, and maintain operational control.
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By clicking “Accept All Cookies”, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. View our Privacy Policy for more information.