Serialization

TraceLink Serialization is a platform-based solution designed to help pharmaceutical and life sciences companies meet serialization and traceability requirements across dozens of global markets. Built on TraceLink's network of authenticated supply chain entities, it provides a configurable foundation that accommodates the regulatory variations, workflows, and technical standards specific to each market, reducing the time and cost associated with achieving and maintaining compliance at scale.

The solution is intended for manufacturers, distributors, and supply chain partners operating across multiple countries and regulatory jurisdictions. It supports centralized multinational compliance strategies as well as distributed models that allow local affiliates and distributors to manage their own compliance through secure platform access.

Core Capabilities

• Manages serialization processes from a single platform, consolidating oversight of serial number allocation, packaging operations, and compliance workflows across internal and contract manufacturing sites.
• Handles large datasets and high-volume transactions, scaling to millions of serialized units across dozens of markets.
• Supports configuration and automation of serialization workflows to align with market-specific regulations, product categories, and packaging aggregation requirements.
• Provides country-specific compliance modules that allow serialization processes to be extended to new markets as regulatory requirements emerge.

Regulatory and Compliance Coverage

• Supports serialization requirements in more than two dozen markets, accommodating variations in unique product identifier content and multi-level packaging aggregation rules that differ from base GS1 standards.
• Monitors global compliance initiatives on an ongoing basis and delivers regular solution updates to address new and evolving regulations, technical standards, and workflows.
• Addresses requirements related to product reporting, decommissioning, product verification, and saleable returns verification, including DSCSA compliance in the United States.
• Supports partner integration and testing workflows as new regulatory requirements introduce changes to supply chain processes.

Network Integration and Partner Connectivity

• Operates on TraceLink's digital supply network, which connects more than 290,000 members and 3,500 manufacturing and distribution partners, enabling compliance data exchange through a single connection.
• Follows an "Integrate Once, Interoperate with Everyone" model, allowing companies to connect once to the network and exchange data with all supply chain partners without repeated point-to-point integrations.
• Supports onboarding of new supply chain partners, accommodating changes resulting from partner mergers, acquisitions, and network expansion.
• Connects to packaging lines at both internal and contract manufacturing sites to centralize serial number allocation and link serialized product operations to existing supply chain operations.

Deployment and Infrastructure

• Delivered as a SaaS-based solution using a network-tenant architecture, which enables automatic software upgrades and releases without requiring complex integrations or dedicated IT support.
• Designed for system stability, with the vendor citing a track record of zero downtime and 24x7 support availability.
• Integrates with related TraceLink products including Serial Number Manager, Serial Number Exchange, Serialized Operations Manager, Master Data Sharing, and Product Information Manager.

TraceLink Serialization has been in use across segments of the end-to-end pharmaceutical supply chain for more than ten years, supporting companies seeking to manage global serialization compliance from a single, scalable platform.