Today’s Supply Chain Challenges Exist Across the Supply Network
Globalization and the quest for cost reduction has brought incredible efficiency and cost savings to supply chains. But they have also increased risk and made supply chains more brittle.

- Disruptions: e.g. Shipment delays
- Traceability: e.g. Anti-counterfeiting and diversion
- Transparency: e.g. Product availability and recalls
- Sustainability: e.g. Digital leaflets
- Social Responsibility: e.g. Supplier management
- Global Demand Fluctuations: e.g. Material shortages
Meet Today’s Challenges with TraceLink’s Industry 4.0 Capabilities
Industry 4.0 blurs the lines between the physical and digital worlds using modern smart technology, large scale machine-to-machine learning, and the Internet of Things. Connecting people, processes, systems and data with digital networks that respond to patient demand. Adapt to fluctuations in supply. And enable network members - collectively - to act more intelligently than any person, group or computer has ever done before.
The TraceLink Opus Platform delivers the capabilities required for Industry 4.0 supply chain transformation
- Create dynamic and secure digital networks to share information with partners
- Share processes across newly digitalized business networks with shared (multienterprise) applications
- Drive cross-functional and cross-company execution with shared but customized solutions that meet the workflow and data needs of each company and its partners
- Leverage a common data model that can take master data from existing enterprise systems and auto-translate the data into a common language for use by partners and shared applications
- Generate collective intelligence from the data generated across the network of networks thanks to shared processes/applications and a common data model

TraceLink's Opus: The Platform for the Internet of Supply Chains™
Opus is a low-/no-code development platform and partner ecosystem for constructing digital networks for Industry 4.0 deployments. It provides capabilities at each of five distinct layers that are required to build, manage, and grow interoperable digital networks with and among supply chain partners.

Solutions: Capabilities for customizing apps to create unique user experiences, workflows, data objects, roles, permissions, and more, thereby creating company-specific configurations while also maintaining network interoperability with partners using those shared applications.
Opus Platform services included:
- Solution Builder
- Solution Marketplace and Partner Ecosystem
- Solution Training

Applications: Capabilities for building new or leveraging existing multienterprise apps which link supply chain partners across shared networks, thereby creating digital networks of shared business processes for execution excellence.
Opus Platform services included:
- TraceLink Development Environment for multienterprise app design
- Application Administration for network interoperability
- Metadata Manager
- Workflow Manager
- Messaging Processing Framework

Information: Capabilities for leveraging metadata applied to all business objects across the network through existing data mesh pipelines, thereby enabling machine learning out-of-the-box to create industry-wide predictive analytics and collective intelligence.
Opus Platform services included:
- Data Mesh Pipeline
- Machine Learning Tools

Integration: Capabilities for deploying APIs, Plug-ins, B2B data exchange, and other information sharing protocols through canonicalized messaging, thereby creating an interoperable business transaction network that can scale to companies of any size or digital maturity.
Opus Platform services included:
- Message Hub for interoperable information exchange among network partners
- Transformation Service for metadata and canonical data definition and mapping
- Integration and Plug-in Marketplace

Network: Capabilities for creating and managing interoperable networks of authenticated companies, users, products, and partners; provides for securely managing and administering company, partner, and product master data, thereby creating a single source of truth for network master data.
Opus Platform services included:
- Network Onboarding
- Company Administration
- User Administration
- Network Master Data Management
TraceLink Powers Pharmaceutical Track & Trace - A Global Industry 4.0 Success Story
As early as 2010, the TraceLink team realized that governmental track and trace regulations would necessitate the creation of a digital network platform to enable network members to create and manage serialized identities for saleable product across the supply chain as well as exchange serialized data and traceability information with direct and indirect trade partners.
TraceLink created the largest digital network platform in the industry powering the most successful Industry 4.0 implementation to date.
- 1,300 customers and 285,000 authenticated and onboarded network members
- 816 million regulatory documents processed and exchanged
- 30+ billion serial numbers commissioned to date
- 13,925 live serialization connections
- 7,035 live CMO connections
- $4.6 billion in customer savings by avoiding point-to-point integrations

Your Platform Ecosystem for Supply Chain Transformation
No company can hope to address the problem of escalating demand and supply variability in isolation. The Opus platform fills the gap between silo’d enterprise systems, teams, and data and enables collaboration and orchestration between your extended network of customers and suppliers.
The Opus platform enables manufacturers, suppliers, distributors, 3PLs, retailers / health systems, and independent software developers to quickly design, build and customize multienterprise applications with little or no coding. Putting the power of innovation in the hands of supply chain practitioners, coupled with a growing ecosystem of third party supply chain apps on the platform, will unleash transformative end-to-end supply chain digitalization.
Leverage the Collective Intelligence of a Network of Networks
Network members - collectively - act more intelligently than any person, group or computer has ever done before. Transform decision making with intelligence gathered from a network of networks.
- Eliminate shortages
- Prevent disruptions
- Link supply plans with real-time consumption insights
- Improve product launch performance
- Reduce inventory
- Maximize profitability

Supply Chain Work Management: Your First Step in The Journey to Industry 4.0 Transformation
Maintain agility in the face of demand fluctuations and unpredictable supply. Agile Process Teams, a multi-enterprise application built on TraceLink’s low-code/no-code Opus™ digital network development platform, allows any company in the supply chain to build collaborative networks across their trading partners to enhance the performance of their integrated supply planning and execution processes through better management of supply chain issues and planning exceptions like material shortages, short shipments, and forecast changes.
TraceLink offers a complete Supply Chain Work Management solution within the APT application. With Issue Management, Task Management, Change Requests, Document Review, Quality Document Review, and Batch Record Review capabilities, Supply Chain Work Management gives operational leaders a platform to monitor and improve the quality of the supply plan to ensure that they achieve the highest customer delivery levels at the lowest cost.

Respond faster to planning exceptions through integrations with leading planning systems and a more efficient process powered by workflow driven notifications, reminders, due dates, and alerts. Use performance data to reduce recurring issues with continuous process improvement.

Respond faster to planning exceptions through integrations with leading planning systems and a more efficient process powered by workflow driven notifications, reminders, due dates, and alerts. Use performance data to reduce recurring issues with continuous process improvement.

Respond faster to planning exceptions through integrations with leading planning systems and a more efficient process powered by workflow driven notifications, reminders, due dates, and alerts. Use performance data to reduce recurring issues with continuous process improvement.
TraceLink: A Heritage of Solving Traceability and Compliance Challenges
Since 2009, TraceLink has been the industry leader in delivering track- and -trace solution to meet regulatory requirements in more than 30 countries for the global pharmaceutical industry. With more than 287,000 trading partners on our digital supply network, TraceLink lets companies Integrate Once, Interoperate with Everyone™ for seamless data exchange and fast trade partner onboarding.
Today, TraceLink’s Opus Platform harnesses the data created by multienterprise applications to address challenges in regulatory compliance, recalls, and product shortages. Powered by the Opus Platform, Product Availability Intelligence applies machine learning to the movement of more than 30 billion serialized medicines across the TraceLink network to predict shortages 90 days in advance with greater than 80% accuracy.
TraceLink can help you comply with new and evolving regulations around the world—and we continuously monitor worldwide regulatory requirements to be sure your compliance solutions stay up to date.
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