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TraceLink

by TraceLink Inc. · Healthcare & Life Sciences

Cloud track-and-trace and serialization network for pharmaceutical supply chains.

Updated August 2026 · By the ERP Research Editorial Team · Independent and vendor-neutral.

Works with
SAPOracle
Deployment
Cloud
Company size
Mid-market, Enterprise
Pricing
Subscription
Founded
2009
Headquarters
Wilmington, Massachusetts, United States

Overview

TraceLink is a life-sciences supply chain software company founded in 2009 and headquartered in Wilmington, Massachusetts. It operates what it describes as the world's largest track-and-trace network for pharmaceutical serialization and compliance, connecting manufacturers, contract manufacturers (CMOs), 3PLs, wholesalers and specialty pharmacies onto a single multi-tenant cloud network.

The company's Opus Digital Network Platform hosts a family of applications including Serial Number Manager, Serialized Operations Manager and Serialized Product Intelligence for generating, aggregating, decommissioning and reporting on serialized product data, plus the POET workflow design tool and Opus Link Lab for building custom multienterprise solutions without code. TraceLink markets coverage of DSCSA and more than 40 countries' serialization mandates through its EPCIS-based exchange.

Pharmaceutical manufacturers typically connect TraceLink to their ERP systems, commonly SAP or Oracle, to send product master data out and receive serialized numbers back; TraceLink documents SAP ATTP integration patterns and has published guidance on supporting SAP ECC to S/4HANA migrations for serialization data. Pricing is subscription-based and not publicly listed.

Screenshots & demo

Demo video from the vendor's YouTube channel.

Features & capabilities

Serialization & Compliance

Core DSCSA and global serialization mandate compliance tooling.

  • Serial Number Manager
  • Serialized Operations Manager
  • DSCSA compliance workflows
  • EPCIS data exchange
  • Country-specific regulatory compliance (40+ markets)
  • Aggregation, decommissioning and destruction workflows

Track & Trace Network

The Opus Digital Network of pre-connected trading partners.

  • Opus Digital Network (290,000+ connected entities)
  • Trading-partner onboarding
  • Multi-tenant cloud architecture
  • Single integration to reach the full partner network

Supply Chain Orchestration

Multienterprise workflow orchestration beyond compliance.

  • Order-to-cash orchestration
  • External manufacturing data exchange
  • Agile Process Teams collaboration workflows
  • Agentic supply-chain workflow capabilities

Platform & Development Tools

No-code tooling for building custom network solutions.

  • Opus no-code development platform
  • POET workflow design tool
  • Opus Link Lab design environment
  • MINT application family

Analytics & Reporting

Reporting on serialized product movement and intelligence.

  • Serialized Product Intelligence
  • Serialized product reporting

Common use cases

  • Meeting DSCSA serialization and traceability mandates for US pharmaceutical distribution
  • Complying with country-specific serialization mandates across 40+ global markets
  • Onboarding contract manufacturers (CMOs) and 3PLs onto a shared track-and-trace network
  • Exchanging serialized master data and serial numbers between SAP or Oracle ERP and trading partners
  • Managing EPCIS data exchange with wholesalers and specialty pharmacies
  • Orchestrating order-to-cash workflows across a multi-enterprise pharmaceutical supply chain
  • Migrating serialization integrations during an SAP ECC to S/4HANA transition

Strengths & considerations

Strengths

  • Large pre-existing trading-partner network (290,000+ entities) reduces per-partner integration effort
  • Purpose-built no-code Opus platform for building custom multienterprise workflows
  • Broad global regulatory coverage across 40+ country serialization mandates
  • Documented integration patterns for SAP (including SAP ATTP) and Oracle ERP environments

ERP integrations

Prebuilt connector (SAP ATTP integration)Bi-directional

Exchanges master data and serial numbers; TraceLink publishes guidance for SAP ECC to S/4HANA migrations

Prebuilt connectorBi-directional

Pricing

Model
Subscription
Free trial
No

Scope-based pricing driven by Opus modules used, MINT connections, onboarding services and data-residency requirements; not publicly listed. Get an independent shortlist with pricing guidance below.

Technical & security

Hosting
SaaS (multi-tenant)

About the vendor

Founded
2009
Headquarters
Wilmington, Massachusetts, United States
Employees
~1,000
Ownership
Private (venture-backed)

Alternatives to TraceLink in Healthcare & Life Sciences

TraceLink — frequently asked questions

What is TraceLink used for?

TraceLink is used by pharmaceutical manufacturers, CMOs, wholesalers and pharmacies to meet DSCSA and international serialization mandates and to exchange track-and-trace data across the supply chain.

Does TraceLink integrate with SAP or Oracle ERP?

Yes. Manufacturers commonly connect TraceLink to SAP (including via SAP ATTP integration patterns) or Oracle ERP to send master data and receive serialized numbers back.

How large is TraceLink's trading-partner network?

TraceLink reports more than 290,000 connected trading-partner entities on its Opus Digital Network, so a single integration can reach the broader network.

How is TraceLink priced?

TraceLink uses subscription pricing scoped to the Opus modules used, MINT connections and onboarding services; specific price points are not publicly listed.

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