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SPECIFICTION
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TraceLink Digital Network Platform

tracelink.com

WebAPI
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Spec score 7.2 #22 of 36 in Supply Chain Management Software

What it is

TraceLink Digital Network Platform is a cloud, web and API platform for organizations coordinating life sciences and healthcare supply chains. Its OPUS environment supports demand planning, supplier management, logistics planning and fulfillment management. OPUS Solution Designer lets cross-functional teams configure user experiences, data objects and process workflows without code. Internal systems and external partners can exchange data through standard or company-specific transforms, including AS2, SFTP and SMTP file connections. Link Actions connect TraceLink applications with ERP, QMS and WMS systems, with NetSuite and Microsoft Dynamics given as examples. A unified data model harmonizes partner and network information for sharing and analysis. Administration tools cover users, links, roles, settings and shared master data. APIs cover items, work items, lists and compliance exceptions, with implementation-team setup required. TraceLink lists SOC 2/ISAE 3000 coverage, an ISO 27001-based security system and support for specified regulated-operation requirements. Pricing is on request.

Spec sheet

Purpose
OPUS is a no-code development platform for supply chain orchestration and end-to-end digital supply chain networks.Read 7 Oct 2026 · tracelink.com
Audience
The platform is for organizations across the life sciences and healthcare supply chain.Read 7 Oct 2026 · tracelink.com
API
TraceLink provides OPUS API documentation for items, work items, lists, and compliance exceptions.Read 7 Oct 2026 · opus.tracelink.com
Security
The product page states SOC 2/ISAE 3000 coverage for security, availability, and confidentiality, backed by an ISO 27001-based Information Security Management System.Read 7 Oct 2026 · tracelink.com
Compliance
The platform is designed to support customer compliance with FDA 21 CFR Part 11, EU Annex 11, and ISPE GAMP5, among other standards.Read 7 Oct 2026 · tracelink.com
Support
TraceLink directs customers to its Technical Support contact page for assistance.Read 7 Oct 2026 · tracelink.com
Headquarters
TraceLink lists its global headquarters in Wilmington, Massachusetts.Read 7 Oct 2026 · tracelink.com
Founded
2009Read 28 Sep 2026 · tracelink.com
Administration
OPUS Administer includes tools to manage users, company and network links, roles, application settings, and shared company, partner, and product master data.Read 7 Oct 2026 · tracelink.com
API access requirement
The API guide says users should work with their TraceLink implementation team to configure their system and receive endpoints and authentication information.Read 7 Oct 2026 · opus.tracelink.com
APIs
TraceLink API documentation describes event-driven APIs for integrating OPUS apps with internal systems such as ERP and warehouse management systems.Read 7 Oct 2026 · opus.tracelink.com
Customization
OPUS Solution Designer lets cross-functional teams customize solutions, including user experiences, data objects, and process workflows.Read 7 Oct 2026 · tracelink.com
Data and analytics
OPUS uses a unified data model to harmonize partner data sharing and network-wide data for business insights.Read 7 Oct 2026 · tracelink.com
Data model
OPUS uses a unified data model to harmonize data sharing between partners.Read 7 Oct 2026 · tracelink.com
ERP integrations
TraceLink documentation describes Link Actions for communication between external systems such as ERP, QMS, and WMS and TraceLink apps, and gives NetSuite and Microsoft Dynamics as examples.Read 7 Oct 2026 · opus.tracelink.com
Integration
The platform supports interoperable data exchange with internal systems and external partners using standard and company-specific transforms.Read 7 Oct 2026 · tracelink.com
Integration protocols
OPUS B2B connections support AS2, SFTP, or SMTP for file exchange with external systems such as ERP systems.Read 7 Oct 2026 · opus.tracelink.com
Network collaboration
TraceLink describes OPUS as enabling organizations to integrate once and interoperate with key supply chain partners and customers.Read 7 Oct 2026 · tracelink.com
Network reach
The platform page says OPUS can interoperate with over 291,000 companies on the TraceLink network.Read 7 Oct 2026 · tracelink.com
Network scale
TraceLink reported 310,000+ trading partners, 339,000+ active links, and 1,790+ customers worldwide.Read 7 Oct 2026 · tracelink.com
Regulated operations
TraceLink says OPUS is designed to support customer compliance with FDA 21 CFR Part 11, EU Annex 11, and ISPE GAMP5 requirements.Read 7 Oct 2026 · tracelink.com
Security and compliance
TraceLink says OPUS has SOC 2/ISAE 3000 coverage for security, availability, and confidentiality, backed by an ISO 27001-based information security management system.Read 7 Oct 2026 · tracelink.com

Plans and prices

OPUS Digital Network Platform Priced on request Pricing not listed; contact TraceLink for details Read 7 Oct 2026 · tracelink.com

Every TraceLink Digital Network Platform plan and price →

Strong points and limits

Strong points

  • No-code workflow and data customization
  • AS2, SFTP and SMTP file exchange
  • ERP, QMS and WMS connectivity
  • Unified model for partner data
  • Cloud deployment with API access

Limits

  • Pricing requires contacting TraceLink
  • API setup needs an implementation team
  • Designed for life sciences and healthcare supply chains

Who it suits

It suits life sciences and healthcare supply-chain organizations needing partner integration, configurable workflows and regulated operations. Teams connecting ERP or warehouse systems can use its documented integration routes.

Verdict

TraceLink combines configurable supply-chain applications with partner networking, integration protocols and shared data management. Its paid, quote-based model and implementation requirements are important considerations before adoption.

Where Specifiction places it

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