TraceLink Track and Trace
tracelink.com
What it is
TraceLink Track and Trace provides serialization and traceability for pharmaceutical manufacturers exchanging compliance data with contract manufacturers and downstream partners. Its workflows span serialization generation, labeling, aggregation, decommissioning, destruction, scanning, shipping, verification, and compliance. The serialization solution manages processes from a single platform, with configurable automation and support for high-volume transactions. Companies can run multinational compliance centrally or distribute work among affiliates and distributors, using country-specific modules to extend into new markets. The TraceLink network lets customers and trading partners integrate once and interoperate with others through point-and-click configuration. Integrations support EDI in ANSI X12 and EDIFACT formats, SAP IDoc, XML API, email, and SFTP. TraceLink says automatic updates address evolving regulations, guidelines, technical standards, software, and workflows. It also describes 24x7 support and automatic upgrades and releases. Security measures include encryption in transit and at rest, backups, monitoring, vulnerability management, and incident response; listed independent assessments and attestations include ISO 27001 and ISO 27017, SOC 2 / ISAE 3000 Type II, and penetration testing. Pricing is on request.
Spec sheet
- What it does
- The Track and Trace suite provides global serialization and traceability for pharmaceutical manufacturers and connects them with contract manufacturers and downstream partners to exchange compliance data.Read 2 Oct 2026 · tracelink.com
- Intended users
- The Track and Trace for Pharmaceutical Manufacturers suite is aimed at pharmaceutical manufacturers managing global serialization and traceability requirements with CMOs and downstream supply-chain partners.Read 2 Oct 2026 · tracelink.com
- Integrations
- TraceLink's integration framework supports EDI in ANSI X12 and EDIFACT formats, SAP IDoc, XML API, email, and SFTP.Read 2 Oct 2026 · tracelink.com
- Security
- TraceLink says Customer Data is encrypted in transit and at rest, and its security measures include backups, monitoring, vulnerability management, and incident response.Read 2 Oct 2026 · tracelink.com
- Support
- TraceLink describes its serialization solution as offering 24x7 support and automatic software upgrades and releases.Read 2 Oct 2026 · tracelink.com
- Headquarters
- Wilmington, Massachusetts, United StatesRead 28 Sep 2026 · tracelink.com
- Founded
- 2009Read 28 Sep 2026 · tracelink.com
- Browser access
- TraceLink lists supported web browsers including Google Chrome, Microsoft Edge, Mozilla Firefox, and Apple Safari, and mobile browsers including Chrome Mobile and iOS Safari.Read 2 Oct 2026 · tracelink.com
- Compliance updates
- Automatic updates support evolving global regulations, guidelines, technical standards, software, and workflows.Read 2 Oct 2026 · tracelink.com
- Global operations
- The serialization solution supports centralized multinational compliance or a distributed model for affiliates and distributors, with country-specific modules to extend into new markets.Read 2 Oct 2026 · tracelink.com
- Partner connectivity
- The TraceLink network lets customers and trading partners integrate once and interoperate with others on the network through point-and-click configuration.Read 2 Oct 2026 · tracelink.com
- Scale
- TraceLink says its platform architecture uses Amazon Web Services to manage hundreds of millions to hundreds of billions of transactions daily.Read 2 Oct 2026 · tracelink.com
- Security assurance
- TraceLink lists ISO 27001 and ISO 27017, SOC 2 / ISAE 3000 Type II, and penetration testing among its independent security assessments and attestations.Read 2 Oct 2026 · tracelink.com
- Serialization management
- TraceLink Serialization supports managing serialization processes from a single platform, high-volume transactions, and configurable automated workflows.Read 2 Oct 2026 · tracelink.com
- Serialization workflows
- It supports serialization generation, labeling, aggregation, decommissioning, and destruction, as well as scanning, shipping, verification, and compliance processes.Read 2 Oct 2026 · tracelink.com
Plans and prices
Strong points and limits
Strong points
- Covers serialization through verification and compliance workflows.
- Supports centralized or distributed global operations.
- Country-specific modules extend into new markets.
- Integrations include EDI, SAP IDoc, XML API, email, and SFTP.
- Describes 24x7 support.
Limits
- Pricing is available on request.
- The stated target users are pharmaceutical manufacturers.
- Global compliance may require country-specific modules.
Who it suits
It is aimed at pharmaceutical manufacturers managing global serialization and traceability with contract manufacturers and downstream supply-chain partners. Its centralized or distributed operating models accommodate different approaches to multinational compliance.
Verdict
TraceLink combines serialization workflows, partner connectivity, global operating options, and multiple integration formats. Pricing is not published, so manufacturers will need to contact TraceLink for details.
Where Specifiction places it
- Product Traceability Software#22 of 277.1