Product: TraceLink serialization: Serial Number Manager (SNM), Serialized Operations Manager (SOM), and the related products on the same pages (Serial Number Exchange, Product Information Manager, Master Data Exchange, Smart Inventory Tracker). TraceLink also sells the OPUS platform, MINT, POET, and what it calls an agentic supply-chain network. This profile covers those only where a source ties them to serialization. Vendor: TraceLink, Inc. The website terms give a copyright-agent address at 400 Riverpark Drive, North Reading, MA 01864, under Massachusetts law. The February 2026 press release is datelined Boston. The company history starts in Cambridge. Category: Pharmaceutical serialization and track-and-trace / supply-network software. Adjacent. SOM manages serialized inventory events in packaging, warehouse, and distribution. It is not an MES, a LIMS, or a QMS. Verification date: 2026-10-03. Scope: Public sources only.

1. Overview

TraceLink is a serialization and DSCSA compliance network: Serial Number Manager issues serial numbers, and Serialized Operations Manager records serialized packaging, warehouse, and distribution events across manufacturers, CMOs, 3PLs, and trading partners. It is adjacent to MES because it runs beside packaging and warehouse systems with no batch record or batch release, and it is bought by pharmaceutical manufacturers, CMOs, contract packagers, and distributors that must exchange serialized data with governments and trading partners.

TraceLink says the products let companies "meet serialization requirements in dozens of markets" and "scale serialization over millions of units." (Serialization.)

Serial Number Manager generates, imports, replenishes, and provisions serial numbers for saleable units, bundles, cases, and pallets. Templates cover GS1 SGTIN and SSCC, proprietary formats such as CN-EDMC, and "special scenarios such as Russia Crypto Codes." (SNM.)

Serialized Operations Manager is "a serialization repository and operational hub in packaging, warehouse, and distribution activities." It covers receiving, pick/pack and ship, commissioning and aggregation, status updates, rework, relabeling, sampling, and destruction, including at CMO and 3PL partners. (SOM.) The February 2026 release adds hospitals and pharmacy systems to the DSCSA story.

Boundaries:

• Not an MES. SOM exchanges data with ERP and WMS. Its page describes no master batch records, equipment logbooks, or batch release.
• Not the whole TraceLink network. The about page's 2025–present chapter is an "Agentic Supply Chain Operating System" on OPUS, with MINT and POET named for earlier transaction and process digitalization. The release says customers are broadening use "beyond regulatory requirements."
• Not a renamed ePedigree tool. The 2005 ePedigree application came before the 2009 rename. Current pages sell SNM and SOM.

2. Company and product identity

Point	Fact	Source
Website party	TraceLink, Inc. Site terms are governed by Massachusetts law, with exclusive jurisdiction in Massachusetts courts.	Website terms
Address	400 Riverpark Drive, North Reading, MA 01864, Attn: General Counsel. This is the DMCA contact.	Same terms
Founding	2003: SupplyScape, "out of MIT," Cambridge, Massachusetts. 2005: first ePedigree compliance application. 2009: renamed TraceLink.	About
Leadership	Shabbir Dahod, Founder, President and CEO, plus chief commercial, financial, technology, and people officers.	About
Board	Directors labeled Georgian Partners, Volition Capital, Nestlé, FirstMark Capital, Goldman Sachs, and Resonance, plus an audit-committee chair. No ownership or round sizes published.	About
Product family	Serial Number Manager, Serial Number Exchange, Product Information Manager, Serialized Operations Manager, Master Data Sharing. Smart Inventory Tracker is linked for DSCSA shipping and receiving; its product page was offline on 3 Oct 2026.	Serialization index
OPUS	2025–present: OPUS platform, agentic business processes, control towers. OPUS expanded in 2025 as the information foundation.	About; PR Newswire, 27 Feb 2026
Integrate-Once	2017–2021: companies "link once" to the network. TraceLink claims this eliminated "billions in integration cost," with no study, baseline, or currency.	About

The website terms govern the site, not a serialization order form. The SaaS subscription agreement is not public on the pages reviewed.

3. Pharma and supply-chain relevance

TraceLink's regulatory fit is serialization and traceability law, not GMP batch execution.

• Identifier formats. SNM templates carry GTIN-14, NTIN, company prefix, and site-specific ranges. Vendor claim; no regulator certificate. (SNM page.)
• DSCSA in 2025. The 27 February 2026 release says TraceLink and "its 310,000+ network of customers and trading partners" executed the U.S. DSCSA dispenser milestone in 2025, integrating with ERP, WMS, serialization, and pharmacy systems including SAP, Oracle, and Manhattan. The release defines 310,000+ as trading partners and counts "1,790+ customers" separately. It does not name the FDA or cite a statute. (PR Newswire.)
• Compliance reporting. SOM lists commissioning, aggregation, shipping, receiving, sampling, destruction, status, and "compliance report submission." It names no government systems. (SOM page.)
• CMO and 3PL scope. SNM replenishes serials into a partner's repository, and SOM operations run at partner sites. Neither page says TraceLink operates the partner's plant. (SNM; SOM.)

4. Capabilities

Capability	Status	What the page says	Source
Serial number generation	Native to SNM	Random and sequential; rules-based templates; CSV or UI; thresholds and quantities.	SNM page. Vendor.
Packaging hierarchies	Native to SNM	Saleable unit, bundle, case, pallet.	SNM page.
External replenishment	Native to SNM	From supply partners or government systems, and from a manufacturer repository to a CMO or packager repository.	SNM page.
Serialized inventory events	Native to SOM	Receiving, pick/pack, ship, commissioning, aggregation, status, rework, relabel, sample, destroy.	SOM page.
Partner operations	Native to SOM	"across plant and warehouse operations, including CMO and 3PL partners."	SOM page.
Compliance report submission	Named on SOM	"asynchronous workflows for serialization data exchange, compliance report submission, and more." No country list.	SOM page.
EPCIS	Integration target	Exchange with ERP, WMS, distribution systems, or third-party EPCIS repositories through standardized APIs. EPCIS version not stated.	SOM page.
Edge and mobility	Named	"Integrate mobility and edge devices with our standardized API." No device list.	SOM page.
Smart Inventory Tracker	Named	Linked for DSCSA shipping and receiving. Product page offline on 3 Oct 2026.	Serialization index.
Batch record execution	Absent	Not on SNM or SOM.	Gap

5. Architecture and deployment

• SNM is a "centralized, flexible platform." SOM is a "centrally maintained operational repository" and a "single hub." Neither page states cloud or on-premises, a database, or a region. (SNM; SOM.)
• MINT, POET, and track-and-trace share an "OPUS Metadata Model," and the current system runs on OPUS. (About.)
• SOM APIs and workflows run synchronously or asynchronously. (SOM.)
• The about page links a Trust Center. This profile cites no SOC or ISO certificate.

Not published: uptime SLA, RPO/RTO, encryption, customer-selectable data region.

6. Integrations

Kind	Fact	Weight
SOM standardized API	See section 4.	Vendor claim. No public message catalog.
SNM partner and government exchange	Import, replenishment, and push to CMO or CPO repositories "via TraceLink."	Network function. No government endpoint list.
February 2026 release	"leading ERP, WMS, serialization, and pharmacy systems — including SAP, Oracle, Manhattan, and other major enterprise platforms."	Names in a company release, not an interface specification, and not limited to serialization products.
Integrate-Once	One network connection instead of point-to-point links.	Company model. The "billions" figure is unsupported.
Master Data Exchange	Named in the SNM page footer.	Separate product.

7. Pricing and commercial model

Price: quote-only. SNM and SOM pages say "Contact Us." TraceLink publishes no price table, and the website terms state no fee.

• The release reports 1,790+ customers, 310,000+ trading partners, and 339,000+ active links. Scale claims, not prices. (PR Newswire.)
• SNM, SOM, exchange, product information, and master data are sold under separate names. The pages do not say whether they form one subscription. (Serialization index.)
• Searches on 3 Oct 2026 found no award naming TraceLink on USAspending (contracts from 1 Oct 2007), EU TED, or SAM.gov opportunities. UK Contracts Finder's keyword filter returned only unrelated notices, so no UK result is reported.

Questions a buyer should ask

1. Which of SNM, SOM, Serial Number Exchange, Product Information Manager, Master Data Exchange, and Smart Inventory Tracker are in the quote?
2. What is the metric: site, line, serial volume, trading partner, or network link?
3. Are government reporting connections for each market included or extra?
4. Does the CMO or 3PL need its own subscription, or does the manufacturer's cover the partner repository?
5. Which EPCIS version and which ERP or WMS messages does the "standardized API" cover?
6. What is hosted where, and is OPUS a separate fee?
7. What changed for DSCSA dispenser workflows in 2025, and what stays the customer's procedure?
8. Are Russia Crypto Codes and CN-EDMC in the base templates or a country pack?
9. Who authors validation evidence for a packaging-line integration?
10. What does the order form say? The website terms govern only the site.

8. Implementation and validation support

TraceLink publishes no implementation timeline, GAMP 5 category, or validation pack for serialization. The pages describe templates, automated replenishment, and configurable business rules that match "your operational processes." (SOM; SNM.) No public IQ/OQ for a packaging line exists in the sources, so validation stays with the customer.

9. Customer evidence

Account	What is public	Limit
Named customers	None on the SNM or SOM pages. Testimonial sections are headings with no quote.	No public case study cited.
Network, 27 Feb 2026	Counts in section 7.	Company release.
DSCSA 2025	The release says the network executed the dispenser milestone.	No FDA record. No named dispenser.

10. Competitive and third-party context

The about page says TraceLink is active in GS1, BSMA, HDA, and the Partnership for DSCSA Governance and has been "recognized by IDC, Gartner, and Healthcare Innovation," with no report title or year. Membership is a company statement, not an endorsement of the software. The February 2026 release is a company wire, not an independent evaluation.

11. Changes and renames

• 2003–2009: SupplyScape, ePedigree application, rename to TraceLink (section 2).
• 2017–2021: Integrate-Once.
• 2022–2024: MINT, POET, and track-and-trace share an OPUS metadata model.
• 2025–present: agentic operating system language.
• 27 February 2026: company release on DSCSA and OPUS, datelined Boston.

SNM and SOM are current products on TraceLink's site.

12. Source library

Full URL list: ../sources/tracelink-serialization-sources.md.

Claim-level records: ../evidence/tracelink-serialization.evidence.jsonl.

Primary pages:

• https://www.tracelink.com/products/product-orchestration/serialization
• https://www.tracelink.com/products/product-orchestration/serialization/serial-number-manager
• https://www.tracelink.com/products/product-orchestration/serialization/serialized-operations-manager
• https://www.tracelink.com/about
• https://www.tracelink.com/legal-and-trust/website-terms-of-use
• https://www.prnewswire.com/news-releases/tracelink-builds-on-transformative-2025-to-scale-agentic-orchestration-across-the-global-life-sciences-supply-chain-in-2026-302699828.html