Product: Thermo Scientific SampleManager LIMS Software, version 21.3, catalog INF-11000. Vendor: Thermo Fisher Scientific (brand Thermo Scientific). U.S. federal contracting entity: Thermo Lab Systems Inc. Category: Laboratory information management system (LIMS) for process-development and manufacturing QA/QC labs, with built-in LES, SDMS, and ELN functions. Not an MES, ERP, CDS, Watson LIMS, or Core LIMS. Verification date: 2026-10-03. Scope: Public web sources only.

1. Overview

SampleManager LIMS is Thermo Fisher's manufacturing and process-development LIMS, with LES, SDMS, and a notebook built in and a direct link to Chromeleon CDS. It sells to pharma, CDMO, food, petrochemical, water, and contract-testing QC labs, and Thermo Fisher runs it across its own Pharma Services network, including Patheon.

Thermo Fisher calls SampleManager a complete informatics solution for lab, data, process, and compliance management, supporting process development and manufacturing QA/QC. (Product page.) Its target industries are pharmaceutical, food and beverage, oil and gas, petrochemical, water and environmental, manufacturing, and contract testing, from a single lab to multi-site. (Catalog INF-11000.) The catalog calls it "the world's most widely deployed LIMS." The LIMS family page adds pharma and biopharma (small molecules, peptides, CAR-T) without naming SampleManager. (industries page.)

The LIMS registers samples, schedules tests, checks results against specification limits, logs OOS and OOT incidents, generates CoA PDFs, manages stocks and instruments, signs records, and connects to instruments and enterprise systems.

Thermo Fisher's portfolio around it:

• LES: step-by-step SOP and method execution with procedural history, which the catalog also calls "procedural ELN."
• SDMS: raw data and metadata secured across the data lifecycle, independent of the original instrument software.
• Built-in ELN: rich text, spreadsheets, PDFs, molecular structures. Labguru is Thermo Fisher's separate "chosen" ELN and integrates with Thermo Scientific LIMS. (ELN page.)
• Chromeleon CDS, linked through the SampleManager–Chromeleon Link.
• Integration Manager, a separate integration bus for complex connections.
• Watson LIMS (bioanalysis) and Core LIMS (R&D, NGS, biobanking) are separate LIMS products.
• MES and ERP are external systems. The software is for general laboratory use, not diagnostic procedures.

Version 21.3 is current.

2. Company and product identity

Point	Fact	Source
Product name	Thermo Scientific SampleManager LIMS Software.	Product page
Catalog	INF-11000, "SampleManager LIMS," unit size "Each."	INF-11000
Current release	"SampleManager LIMS Software 21.3," undated. Earlier documents: a 21.2 flyer and "SampleManager software 21.0 Validation approach."	21.3 page
Track record	"Over three decades of experience."	21.3 page
Portfolio split	R&D: Core LIMS. Process development and manufacturing: SampleManager LIMS, SDMS, and LES. Bioanalysis: Watson LIMS.	Resources
U.S. contracting entity	THERMO LAB SYSTEMS INC, UEI MR9NR31M4MZ7. Parent on 2022 and 2023 awards: THERMO ELECTRON CORPORATION, 1601 Cherry St, Philadelphia, PA 19102. Parent on the 2026 award: THERMO FISHER SCIENTIFIC INC, 300 Industry Dr, Pittsburgh, PA 15275.	USAspending (section 7)
Quality system	Developed under an ISO 9001 certified quality system.	Product page FAQ; 21.3 page

3. Pharma and biotech relevance

Thermo Fisher positions SampleManager for process development and manufacturing QA/QC, and lists pharmaceutical labs among its core industries.

Compliance claims. SampleManager is designed to support ALCOA++ and can be configured for GMP, ISO 17025, and 21 CFR Part 11. Configurations support EudraLex Volume IV Annex 11 and Part 11, with a username-and-password signing ceremony stored with date and time. Thermo Fisher publishes "SampleManager 21 CFR 11 Compliance Guidelines 2023" for customers. Incident management investigates OOS and OOT results and links each incident to the sample, test, or result. (FAQ.)

Patheon, Cork. Thermo Fisher's Patheon pharma services lab in Cork replaced its informatics with SampleManager in the cloud, implemented largely remotely from the start of the COVID-19 pandemic. Phase one covered multi-level parameters, workflows, a CDS interface, and CoA; stability, LES, consumables management, and a simple instrument interface followed. A site LIMS specialist reports lower testing backlog and cycle times. (Connected Lab, John McDonald, 19 April 2023: Patheon post.)

Thermo Fisher Pharma Services. Pharma Services made SampleManager the digital backbone of its "Pharma 4.0" program across a network of 55+ sites. Bill Weiser, Tanya Tadey, and Saly Romero-Torres describe planned customer-facing CoA, stability reports, and analytics. (22 September 2021: Pharma Services post.)

Anti-doping. Université Paris-Saclay has a maintenance framework for the LIMS SampleManager package at the French anti-doping laboratory (LADF) (section 7).

FDA and EMA search pages could not be queried on 3 Oct 2026, so no FDA or EMA record naming SampleManager is cited.

4. Capabilities

Capability	Type	What Thermo Fisher documents	Source
Sample registration and test schedules	Native	Workflows, manual login, manifests, schedules that assign tests; results checked against multiple specification limits.	Catalog FAQ
CoA	Native	Version-controlled templates exported as PDF, manually or automatically.	Catalog FAQ
OOS / OOT incidents	Native	Incident records linked to sample, test, or result.	Catalog FAQ
Review and approval	Native	Inspection plans run round-robin (parallel) or linear (sequential); authorization with electronic signature; authorized data read-only.	Catalog FAQ
Audit trail	Native	Old and new values, user, time, and reason; prompted audits require a reason.	Catalog FAQ
Electronic signatures	Native	Username-and-password signing ceremony linked to the record with date and time.	Catalog FAQ
Stocks and reagents	Native	Low-stock and expiry alerts, optional block on expired stock, lot, location, consumption.	Catalog FAQ
Instruments, calibration, AQC	Native	Logbooks, calibration schedules, statistical charts; AQC per ASTM D6299 (product page cites ASTM D6299-23a).	Catalog FAQ; 21.3 page; product page
LES	Built-in LES	Step-by-step SOP and method guidance with procedural history; also used for destruction procedures.	Product page; catalog; FAQ
SDMS	Built-in SDMS	Raw data and metadata secured through the lifecycle, independent of instrument software.	Product page
Notebook	Built-in ELN	Rich text, spreadsheets, PDFs, molecular structures.	Product page
Labguru ELN	Separate product	Thermo Fisher's "chosen" ELN; integrates with Thermo Scientific LIMS.	ELN page
File sweeper	Included tool	Background or interactive import of instrument files, including PDFs and binaries (21.3); simple instruments post directly to the result field.	21.3 page; FAQ
Integration Manager	Separate product	XML integration bus with distributed agents for complex instrument and enterprise links.	Catalog FAQ; training course
Chromeleon Link	Link to separate CDS	Unifies chromatography data between SampleManager and Chromeleon.	21.3 page; product page
SAP QM	Native interface (21.3)	SMIDI "now supports SAP remote function calls" to SAP QM and other SAP systems.	21.3 page
MES, ERP, PIMS, CDS	Connectivity	Named connection targets.	Product page; implementation page; catalog
Contract portal	Native	External users review quotes, log samples, print labels, see invoices and results.	Product page; UX page
Clients	Native	Desktop, web client, and a native mobile app on tablet; barcode scanning and voice commands configurable.	UX page
Analytics	Packages	AI "Autonomous Test Revisor" for review by exception, a predictive AI solution, and preconfigured BI dashboards.	Analytics page
Identity	Native	Native passwords, Active Directory / LDAP, SSO via OAuth 2.0 or OpenID Connect (Okta named; not SAML); MFA through the IdP.	Catalog FAQ
Labels	Native	Label designer with GHS symbols and barcodes.	Catalog FAQ
Environments	Native	Development, test, and production with change-promotion tools; training environments on request.	Catalog FAQ
Biorepository dashboard	Native	A "Biorepository solution" dashboard (separate from Core LIMS).	FAQ

The related-products page also names a Connect Platform; Thermo Fisher publishes no specification for it. The generic LIMS features page does not mention SampleManager.

5. Architecture and deployment

Three deployment models: cloud managed by Thermo Fisher on AWS, cloud managed by the customer, and on-premises. The Thermo Fisher-hosted option carries an annual hosting fee "calculated based on the number of licenses."

Version 21.3 runs on Microsoft .NET, exposes a REST API with token authentication and "hardened session handling," and adds SMIDI for SAP remote function calls.

Thermo Fisher-hosted cloud controls (catalog FAQ): encryption in motion and at rest; auto-recovery; intrusion detection; login monitoring; a "24-hour recovery time objective and point objective." The detailed answer names S3, FSx for Windows, and RDS for Oracle; AES-256 at rest; TLS 1.2 or IPsec VPN in transit; keys in AWS KMS; daily backups with point-in-time recovery; backups in S3 across availability zones; and annual restoration tests. Encryption on on-premises and customer-hosted installs is the customer's job.

The database uses active and committed schemas plus an archival database. Support runs "follow the sun," with a stated 4-business-hour response target and 24/7 cover for critical errors.

Thermo Fisher publishes no security white paper, data-residency list, or browser matrix.

6. Integrations

Interface	What Thermo Fisher documents
File sweeper (included)	Maps instrument files, including complex PDFs and binaries, into SampleManager through a WCF service.
Simple instruments	A balance on a client PC can write a value straight into the result field.
Integration Manager (separate)	XML bus and agents for instruments and enterprise applications. Thermo Fisher runs a 3-day course on it; next session 3 Nov 2026, virtual Americas.
Chromeleon CDS	SampleManager–Chromeleon Link.
SAP	SMIDI with SAP remote function calls to SAP QM and other SAP systems.
MES, ERP, PIMS	Named connection targets.
Maintenance systems	Calibration schedules can come from external maintenance software such as Maximo, or from SampleManager's own instrument records.
Identity	Active Directory, LDAP, OAuth 2.0 / OpenID Connect.
Analytics	Built-in BI; implementation projects connect Power BI, Tableau, and R-Shiny.
Labguru ELN	Integrates "with existing workflows and procedures in Thermo Scientific LIMS software."

No public API reference exists.

7. Pricing and commercial model

Pricing is quote-only. Catalog INF-11000 reads "Price (USD) - Request A Quote." Thermo Fisher publishes no per-user, per-site, or perpetual fee. The hosted AWS option adds an annual fee based on license count. Implementation, training, and validation are professional services under a statement of work. LES, report designer, and instrument integration are separate training topics.

Public contract records

All three are firm-fixed-price purchase orders to Thermo Lab Systems Inc., not competed, one offer each, PSC 7A21 (business application software, perpetual license).

Order	Buyer	Signed	Description	Obligated (USD)	Period	Place
N3904023P0007	Department of the Navy, Portsmouth Naval Shipyard GF	2022-10-26	"SAMPLEMANAGER SW SUPPORT"	11,966.71	2022-10-30 to 2023-02-27	Philadelphia, PA 19102
N3904023P0075	Same office	2023-03-02	"THERMOFISHER SAMPLEMANAGER LICENSES"	131,771.72	2023-03-02	Philadelphia, PA 19102
HC102826P0011	Defense Information Systems Agency, IT Contracting Division	2026-03-09	"SAMPLEMANAGER SOFTWARE SUPPORT RENEWAL"	150,072.93	2026-03-09	Norfolk, VA 23513

In Europe, Université Paris-Saclay published TED notice 768332-2025 (19 November 2025) for a framework for third-party application maintenance of the LIMS SampleManager package at the Laboratoire antidopage français (LADF). No value is published.

Questions a buyer should ask

1. What does INF-11000 "Each" include, and is the license named-user, concurrent, site, or instrument-based?
2. Which of LES, SDMS, the built-in notebook, Labguru, Chromeleon, Integration Manager, and the ATR/AI/BI packages are in the software price?
3. Perpetual, subscription, or AWS-hosted? Federal orders classify even support renewals as perpetual license software.
4. Which environments (development, test, production) are included?
5. Which database does on-premises run? Oracle RDS is named only for the hosted store.
6. Is the 2023 Part 11 compliance guideline delivered with the quote?
7. What is the support lifecycle per version? CSols reports version 10 went off support before a move to version 21.
8. Are IQ, OQ, and PQ scripts in the quote? CSols reports one upgrade purchase order omitted them.
9. On hosted AWS: data residency, backup, GxP process owner, and which RTO/RPO is contractual?
10. SAP, MES, and CDS: SMIDI and Chromeleon Link, Integration Manager, or project services?

8. Implementation and validation support

Thermo Fisher staffs projects with a PMP- and PRINCE2-certified project manager, a lead consultant, a system architect, and LIMS analysts through initiation, delivery, and completion. Thermo Fisher says cloud services simplify SampleManager deployment. No durations or GAMP category are published. (Implementation.)

From the catalog FAQ:

• Services follow the provider's methodology under an ISO-accredited QMS, starting with a project-initiation meeting on schedule, resources, risks, deliverables, and acceptance.
• Training covers standard product or the customer's configuration, train-the-trainer style: data configuration, administration, report designer, workflow designer, LES, and instrument integration.
• A test environment runs scripts traced to requirements.
• Audit scope is set during implementation to keep unused fields out of the audit table.

Validation documents: "SampleManager software 21.0 Validation approach" (brochure) and "SampleManager 21 CFR 11 Compliance Guidelines 2023."

CSols reports on an unnamed midsize pharmaceutical CDMO that moved from SampleManager version 10, off support, to version 21 for new functionality. A planned six-month upgrade ran for years after the original implementer was acquired and staff turned over, and the original purchase order lacked test scripts, which led to CAPAs and deviations. (CSols.)

9. Customer evidence

Account	Evidence	Limit
Patheon pharma services, Cork	Thermo Fisher blog, 19 April 2023: cloud SampleManager replaced older systems; CDS interface, CoA, stability, LES; lower backlog and cycle time. A video on Patheon scientists is also listed.	Thermo Fisher's own business. Specialist unnamed.
Thermo Fisher Pharma Services	Blog, 22 September 2021: SampleManager across a 55+ site network; quotes from Bill Weiser, Tanya Tadey, Saly Romero-Torres.	Own business; quotes mostly forward-looking.
Midsize pharmaceutical CDMO	CSols: version 10 to 21, multi-year upgrade, missing validation scripts.	Customer unnamed.
Université Paris-Saclay / LADF	Maintenance framework for SampleManager at the French anti-doping lab.	No value.
U.S. Navy and DISA	License and support orders to Thermo Lab Systems Inc.	Procurement.

10. Competitive and third-party context

Thermo Fisher markets SampleManager as "one application" and "the only LIMS" for the listed needs, while also selling Watson LIMS and Core LIMS. No Gartner, Forrester, or IDC placement is cited. CSols, a services firm that also works on LabWare, is the main third-party project account.

11. Changes and renames

• SampleManager has "over three decades" of history; the name is unchanged.
• Version 21.3 (undated) adds SMIDI SAP remote function calls, sweeper changes, resource tasks, Chromeleon Link, .NET and REST security hardening, and AQC changes tied to ASTM D6299.
• Version 10 is off support, per CSols.
• 2021-09-22: Pharma Services rollout published.
• 2022-10-26 and 2023-03-02: Navy support and license orders (parent Thermo Electron Corporation).
• 2023-04-19: Patheon Cork case published.
• 2025-11-19: Université Paris-Saclay maintenance framework.
• 2026-03-09: DISA support renewal (parent Thermo Fisher Scientific Inc., Pittsburgh).

12. Source library

Pages retrieved 2026-10-03. Full URL list: sources note. Every claim above is in the product's evidence set with its source, type, and confidence.

Primary pages:

• https://www.thermofisher.com/us/en/home/digital-solutions/lab-informatics/lab-information-management-systems-lims/solutions/samplemanager.html
• https://www.thermofisher.com/us/en/home/digital-solutions/lab-informatics/lab-information-management-systems-lims/solutions/samplemanager/latest-version.html
• https://www.thermofisher.com/us/en/home/digital-solutions/lab-informatics/lab-information-management-systems-lims/solutions/samplemanager/data-analytics.html
• https://www.thermofisher.com/us/en/home/digital-solutions/lab-informatics/lab-information-management-systems-lims/solutions/samplemanager/ux.html
• https://www.thermofisher.com/order/catalog/product/INF-11000
• https://www.thermofisher.com/order/catalog/product/INF-11000/faqs
• https://www.thermofisher.com/us/en/home/digital-solutions/lab-informatics/lab-information-management-systems-lims/resources.html
• https://www.thermofisher.com/blog/connectedlab/driving-productivity-and-efficiency-with-lims-software-at-a-global-pharmaceutical-cdmo/
• https://www.usaspending.gov/award/CONT_AWD_N3904023P0075_9700_-NONE-_-NONE-
• https://www.usaspending.gov/award/CONT_AWD_N3904023P0007_9700_-NONE-_-NONE-
• https://www.usaspending.gov/award/CONT_AWD_HC102826P0011_9700_-NONE-_-NONE-