Product: NuGenesis Scientific Data Management System (SDMS), the automated data-repository component of Waters NuGenesis Software. The same suite includes NuGenesis Lab Management System (LMS), which Waters calls a flexible analytical electronic laboratory notebook, NuGenesis Sample Management, and a stability solution. Those are not this profile. Empower CDS is a separate chromatography system that SDMS can archive. Vendor: Waters. U.S. award records name two recipients: Waters Corporation (UEI ERVJKCK3HZA6) and Waters Technologies Corporation (UEI JFT8BGF7FKV6). Waters Associates opened in Framingham in 1958 and listed on the NYSE in 1995. A 2026 history line says Waters combines with BD Biosciences and Diagnostic Solutions, with no statement on NuGenesis. Category: Scientific data management system (SDMS): capture, catalog, archive, search, and restore of instrument and document data. Adjacent, not a LIMS. The suite URL title says "LIMS Workflow," but SDMS sends data to a LIMS rather than acting as one. Verification date: 2026-10-03. Scope: Public sources only.

1. Overview

NuGenesis SDMS is Waters' scientific data management system: it captures, catalogs, and archives instrument output, including Empower CDS chromatography data, and is the repository under the NuGenesis LMS analytical ELN. It is adjacent rather than a LIMS because it stores and retrieves lab data and hands selected results to a LIMS or ERP, and Waters sells it to pharmaceutical, biotechnology, and environmental labs that must retain data under GLP, GxP, cGMP, and 21 CFR Part 11.

Waters calls NuGenesis SDMS an automated data repository and "the foundation of the NuGenesis Lab Management System (LMS)." It imports data from instruments, scientists, and outside sources into a central repository for search, review, and sharing, and Waters says it helps meet GLP, GxP, cGMP, 21 CFR Part 11, Sarbanes-Oxley, and EPA CROMERRR. (SDMS page, retrieved 2026-10-03.)

The SDMS page claims "hundreds of companies" and names pharmaceuticals, biotechnology, and environmental science. The releases overview repeats a boilerplate recommended-use line for pharmaceutical, chemical, food and beverage, and environmental companies.

SDMS captures and archives printouts, raw spectra and chromatograms, documents, Windows and UNIX content, and vendor-neutral formats including IUPAC JCAMP-DX. It extracts metadata, searches, restores files to the original application, and supports electronic signatures, annotations, long-term retention, retirement, and legal hold. It includes a viewer called InSpector and connectors, with SAP as the named example.

Boundaries:

• Not NuGenesis LMS. LMS works on information already in the SDMS repository for R&D and process-driven QC workflows. Sample submission, stability, and inventories are suite-level functions. (Suite page.)
• Not a LIMS. The SDMS page lists "LIMS, or ERP" as software that can receive selected data, next to Microsoft Office and NuGenesis LMS.
• Not Empower CDS. The suite page archives and searches Empower CDS data in SDMS. One later sentence on that page, "Integrating Empower Scientific Data Management System (SDMS)," swaps the names; the earlier paragraphs keep them apart.
• Not an MES or a QMS.
• Current product. The support overview lists 2024 and 2025 NuGenesis releases in mainstream support, with SDMS changes inside them. NuGenesis 8 SR2 is obsolete (May 2016).

2. Company and product identity

Point	Fact	Source
Brand and history	Waters Associates, Framingham, 1958. Millipore era, management-led split, IPO and NYSE listing in 1995. 1992 Millennium software, rebranded Empower in 2002. NuGenesis is not on that list.	About Waters
2026 corporate line	"Waters Combines with BD Biosciences and Diagnostic Solutions Businesses." No price, closing date, or NuGenesis statement.	About page
Contracting names	Waters Corporation, UEI ERVJKCK3HZA6, on 2008 and 2019 purchase orders. Waters Technologies Corporation, UEI JFT8BGF7FKV6, on a 2020 delivery order.	USAspending awards, section 7
SDMS versus LMS	SDMS is the repository and the foundation of LMS. The suite has three names: SDMS, LMS, Sample Management. A 9.0 release note says "LMS base kit (SDMS)" and "LMS Option kit."	SDMS page; suite page; releases overview
Current releases	NuGenesis LMS 9.3.2 (July 2024), 9.4.0 and 9.4.1 (January 2025), all mainstream support. 9.4.1 SDMS lines: SEC-MALS from Empower, audit-trail database and query work, and disabling SDMS users when the Active Directory account is disabled.	Releases overview (dates are those printed nearest each version heading)
Oracle	9.0.2 (October 2020, limited support): schema tested on Oracle 19c (19.6) on Linux Red Hat 7.7 with the customer's own Oracle license; Windows servers on the Waters embedded license get Oracle 12.2.	Same overview

3. Pharma and regulated-lab relevance

• Compliance claims. Waters says SDMS "helps manage data to meet" GLP, GxP, cGMP, 21 CFR Part 11, Sarbanes-Oxley, and EPA CROMERRR. Vendor language, not an FDA or EPA clearance. (SDMS page.)
• Retention and legal hold are SDMS functions. A 2015 row for an obsolete NuGenesis 8 feature release also lists data retention, legal hold, and Annex 11 compliance readiness; it does not describe 9.4. (SDMS page; releases overview.)
• QC and stability are suite functions (process-driven QC workflows, stability protocol management). SDMS connectors move test requests, SOPs, specifications, and results so labs can "more quickly release in-spec products." That is a documentation bridge, not MES batch release. (Suite page; SDMS page.)
• Empower archive. Administrators can automatically archive and search Empower CDS data in SDMS. Release notes through 9.4.1 continue Empower adapter work, including empty-project archive and SEC-MALS. (Suite page; releases overview.)

4. Capabilities

Capability	Status	Fact	Source
Automatic capture	SDMS page	Import after creation or change: print data, raw spectra and chromatograms, documents, Windows and UNIX content, JCAMP-DX.	SDMS page
Catalog and search	SDMS page	Metadata extracted at capture; search across servers, projects, and data types; text search in reports, graphs, tables, charts.	SDMS page
Viewing	SDMS page	Several formats; restore to the original application. InSpector views NMR, MS, LC-MS, IR, UV/Vis, fluorescence, chromatography, and structures.	SDMS page
Signatures and annotations	SDMS page	Electronic signatures, annotations, attached files.	SDMS page
Retention and legal hold	SDMS page	Long-term retention, retirement, legal hold.	SDMS page
Send onward	SDMS page	Selected data to NuGenesis LMS, Microsoft Office, LIMS, or ERP, with hyperlinks back to source data.	SDMS page
Connectors	SDMS page	Bidirectional link between instruments and business applications "like SAP": test requests, SOPs, specifications, results.	SDMS page
Empower archive	Suite page; release notes	Automatic archive and search of Empower CDS; adapter and SEC-MALS work in later notes.	Suite page; releases overview
Audit trail viewer	Release notes	9.1: SDMS Audit Trail Viewer in Chrome. 9.3: Web Vision runs on Edge or Chrome instead of Internet Explorer; audit trail segmented into categories.	Releases overview
Sample management and stability	Other NuGenesis products	Suite-level, not SDMS.	Suite page
Database	Release note	9.0.2: Oracle 19c tested; embedded Windows license on Oracle 12.2.	Releases overview

5. Architecture and deployment

Waters says SDMS "scales from a single laboratory to a global enterprise without major modifications to your existing IT infrastructure." The marketing page names no cloud, SaaS, or region. (SDMS page.)

The release notes describe on-premises software: Windows clients and servers, a file-capture server, Oracle databases, Linux install scripts, a Waters Database Manager for backups, and a choice between a customer-owned and a Waters embedded Oracle license. Versions 9.3.2, 9.4.0, and 9.4.1 name Windows Server 2022 and Windows 11 clients. 9.3 dropped the Internet Explorer requirement for SDMS Web Vision, a client change, not a cloud move. (Releases overview.)

Not published: a Waters-hosted SDMS cloud, uptime SLA, RPO/RTO, or a security white paper.

6. Integrations

Kind	Fact	Weight
SDMS connectors	Configurable bidirectional utilities, with SAP as the example for test requests, SOPs, specifications, and results.	One named business system. Not an SAP certification.
LIMS, ERP, ELNs	SDMS "works both independently or in conjunction with" those classes, plus analytics and visualization programs.	Category sentence. Only SAP and Microsoft Office are named.
Empower CDS	Archive, search, instrument sync into LMS inventory, Fit For Use status, SEC-MALS into SDMS. Empower 3.10.0 is named on the 9.4.1 heading.	Deepest named integration. Version-specific.
SDK	LMS SDMS SDK and section attachments on older and 9.1/9.3 rows.	Developer hook.
Active Directory	9.4.1 disables SDMS users when the AD account is disabled.	One identity behavior, not a full SSO specification.

7. Pricing and commercial model

Price: quote-only. Waters publishes no SDMS price. The releases page directs customers to a local Waters representative for versions and upgrades. Third-party NuGenesis 8 kit prices are not used; version 8 is obsolete.

Public money that is not a list price

Three HHS awards on USAspending mention NuGenesis. All are firm fixed price, NAICS 334516 (Analytical Laboratory Instrument Manufacturing).

Award	Recipient	Description	Obligation	Signed	Period	Place	PSC	Parent
HHSF222200813088P	Waters Corporation, UEI ERVJKCK3HZA6	NuGenesis software support and license	USD 13,018.14	2008-09-03	2008-09-03 to 2008-09-05	St. Louis, MO	3590	none
75F40119P10509	Waters Corporation, same UEI	NuGenesis LMS named user (6)	USD 9,335.29	2019-08-20	2019-08-20 to 2020-08-20	San Juan, PR	H266	none
75F40120F80300	Waters Technologies Corporation, UEI JFT8BGF7FKV6	NuGenesis LMS named user licenses and maintenance	USD 10,805.55	2020-07-09	2020-07-09 to 2021-07-08	San Juan, PR	7030	GSA schedule GS07F0559X

The 2019 and 2020 buyer is FDA Office of Acquisitions and Grants Services; the 2008 record says Department of HHS / Food and Drug Administration.

• Waters Corporation and Waters Technologies Corporation are separate recipients with separate UEIs.
• Two descriptions say LMS, and the 2008 line says "NuGenesis software." None is an SDMS unit price. The "(6)" on the 2019 line does not show that the $9,335.29 covers only six licenses, so it does not yield a per-user price.
• The 2020 order ran against GSA schedule GS07F0559X.

SAM.gov notices. Three notices name NuGenesis. None prints a price, and none is an award.

Notice	Buyer and seller	Product	Price
RFQ-RT-02-00370, presolicitation, 2002-07-15. API	U.S. EPA, RTP Procurement Operations Division, Research Triangle Park, NC (contact Pamela E. Smith). Intended seller: NuGenesis Technology Corp., 1900 West Park Drive, Westborough, MA 01581. Sole source, FAR 6.302-1.	"UNIFY & NuGenesis VISION Software Licenses, E-Signature Option, Extraction Templates Software, Implementation and/or Training services and NuGenesis UNIFY & Vision Software Yearly Maintenance for 1 Year." No SDMS.	None; no RFQ or attachment.
RFQ-RT-04-00260, presolicitation, 2004-04-20. API	Same EPA office and intended seller.	Title misspells "Mannagement." Body: "Nugenesis Scientific Data Management System Maintenance, Support and Upgrade services fees for: Server Software; Print-Vision Software Named Users: Template Builder Software; Extraction Template Builder Software & e-Signature." SDMS maintenance bundled with other tools.	None; no RFQ or attachment.
FDA-19-RFQ-1217373, combined synopsis/solicitation, 2019-07-19. API. Attachment FBO_-_RFQ1217373_NuGenesis_LMS.docx.	FDA San Juan Laboratory, 466 Fernandez Juncos Ave., San Juan, Puerto Rico 00901. Contract specialist Todd J. Johnston; contracting officer Gary Klaff.	"NuGenesis LMS." The lab already uses "NuGenesis ELN/SDMS." CLIN 1 "NuGenesis LMS Named User," quantity 6; CLIN 2 "Maintenance Service-NuGenesis LMS Named User," quantity 6; "MAINT-NuGenesis 8 LMS Named User (6)." Each license "provides SDMS viewing, retrieval, print capture, ELN and LE capabilities" on up to five SDMS and five ELN databases for one named user.	Blank price cells. Firm-fixed-price order intended.

NuGenesis Technology Corp. of Westborough, the 2002 and 2004 seller, is a different name from the two Waters entities on the later awards.

Two other SAM.gov results ("Citrix Server Upgrade," "66 -- HIGH THROUGHPUT SAMPLER") do not mention NuGenesis. EU TED on 3 Oct 2026: no NuGenesis notices. UK Contracts Finder's keyword filter returned only unrelated notices, so no UK result is reported.

Questions a buyer should ask

1. Is the quote the SDMS base kit, the LMS option, sample management, stability, or a bundle? Ask the seller to map the release notes' "base kit (SDMS)" to 2026 terms.
2. Named user, server, instrument, or site? The 2019 FDA line says named user without a definition.
3. Whose Oracle license, and is the embedded database still Oracle 12.2 on Windows?
4. Which Empower version does the adapter support, and is SEC-MALS in the base SDMS price?
5. Are SAP connectors included?
6. What is the support status of the version being sold, in Waters' mainstream, limited, and obsolete terms?
7. Is there a cloud offer, or only on-premises?
8. Which legal entity invoices, Waters Corporation or Waters Technologies Corporation?
9. If the buy is against GS07F0559X, which current schedule line applies?
10. Which validation deliverables ship with SDMS file-capture templates, and which must the lab author?

8. Implementation and validation support

The releases page describes bundle installers, Waters Database Manager backups, and file-capture templates, and sends customers to a Waters representative for versions and upgrades. Waters publishes no validation protocol, IQ/OQ, or implementation timeline for SDMS.

9.3 notes say a single login and privileges control feature access. 9.3.2 and 9.4 notes cite security enhancements and a more detailed audit trail. These are change notes, not a 21 CFR Part 11 assessment. Waters help links user manuals, including a 9.4.0 SDMS data-adapter guide.

9. Customer evidence

Waters publishes no named SDMS case study. "Hundreds of companies" has no method behind it. The about page's customer quotes cover waters_connect, TA Instruments, and service, not NuGenesis.

Procurement is the public customer evidence:

• FDA-related HHS offices bought NuGenesis support or LMS named-user licenses in 2008, 2019, and 2020 from two Waters entities, for St. Louis and San Juan. Purchase evidence, not outcomes, and for the LMS lines not an SDMS-only deployment.
• EPA Research Triangle Park posted sole-source intents in 2002 (UNIFY and VISION) and 2004 (SDMS maintenance plus Print-Vision and template tools) to NuGenesis Technology Corp.
• The 2019 San Juan RFQ covers six NuGenesis 8 LMS named users at a lab already running ELN/SDMS.

10. Competitive and third-party context

No public analyst report covers NuGenesis SDMS. The about page's awards and the 2026 BD combination are company facts, not SDMS capabilities.

11. Changes and renames

• 1958 and 1995: Waters founding and NYSE listing.
• May 2016: NuGenesis 8 SR2 obsolete. SDMS-Empower integration is in that release's benefit list.
• October 2020: 9.0.2, Oracle 19c versus embedded Oracle 12.2.
• July 2024: 9.3.2, mainstream support.
• January 2025: 9.4.0 and 9.4.1, mainstream support, with SDMS audit-trail and Empower adapter changes.
• 2026: combination with BD Biosciences and Diagnostic Solutions; no NuGenesis effect stated.

NuGenesis SDMS remains a current product. Version 8 is the obsolete line.

12. Source library

Full URL list: ../sources/waters-nugenesis-sdms-sources.md.

Claim-level records: ../evidence/waters-nugenesis-sdms.evidence.jsonl.

Primary pages:

• https://www.waters.com/nextgen/us/en/products/informatics-and-software/lms-and-data-management/nugenesis-software/nugenesis-sdms.html
• https://www.waters.com/nextgen/us/en/products/informatics-and-software/lms-and-data-management/nugenesis-software.html
• https://help.waters.com/help/en/product-support/nugenesis-software-support-solutions/nugenesis-software-releases-overview.html
• https://www.waters.com/nextgen/us/en/about-waters.html
• https://www.usaspending.gov/award/CONT_AWD_75F40120F80300_7524_GS07F0559X_4732
• https://www.usaspending.gov/award/CONT_AWD_75F40119P10509_7524_-NONE-_-NONE-
• https://www.usaspending.gov/award/CONT_AWD_HHSF222200813088P_7524_-NONE-_-NONE-