Seal vs Waters NuGenesis

1Waters NuGenesis and Seal, side by side.

NuGenesis and Seal both keep original instrument data with audit trails and electronic signatures. They differ in what the data is organised around. Waters describes NuGenesis SDMS as an automated repository that imports data from instruments, scientists and outside sources into a central catalogue, and NuGenesis LMS as that repository combined with an analytical notebook and sample management, from discovery through manufacturing.¹² In Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, so each acquisition is a record linked to the sample, batch and investigation it supports.

2What Waters NuGenesis is built for.

NuGenesis is designed for laboratories that want one compliance-ready repository for data from many instruments and applications, with notebook and sample workflows on top. It comes from Waters Corporation, which also makes the Empower chromatography data system, and Waters recommends it for pharmaceutical, chemical materials, food and beverage, and environmental companies.² Waters says that combining Empower with NuGenesis SDMS lets a laboratory manage its analytical data in one compliance-ready repository.³

NuGenesis SDMS captures, indexes and stores data as soon as it is created or changed. It manages printed data, including the content of instrument-generated reports; raw instrument data such as spectra and chromatograms; documents and reports from scientific and business applications; and data converted to vendor-neutral formats such as IUPAC JCAMP-DX, with long-term retention, retirement and legal hold.¹ It scans servers, projects and data types for new content, extracts metadata during capture and creates a catalogue for search. Users can view data without the source application in Waters’ InSpector viewer, which covers techniques such as NMR, MS, LC-MS, IR, UV/Vis and chromatography; apply electronic signatures and annotations; and restore instrument data to its original application for further analysis.¹

NuGenesis LMS adds an analytical electronic lab notebook, NuGenesis Sample Management, which identifies out-of-specification results and produces reports for review and approval, and a Stability module that Waters says can run stability operations without a LIMS. Out-of-the-box templates cover instrument, reagent, column and sample management. Waters describes the system as compliance-ready for 21 CFR Part 11, with time stamping, configurable electronic signatures and workflow, and version control with full audit trails.²

NuGenesis LMS 9.4.0, the latest release with notes listed on Waters’ product page, is a feature release for existing customers. Waters tested it with an Oracle 19c production database on Windows Server or Red Hat Enterprise Linux, application servers on Windows Server 2019 or 2022, and Windows 10 and 11 clients.⁴

3How an instrument file reaches its result.

Both products keep the original file. What differs is what the file is attached to when it arrives.

In NuGenesis, capture is organised around sources: file-capture and print-capture projects, SDMS instrument agents, and templates that define what is captured and archived.⁴ The catalogue then lets scientists find, view and reuse the data, and send selected text, tables or graphics to the notebook, a LIMS, an ERP or Microsoft Office, with hyperlinks back to the source data.¹ NuGenesis Connectors provide a bidirectional link with business systems such as SAP for test requests, SOPs, product specifications and test results.¹

In Seal, Seal IoT watches a chosen folder on the instrument workstation, waits for each file to stop changing and uploads supported exports over outbound HTTPS to a configured Seal record. In the example in Seal’s SDMS blueprint, acquisition ACQ-1842 keeps its five original files and links to sample QC-1842, batch B-041 and investigation DEV-018, so a reviewer, an investigator and Neil reach the same preserved original from the work they are doing.

The capture rule defines the files a chromatographic run should produce, such as raw data, method, sequence, audit trail and report. ACQ-1842 has its report but not its audit trail, so it stays incomplete: a finished PDF does not prove that the rest arrived. Reprocessing creates a derived record. Report v02 reprocesses the same original as v01, which stays available, and the input objects, method, software version, changed parameters and reason are kept together, so a reviewer can compare the two results and reach the same acquisition from either.

4How a capture change is controlled.

Both vendors treat a change to the data system as a change-control matter. In Seal, the capture configuration is itself a versioned record that carries its verification.

Waters’ release notes for NuGenesis LMS 9.4.0 recommend that any installation, change or removal of software in a regulated environment follows the organisation’s approved change control procedure. They ask customers to assess the impact on the system’s qualification status and validation for its intended use, including personnel, methods, laboratory workflows and connected equipment. The release media include an AutoIQ folder alongside the installers.⁴

In Seal, a software upgrade that changes an export format, a new method that adds a companion file or a parser update that changes an extracted value is a controlled configuration change. In the SDMS blueprint, a new instrument software version becomes capture rule v09, proposed with its checks, while ACQ-1842 keeps v08, the configuration it was captured under. The change covers the agent version, trigger script, source path, destination template and metadata mappings, with the relevant requirements, specifications and verification linked to it. Neil can assemble these in a changeset with the revised configuration and verification cases. Authorised people check the configuration against the source, run the verification and publish the change, and installation alone does not validate the end-to-end workflow.

5Where Waters NuGenesis is the better fit.

NuGenesis is the better fit when you want a vendor-neutral scientific data archive across many laboratories and instruments, run on your own infrastructure.

• You have instruments and applications from many vendors and want one archive and one viewer for NMR, MS, LC-MS, IR, UV/Vis and chromatography data.¹
• You need to capture printed reports from applications without a usable export, or convert data to standard formats such as JCAMP-DX for long-term retention.¹
• You run Empower and want the scientific data repository from the same vendor.³
• You want an analytical notebook, sample management and stability in one Waters system, in some cases without a LIMS.²
• You want test requests, specifications and results exchanged with SAP through NuGenesis Connectors.¹
• Your IT team prefers to host and operate the system on its own Oracle and Windows infrastructure.⁴

6Where Seal is the better fit.

Seal is the better fit when instrument data should be part of the work it supports, from the result to the batch decision and the investigation.

• You want each acquisition attached to its sample, batch and investigation through relationships between records, not a filename or a path.
• You want completeness checked by file role, so a missing audit trail or a late companion file keeps the package open.
• You want laboratory, manufacturing and quality on one set of records. An out-of-specification investigation then links back to the sample, method, instrument file and specification behind the result.
• You expect capture rules, parsers and mappings to keep changing. Each change becomes a new version with its specifications, test evidence and approvals, and existing acquisitions keep the configuration they were captured under.
• You want an AI agent that prepares the evidence. Neil gathers the acquisitions behind a batch or investigation, compares two reports and prepares capture changes with their verification; unsupported formats and unresolved matches stay visible. People approve, and Neil never releases a change on its own. In line with the EU’s draft GMP Annex 22 on AI, Neil is not used in GMP execution. It helps set up configuration, which your team verifies and releases under change control.

7Running Seal alongside Waters NuGenesis.

You do not have to replace NuGenesis to start. Seal has no dedicated NuGenesis connector, but it can collect the exports your instrument software already writes. Seal’s Waters connection collects chromatography results exported from Waters Empower with the Seal IoT app and maps them to sample and result records with a Seal Script; export content depends on the configured Export Method, and the Empower guide works through an example.

For NuGenesis itself, Seal’s REST API and Scripts can connect a system that is not on Seal’s integrations list. Waters publishes software development kit reference guides for NuGenesis LMS and its SDMS.² Agree the records, the direction of transfer, the credentials and the failure handling before setting up the connection, and start with read access.

Agree which system owns each record. NuGenesis can remain the long-term archive while one instrument workflow runs in Seal. Preserving a proprietary file and interpreting its contents are separate capabilities, so verify the formats, extraction and mappings for each source, and review ambiguous matches rather than attaching a result to the wrong sample. The regulatory guide covers how to qualify the connection.

8Moving from Waters NuGenesis to Seal.

Prove one source before expanding, and keep NuGenesis as the archive for everything else.

1. Choose one representative acquisition and the workflow it supports, such as a release assay on one HPLC.
2. Confirm the vendor interface, file formats, required companion files, ownership and review expectations. Start with sample material, or arrange an NDA before sharing confidential records.
3. Install Seal IoT on a Windows or macOS host with access to the export folder. The documented folder-upload route uses outbound HTTPS on port 443 and needs no inbound ports; confirm the account, allowlist and startup arrangement with IT.
4. Neil prepares the capture template and its checks, and your team checks them against the source. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
5. Include a late file, a duplicate transfer, a clock discrepancy and a failed integrity check in the evaluation, and show what happens when expected evidence is absent.
6. For an archive migration, scope the native files, renditions and missing evidence first, verify identity mappings, file integrity and sample or batch relationships, and label a legacy PDF as a rendition when the native original is unavailable.

Retention obligations continue for the records that stay in NuGenesis. The SDMS blueprint describes capture, review and retention in Seal in detail.