Seal vs LabWare

1LabWare and Seal, side by side.

LabWare and Seal both keep samples, tests and results under audit trail and electronic signature.¹ They differ in what sits around the laboratory. LabWare describes its LIMS as managing the laboratory’s operational workflow, its ELN as the experimental record, and a QMS as a system that works alongside the LIMS rather than replacing it.² Seal configures laboratory, manufacturing and quality workflows on one platform around a shared ontology, so a sample, the batch it came from and any investigation it opens are records in the same system.

2What LabWare is built for.

LabWare is built for laboratories of almost any kind that want one configurable platform for samples, testing, lots and reporting. Vance Kershner founded the company in 1987 in Wilmington, Delaware, and still leads it as President and CEO. It is headquartered there, where all its research and development takes place, and has offices in 25 countries.³ LabWare says more than 30,000 laboratories use its LIMS, across pharmaceutical, biopharma, bioanalysis, clinical, contract services, food, water, forensics, mining, oil and gas and other industries.²

For pharmaceutical work, LabWare offers more than 250 purpose-built modules on its core LIMS and ELN, pharmaceutical template solutions and management of product specifications and control limits, and says 21 of the top 25 pharmaceutical companies use it.¹ The LIMS covers lot management, stability, environmental monitoring, instrument interfacing, sample login, result entry, a batch manager, inventory, a portal for external stakeholders, and training and analyst certification.²

LabWare LIMS incorporates its ELN as a fully integrated add-on.² For GMP samples, the ELN guides analysts through standardised testing methods (STMs): each step of an SOP or STM is set up in LabWare’s Workflow Automation Manager without coding, and method templates are version controlled so they link to the right version of the source document. Compliance limits on any data input can stop a method from continuing when there is a significant deviation. The ELN parses reports from chromatography data systems and has integration modules for Waters Empower, Agilent OpenLab and Thermo Atlas.⁴ Its Compliance View monitors a method’s compliance as the analyst performs each step and can notify supervisors immediately when a deviation occurs, and LabWare offers out-of-the-box interfaces to ERP and QMS systems such as SAP and TrackWise.¹ Administrators train in configuring LabWare with LIMS Basic and in LabWare 8 visual workflows.⁵

LabWare runs where the customer needs it: LabWare SaaS, cloud-hosted by LabWare, validated and pre-configured; LabWare Hosted; the customer’s own cloud; or self-hosted on premises.² Self-hosting suits areas with isolated networks and no external access.⁶ The SaaS edition is designed for deployment in under 30 days and is not available in every region.⁷ LabWare describes machine learning and AI capabilities that anticipate trends, identify anomalous data and optimise operations.⁸

3How a result reaches its lot and specification.

Both products connect a result to its lot and its limits. The difference is where the rest of the lot’s evidence lives.

In LabWare, lot management tracks every batch or lot from submission through to reporting, with data review, lot release functions and automatic certificate-of-analysis generation and approval for each lot.⁶ Product specifications and control limits are managed in the LIMS,¹ and in the ELN a compliance limit can stop a method at the step where a value falls outside it.⁴ Manufacturing stays in a separate system that exchanges messages with the LIMS. In LabWare’s published example with Körber PAS-X, the MES triggers a sample request, the LIMS returns sample details for label printing, the MES confirms collection, and the LIMS sends results back to the MES for further processing.⁹

In Seal, the laboratory record and the batch record are one set of records. In the example in Seal’s LIMS blueprint, sample S-041-12 from batch B-041 is registered with its material, collection point and required tests, and method AM-014 v03 and specification SP-041 v04 are assigned before execution. Its water content result of 0.72% is outside the ≤ 0.50% limit. Investigation INV-041 opens on the same records, with the preparation, working-standard lot WS-041, instrument file and qualification evidence attached, and the original result is retained even if further testing is justified. The laboratory review stays pending while the investigation is open, and batch disposition reads that review rather than a copied result.

Seal keeps three decisions apart: whether the value meets its assigned limit, whether the laboratory evidence is complete and acceptable, and whether the batch can be released.

4Changing a method after go-live.

Both treat a change after go-live as controlled work. The difference is where the test evidence for that change is kept.

LabWare recommends a life-cycle validation approach based on GAMP Category 4, configured off-the-shelf software. Because LabWare has qualified its LIMS and ELN, a customer can focus risk-based testing on its own configuration. LabWare’s validation services build a package that tests the installation, the configured objects against the user and functional requirements, and the business process, and can manage all or part of the effort. LabWare notes that any later change, whether a configuration update, an instrument interface or an upgrade, needs a documented impact assessment and usually some requalification; its validation team assesses the impact, updates test scripts and provides summary reports.¹⁰

In Seal, a method revision is a changeset. Proposed AM-014 v04 carries its requirement, its configuration and its verification. When the changeset is prepared for review, its selected acceptance tests run, including failure cases such as a missing unit, an out-of-range result, an unapproved method version and an incomplete review, and publication requires current passing results. Failures, corrections and retests stay with the candidate revision. Runs on v03 keep the version they used. This assurance covers the software configuration; it does not replace the scientific evidence an analytical method needs.

To compare the two in practice, take one calculation change through each, including a failed test and its retest, and inspect the evidence that remains.

5Where LabWare is the better fit.

LabWare is the better fit when you need one established laboratory platform across many sites, industries and hosting environments.

• You run laboratories in several industries, such as pharmaceuticals alongside food, environmental or clinical testing, and want one vendor across them.²
• You need self-hosting, including isolated networks, or want to run it in your own cloud.²⁶
• Your QC estate is already standardised on LabWare’s pharmaceutical templates and modules.¹
• You want broad interfacing through RESTful/JSON, IoLT/MQTT, XML, ASTM, HL7 and CSV, with named connections to Körber PAS-X, Mettler Toledo LabX, Molecular Devices SoftMax Pro, SAP ERP, Thermo Scientific Chromeleon and Waters Empower.¹¹
• You want the supplier to run much of the validation effort, from strategy and deliverables to execution.¹⁰

6Where Seal is the better fit.

Seal is the better fit when laboratory results should feed the batch and the quality system without being copied between them.

• Your laboratory, manufacturing and quality work should share one set of records. A reviewer follows a reported value back to its preparation, standard lot and acquisition, and an out-of-specification investigation links to the affected batch.
• You want specifications as structured, versioned records. Each result is evaluated against the version assigned to it, and a revision’s impact on samples, methods and certificates is reviewed before it is assigned to future testing.
• You want each configuration change to carry its own test evidence, with earlier runs keeping the version they used.
• You want an AI agent to prepare the work. Give Neil an approved method or specification and it proposes test names, parameters, calculations, acceptance criteria and review gates for your team to check. It can also answer questions across records, such as which batches used standard lot WS-041 and which still have an open laboratory review. 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 LabWare.

You can start with one workflow and keep LabWare as the laboratory record. Seal’s LabWare connection is read-only: it reads approved REST resources and passes the JSON to your Seal Scripts, and it does not write to the LIMS.

Ask the LabWare team which licensed interface exposes the data, its deployed URL and a read-only service account, and obtain the field contract for your configuration. In Seal, open Settings → Integrations → LabWare, enter the narrowest approved HTTPS prefix, a test resource and the authentication header, then choose the resources to share. Supported headers are Authorization, X-API-Key and apikey; SOAP, cookies or a private address need an approved gateway. Mapping, review and scheduling stay in your Scripts.

The connection guide works through a fictional batch, B-820. LabWare returns two results for sample LW-S820: glucose 1.20 g/L, approved, and lactate 0.80 g/L, awaiting review. Seal keeps both original values with their mg/L comparisons and shows two values received and one approved, so the lactate review stays visible as outstanding work. A returned sample ID is not treated as proof of collection, following the request, collection and result steps of LabWare’s PAS-X exchange.⁹ Any write-back to LabWare is a separate integration with its own controls; the LIMS integration guide sets out the checks.

8Moving from LabWare to Seal.

Move one workflow first. LabWare stays the record for the rest.

1. Choose one release test, incoming-inspection workflow or stability study where results should feed batch review directly.
2. Bring the method or procedure, a redacted specification, a representative result and an instrument export. Sample material works for a first look; arrange an NDA before sharing confidential records.
3. Neil proposes the workflow from the approved method and specification, and your team checks it 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.
4. Connect one source: LabWare read-only for the samples and results the workflow needs, or an instrument through Seal IoT, which watches the export folder and keeps the original file with the result.
5. Agree which system owns each record during the transition, how identifiers map and what must reconcile. Evaluate historical records, original files, versions and review status before deciding what to migrate; work outside the scope stays in LabWare.

The LIMS blueprint describes the laboratory workflows in detail, and the regulatory guide the validation approach.