GxP operations.
Ready to evolve.

Seal connects process development, lab, manufacturing and quality work. neil is the AI agent that investigates across your systems and turns procedures into working processes—for your team to test and approve.

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Illustration of a seal beside a procedure unfolding into execution checks and review evidence.

The batch. Its results. The review.

Choose a connected record
Seal batch B-041 with process readings and references to lab sample IPC-041 and investigation DEV-018

The batch carries its readings, lab sample and investigation together.

Batch record

Seal batch B-041 with process readings and references to lab sample IPC-041 and investigation DEV-018
An operator working at MiAlgae’s production facility

MiAlgae cuts documentation time by 75%.

MiAlgae brought its ELN, quality processes and electronic batch records into Seal as it scaled from lab to commercial production.

See how MiAlgae uses Seal

Keep the systems you rely on.

Connect Veeva, ERP and lab systems. Ask neil to query permitted records and prepare a source-backed report. Start with the evidence where it lives; you do not need to move everything into Seal.

Explore the connections
Veeva Vault

Controlled documents and quality context

SAP

Production, material and business records

SharePoint

Procedures and supporting files

NetSuite

Inventory, suppliers and transactions

Choose what each connection is allowed to do

Available records and actions depend on the source, edition and configured connection. Agree library captures, API access or data transfer for the job. Keep source permissions, sync freshness and any write-back explicit; connecting a system does not grant unrestricted access.

From scattered evidence to a reviewable investigation.

You: Investigate the extended hold on B-041. Bring the evidence together and draft the investigation.
neil

I’ve brought the batch, instruction and lab evidence together. The overrun is confirmed; its cause and product impact still need investigation.

B-041 / hold-time investigation

Draft

Confirmed against the instruction used

The recorded hold was 52 minutes. MBR-014 v04 permits 45. The batch exceeded that limit by 7 minutes.

Allowed45 min
Recorded52 min

What is not yet established

Why the transfer was delayed, and whether the extra hold affected the product. The lab results alone do not close that question.

Evidence to request next

ManufacturingTransfer, equipment and handoff records.

Technical reviewAn assessment of the extended hold and lab evidence.

Read the full investigation draft

Finding

The selected batch record shows 52 minutes between mix completion at 10:12 UTC and transfer completion at 11:04 UTC on 5 September 2026. MBR-014 v04 clause 7.2 permits 45 minutes. The recorded hold exceeded the requirement by 7 minutes. Sources: B-041 step 07; MBR-014 v04 clause 7.2.

What is not yet established

The records do not explain the delay or establish its effect on the product. IPC-041 has recorded results, but an approved hold-impact assessment is absent. A passing result, if confirmed, would not by itself establish that the extended hold was acceptable. Source: IPC-041.

Evidence to request

Manufacturing: verify the source timestamps and obtain the contemporaneous account of the transfer delay, including equipment and handoff records. Technical review: assess the hold-time knowledge and whether the sampling and results address the exposure. Quality: retain the exception and determine the review and disposition requirements. Keep missing evidence visible until supplied.

Proposed process improvement

Assess an elapsed-time calculation using required start and transfer timestamps, with an exception route above the existing 45-minute limit. Do not increase the limit to accommodate the observed overrun. This control could improve detection and escalation; it is not evidence of root cause or a demonstrated corrective action.

Decision status

Investigation, product-impact assessment and batch disposition remain open. The proposed configuration is separate work requiring specification, verification, training assessment and authorised release. No source record is changed by this draft.

About these records

A prepared conversation using fictional records. Inspect the evidence and follow the investigation; this page does not query a live system, change a process or release a batch.

Example evidence

Your process, without a custom software project.

neil proposes the next workflow from your instruction. Required fields, a calculated hold and an exception path—ready for your team to try and review.

Example procedure

Transfer within45 minutesof completing the mix.

MBR-014 / clause 7.2

Inspect the proposed configuration
Capture
Mix completed and transfer completed.Required date and time fields.
Calculate
Elapsed hold in minutes.Derived from the two timestamps.
Route
Beyond 45 minutes, require an exception assessment.Missing or reversed timestamps cannot satisfy the check.
Connect
The batch, source readings and investigation.References to records, not copied identifiers.

Try the proposed workflow.

52minutes elapsed

Exception assessment required

The hold exceeds 45 minutes. Assess the exception before deciding how to proceed.

Explore dates and boundary cases

Example times in UTC. Clear a value to try the missing-input check.

This local preview does not change a batch or approve a process.

Validated should not mean frozen.

The next version gets its own specifications, test evidence and release review. Earlier executions keep the version they used.

Explore continuous validation

  1. Propose the next version

  2. Keep its evidence connected

  3. Your team approves

With every improvement.
Explore the example change and its test evidence
Proposed changev05-b

Require both
timestamps.

Calculate the hold. Route overruns for assessment.

Required inputsStart + transfer time
Existing limit45 minutes

Evidence for this version

Earlier evidence stays intact.

Example evidence

This example adds required timestamps to a hold check. The missing-time test failed in v05-a and passed after correction in v05-b. The access check is still not run, so the release review remains open.

Testing a 45-minute hold limit
CheckBefore fix / v05-aAfter fix / v05-b
44 min: within limit
45 min: within limit
46 min: exception
Missing time: blocked
No authority: blocked

Example tests, not batch approval. Select a result to inspect.

Example evidence

Evidence and release requirements

B-041 keeps v04. The correction adds a new result; it does not replace the failed run. In the example, 4 selected checks passed; 1 access-path check is not run. ANOM-006 still needs review. Training assessment and release approval remain open. The hold limit remains 45 minutes.

GAMP 5 Second Edition supports risk-based lifecycle assurance, including iterative specification and verification. FDA’s CSA guidance addresses medical-device production and quality management system software. The assurance effort follows intended use and risk.

Your team assesses the configuration and supporting evidence, performs any additional user acceptance testing and approves release. Continuous validation does not mean automatic approval.

Start with the work you need.

Adapt a blueprint to your procedures. Connect the next process when you’re ready.

Before you start.

Can we change the system after it is validated?

Yes. Continuous validation means managing the validated state through change, not freezing the configuration. Keep the reason for the change, affected requirements, updated specifications, verification results and approvals together in Seal. Assess the impact and risk to determine the assurance needed. Automated checks support that assessment; they do not replace accountable review or any additional UAT your intended use requires.

Read about continuous validation

Do we need to replace our existing systems?

No. Start with a defined job and the records it needs. neil can work with connected systems; processes you choose to run in Seal can be introduced in stages. Agree which system owns each record, what can be read or written and how the connection will be verified.

Explore the integrations

Is Seal a LIMS, an MES or a QMS?

Seal is one configurable platform for lab, manufacturing and quality operations. Its blueprints cover laboratory information management (LIMS), electronic lab notebooks (ELN), manufacturing execution (MES), electronic batch records and quality management (QMS). Start with the processes you need; you do not have to implement every area at once.

Find a GxP blueprint

What does neil do, and what does our team control?

neil answers questions using accessible records, investigates results and proposes process configurations and improvements. Your team reviews the source evidence, resolves assumptions and approves changes. A proposal from neil is not permission to release a process or a batch.

See neil at work

Where is our data hosted, and is it used to train AI?

Seal supports choices of region and AI provider. We confirm storage and model-processing locations for your deployment, alongside retention and access controls. Customer data is not used to train AI models; the records neil uses as working context are not training the underlying model.

Review AI and data controls

How quickly can we evaluate our own process?

Once we agree the evaluation scope and receive the required inputs, we prepare the first working process and supporting validation pack within 48 hours. The pack includes source traceability, recorded test results and configuration history. Your team can execute the process and inspect its records. Production release follows your intended-use assessment and quality controls.

What do we need to share to get started?

A short outline of the work and a work email are enough for the first conversation. For a process evaluation, we agree the scope with its owner and use a representative procedure, batch record or form. You can start with a sample, or arrange an NDA before sharing your own material.

See your process in Seal.

Tell us about your process. We’ll show you how it can run in Seal, with the records, review steps and evidence your team needs.

Book a demo