metroliq
Validation · GAMP-style · CSV

Our OQ runs itself — in your instance, after every upgrade.

Supplier validation evidence is part of the platform: our functional specification, our test specification, and our test suite executing in your instance — plus the workspace where you build your own validation file on top of it.

We did the supplier half properly, and we make your half take days instead of months. Software validation in a regulated lab is usually a binder of screenshots that is out of date the day the vendor ships an update. Metroliq ships changes in hours and days, so the supplier evidence had to become executable and your validation file had to live in the system it describes.

How it works

From requirement to signed evidence

  1. 01
    Requirements

    A requirements traceability matrix lists what the system must do — calibration, uncertainty, signatures, audit trail, certificates, quality records — each with an identifier.

  2. 02
    Installation qualification

    The IQ report records the deployed versions, configuration and environment of the workspace.

  3. 03
    Operational qualification

    The OQ executes checks against the live workspace — verdict logic, signature gates, refusals, audit chain — records the evidence, and signs it.

  4. 04
    Performance qualification

    you run your own process end-to-end, with your acceptance criteria, on your own data.

  5. 05
    Report

    A validation report ties requirements to evidence. Kept as a controlled record.

  6. 06
    Re-run

    After every change. Because the OQ is executable, revalidation is a run, not a project.

What the kit contains

Documents and evidence

Included in the platform

  • Requirements traceability matrix
  • Installation qualification report
  • Self-running supplier verification suite, executed in your instance, with signed evidence
  • A workspace for your URS and PQ
  • Validation report
  • Content packs installed idempotently and audited, so a workspace setup is reproducible

How the engineering behind it is tested

  • Independent re-derivation of the metrology maths (272 checks: decision rules, budgets, sensitivity, formula evaluation, dates)
  • Tenant isolation suite (89 probes across records, tools, workflows, channels, integrations)
  • Certificate fidelity suite (73 checks across HTML, PDF and DCC: verdicts, rounding, wording, amendments, receipt dates)
  • UI route walk (54 routes including the portal) and modal-flow walk (11 flows) on every build
  • Multi-model adversarial reviews and an assessor-style certificate review, with findings closed in code

What remains yours

  • Your URS and risk assessment (GAMP category 4 configured product)
  • PQ on your own procedures, templates and instruments
  • Periodic review of the audit trail (the platform flags it when overdue)
  • Your SOPs for the use of the system — drafts can be generated from the record
In the product

Supplier evidence, your validation file, and the audit trail

Supplier validation evidence: RTM, IQ, OQ and configuration checks
Requirements traceability, IQ, OQ run and PQ from one screen.
For your auditor

Give your auditor direct, read-only access — without a tenant login.

This same evidence — the functional specification, the test specification, the executed test reports and the clause-by-clause checklist above — is also reachable by your GxP auditor directly, without a tenant login and without your quality team relaying documents back and forth. Access is a named, time-boxed grant we issue on request: a username and a one-time password good for a bounded window, revocable the moment it's no longer needed, and read-only end to end — an auditor session cannot change a record anywhere in the platform.

This is not self-service signup — it is a credential issued to one named person. Ask your account contact to issue an auditor grant, or if your auditor already has one, they can sign in directly at the audit room. Once inside, they see the gap register published above the evidence rather than folded into it, the hash-chained audit trail they can verify independently, and a dated question log visible to whoever audits us next.

Questions we get

Validation questions

Is the platform validated?

The platform ships with an executable supplier verification suite and its own engineering test gates. Validation of your use of it — your URS, your PQ — is yours; we provide the FS and test evidence, IQ, OQ evidence and the report to build on.

How do you handle updates in a validated environment?

Every change is deployed with the test gates green and the OQ re-runnable. You re-run the OQ in your workspace after an update; the evidence is signed and kept.

Can we get the validation documents before a pilot?

Yes. Ask in the pilot request; the RTM and the OQ run can be produced on a demo workspace.

Can our external auditor review this evidence directly, without going through us?

Yes. We issue your auditor a named, time-boxed, read-only credential to the audit room — a separate surface from the platform itself, no tenant login involved. See "Audit room" above for how to request it.

Beta · free while we build it with the first labs and plants

Bring one lab and your real history.

The tour runs the working platform, not a mockup. Pilot on your own instruments with your own imported history — we set it up with you, and fixes ship in hours and days, not release cycles.