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Start with one deal, then grow.

We begin with a pilot on one pair of systems, in your own cluster. Pricing is on request, once the pilot scope is clear.

What a pilot includes.

Four steps, from the first conversation to a first verified wave.

  1. Step 1

    Evidence for your system pair

    Tell us the two systems you need to connect. We produce that pair’s evidence before the pilot starts.

  2. Step 2

    A Data Estate Scan

    Run in your own cluster. You get the PDF report and a classification your QA team can inspect.

  3. Step 3

    Validation planning

    Evidence maps, the control inventory and test artefacts, executed with your QA team on your infrastructure.

  4. Step 4

    A first wave

    Two signatures, a verified transfer and a compliance report you can hand to an assessor.

What you bring, and how pricing works.

What you bring to a pilot

  • The two systems you need to move data between, and access to them.
  • A Kubernetes cluster for the installation, with PostgreSQL, Redis, NATS, Keycloak, OPA and object storage.
  • A contact in QA, and one in IT or security.
  • An Anthropic API key for classification, or the address of your own AI gateway.

How Mergiva is priced

Each customer gets one dedicated installation in its own Kubernetes cluster. We do not run a shared service.

Pricing is on request, once the pilot scope is clear.

Ask about pricing

What your QA team receives.

Validation is executed with your QA team, on your infrastructure. This is the material it starts from.

Evidence maps

Requirement-by-requirement maps for 21 CFR Part 11 and clause-by-clause for EU GMP Annex 11.

Control inventory

Each control and the mechanism that implements it.

Test artefacts

The unit, integration and end-to-end runs behind each control, and the committed transfer proof.

Runbooks

Operating procedures for incidents, backup and restore.

Before you book a call.

How does a pilot start?

Name the two systems you need to connect, and we produce that pair’s evidence first. Then we run a Data Estate Scan in your own cluster, plan validation with your QA team, and run the first wave with two signatures and a compliance report.

How is it installed?

With one Helm chart into your own Kubernetes cluster. The setup command writes the settings for AWS or your own data centre, and Terraform for AWS is included as reference infrastructure. You provide PostgreSQL, Redis, NATS, Keycloak, OPA and object storage.

How is Mergiva validated?

Validation is always executed in your environment and signed by your people, so no vendor can do it for you. Mergiva is built for GxP, and we supply the evidence maps, control inventory, runbooks and test artefacts your QA team needs. Then we execute the validation with you, on your infrastructure.

Can we see the evidence behind these answers?

Yes. We will share the claim map that ties each statement to the code, the committed transfer proof, and the test runs behind each control.

Start with one deal.

A pilot starts with the two systems you need to connect, and ends with evidence you can hand to an assessor.

  1. 1

    Name the pair

    Tell us the two systems you need to connect. We produce that pair’s evidence before the pilot starts.

  2. 2

    Scan one estate

    Run a Data Estate Scan in your own cluster. You get the PDF report and a classification your QA team can inspect.

  3. 3

    Plan validation together

    Evidence maps, the control inventory and test artefacts, executed with your QA team on your infrastructure.

  4. 4

    Run the first wave

    Two signatures, a verified transfer and a compliance report you can hand to an assessor.

Or write to contact@mergiva-ai.com.