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Rows of glass pharmaceutical vials beneath filling nozzles on a stainless steel production line.

Improve your site’s costliest decision.

Deviations, batch records and QP release set the pace on a biopharma site. We work with evidence your quality team can approve.

Most of what happens on a site is somebody deciding something.

  • Quality

    Can this batch be released?

  • Supply chain

    Will the materials be released before the campaign starts?

  • Engineering and maintenance

    Why has this fault come back, and who knows the fix?

  • Operations

    Can this campaign fit the plan?

The knowledge is on site, a long way from the decision.

Your systems MES, ERP, LIMS and the quality system, not connected to each other.

The written record Deviations, CAPAs and batch records, hard to search.

People’s heads What experience knows, written nowhere.

The decision

Better decisions are where the value is.

Yield, quality, compliance, cost and capacity follow from them.

We start from the decision and work back to the data.

  • We define one decision with you: its owner, its evidence and a good outcome.
  • We read from your validated systems and change none of them.
  • We put the evidence, with its source, in front of the person deciding.
  • We record what was decided and why, and link it to what happened next.
An older technician in cleanroom clothing gestures at a joint in stainless steel pipework while a younger colleague listens, beside a plain grey wall in early sun.

We capture what your experts know and never wrote down.

Searching documents only reaches what someone wrote down.

How far a solution goes is earned.

  1. Assist

    ‘Show me.’

    It gathers the evidence and prepares it for a person.

  2. Advise

    ‘What would you do?’

    It proposes, and a person reviews.

  3. Act

    ‘Do it, and tell me.’

    It acts within limits a named owner has approved, and records it.

No system makes a regulated decision. A person signs the release.

Built for regulated, auditable work.

Traceable
Who decided, when and on which version.
Explainable
The evidence and the reasoning.
Auditable
Every step and hand-off, in order.
Defensible
A named owner for every decision.

Make an impact on the work.

The cover of the Generative AI for Life Sciences Playbook 2025: a production hall washed green, a round photograph of a gowned operator handling vials, and the Connected Health Skillnet, Brightbeam and BioPharmaChem Ireland Ibec logos.

Five life sciences companies built the sector’s playbook with us.

The Generative AI for Life Sciences Playbook 2025 is free to read. The work won the 2026 Collaboration in BioPharmaChem Award.

Read the playbook (opens in a new tab)

Commit in steps, each funded on evidence.

  1. Scoping and Specification

    Is this worth pursuing, and what should we build?

  2. Controlled Trial

    Does it work in a limited version of your world?

  3. Operational Pilot

    Does it hold up with real people doing real work?

  4. Rollout

    Does it run as part of how you work?

So tell us what you’re working on.

Get in touch