Low-Ops.AI
Low-Ops.AI for Pharma & life sciences

Accelerate science without compromising data integrity.

R&D, QA, regulatory and manufacturing teams want AI assistants for literature, deviations and submissions — but IP and GxP data cannot leave a validated environment. Low-Ops.AI gives scientists a governed self-service portal to build and deploy inside your own infrastructure, with IT and QA in control.

Supports your obligations under
  • GxP
  • GAMP 5
  • FDA 21 CFR Part 11
  • EU Annex 11
  • GDPR
  • EU AI Act
01What's at stake

What gets left on the table in pharma.

Most IT departments are not equipped for the volume of ideas coming from the business. In your sector, every week an idea waits is value you do not get back — and the upside of shipping it safely is larger than most.

  1. 01

    Your IP is your company

    Molecule data, trial results and process know-how pasted into public AI tools is an irreversible leak. Private by default is the only acceptable default.

  2. 02

    Data integrity is audited

    ALCOA+ principles need attributable, traceable records. Who built, changed and deployed a tool matters as much as what it does.

  3. 03

    Validated change is slow by design

    Every new system goes through qualification. A platform that standardises how apps are built and deployed shrinks the surface that needs validating each time.

02Sound familiar?

Three people, one bottleneck, one platform.

The CIO needs control, the executive needs results and the people doing the work need a tool this week. Low-Ops.AI is built so each of them gets exactly that.

CIO / IT & QA leadership

Ungoverned AI experiments across sites

Scientists trial tools faster than QA can assess them, with no central inventory or audit trail.

Executive leadership

Stuck between pilot and production

Promising AI assistants die in the gap between the innovation lab and the validated environment.

Scientists & QA specialists

Months for a tool that takes an afternoon

A deviation-triage assistant or sample tracker is hours of work — and an endless queue of change requests.

03Digital employees

Digital employees your teams could ship this quarter.

Each of these is a few hours of building for someone who knows the work — and a permanent digital employee once it is deployed through the Low-Ops.AI portal. Private by default, governed by IT.

01by Quality assurance

Deviation & CAPA triage assistant

Classifies deviations, suggests root-cause categories and drafts CAPA language for QA review.

02by R&D

Literature & patent monitor

A private agent that scans and summarises new publications against your research programmes.

03by Regulatory affairs

Regulatory submission helper

Assembles sections from approved source documents with full traceability to the originals.

04by Lab operations

Lab inventory & sample tracker

Replaces spreadsheets with a small governed web app, scannable from the bench.

05by Manufacturing & QC

SOP Q&A assistant

Answers from current, approved SOPs only — nothing from the public web.

06by Clinical operations

Clinical site communication drafts

Drafts site letters and status updates from trial-management data, reviewed before sending.

04Built for your governance model

Speed for the business. Control for IT.

Governance is not a layer we add afterwards; it is how the platform deploys. Every app and agent gets the same guardrails on day one — so IT can say yes faster.

100% self-hosted · open-source core · no per-seat licences

✓

Separate, repeatable environments

Development, test and production environments per app, deployed the same way every time.

✓

Attributable audit trail

Every build, deploy and access event is recorded — supporting ALCOA+ and Part 11 expectations.

✓

Controlled promotion

Promotion to production is an explicit, logged step. Nothing reaches a validated environment by accident.

✓

100% self-hosted, in-region

Runs on your own infrastructure or private cloud. IP and GxP data never leave your boundary.

03How it works

From idea to governed digital employee in three steps.

Every app and agent follows the same paved road. Software-engineering best practices, security and audit are enforced automatically — so going fast and staying governed stop being a trade-off.

  1. 01Build

    A domain expert builds it

    Using AI coding assistants or their favourite tools, a domain expert turns an idea into a working agent or web app — following the simple Low-Ops.AI app spec that AI assistants understand natively.

  2. 02Deploy

    They click deploy in the self-service portal

    Low-Ops.AI provisions the database, CI/CD pipeline, SSO, backups and private hosting automatically. No tickets, no infrastructure, no waiting.

  3. 03Govern

    IT sees everything, by default

    Every app and agent appears in the central oversight portal with its owner, environments and audit log — private by default, reachable only via the corporate network.

The ideas in the queue

See what R&D is waiting to ship.

A short working session. We look at the site and QA ideas stuck behind hosting and review, and how to put the next three on one governed platform.