ZANUS AI FOR PHARMA & BIOTECH — COMPLIANCE

Built like the inspection is tomorrow.

GxP documentation discipline is not a feature toggle — it is the architecture. Admin-created accounts, permissions to the field level, server-side redaction, a searchable audit trail, pre-update snapshots with rollback, and an air-gapped option where data never touches the internet.

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Private tenant or your own server · unlimited users · GxP-conscious architecture

Searchable audit log of every audited action

Every audited action searchable: who saw what, who changed what, when — the inspection answer in minutes.

What it does

Attributable, always

Admin-created accounts, no self-signup, every action tied to a named user — the A in ALCOA, enforced by the login system itself.

Blinding and least privilege, enforced

The server redacts what a role cannot see — a blinded team member gets the study calendar without the unblinded fields, structurally, not by promise.

Your programs, your walls

Five-level workgroups separate programs, studies and sites; the on-premises option puts the entire system inside your facility, air-gap capable, USB updates.

The audit answer in minutes, not weeks

When the question comes — from an inspector, a sponsor auditor or your own quality unit — the answer is a search away: access records, document succession, update history, AI work sessions with their reasoning, all in one place.

Searchable audit trail with configurable categories
Automatic pre-update snapshots with rollback
AI work sessions preserved: sources, reasoning, sign-off

Granular per-user permissions for regulated teams

Life-science software is sold per validated seat and per module — a LIMS here, an eTMF there, a QMS somewhere else — while regulatory affairs still re-types the same deviation data into three systems and the literature pile grows over the weekend. Zanus AI: one AI operating system across the trial, the lab and the submission — unlimited users, GxP-conscious by architecture, hosted in your private tenant or air-gapped inside your facility.

Questions, answered

Is this 21 CFR Part 11 compliant out of the box?

We say it carefully: the architecture is GxP-conscious — attributable accounts, audit trail, access control, record protection. Part 11 assessment and validation are performed with your quality unit during onboarding; bring them to the demo.

Where does our data live?

In your isolated private tenant — never training outside models — or fully on-premises on hardware you own, physically incapable of internet exposure.

Built like the inspection is tomorrow.

What it does

The audit answer in minutes, not weeks

Questions, answered

See it working on YOUR lab — the demo IS the product.