ZANUS AI FOR PHARMA & BIOTECH — BACK OFFICE

Regulatory writing at machine speed.
Judgment stays human.

Deviations, CAPAs, stability reports, annual product reviews, submission modules: pharma runs on documents nobody has time to write. The Zanus back office drafts them from your own records, with every claim cited — and nothing leaves without QA, regulatory or medical sign-off.

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

AI work session drafting a deviation trend report

A real session: deviation trend review — data pulled, narrative drafted, sources cited, QA decides.

What it does

The deviation backlog, drafted

A deviation is logged; the AI pulls the batch record, the SOP and the equipment history, drafts the narrative and a proposed CAPA — QA edits and approves, in a fraction of the usual cycle.

Stability and trend reports on schedule

Monthly stability summaries and quarterly trend reports assembled from the data your team designates, figures cited to source records, filed for review before the meeting.

Submission sections from the archive

Module drafts, responses to information requests and briefing-book sections assembled from your registration archive — in your templates, with the source excerpts attached.

The AI reads the whole archive, not the last folder

Twenty years of protocols, batch records, lab reports and correspondence — the AI drafts with all of it in reach. Ask “have we seen this impurity profile before?” and the answer arrives with the historical records attached, not a shrug.

Cross-references across studies, sites and years
Every claim in a draft cited to its source document
Reasoning streamed live — supervise or redirect mid-work

Regulated document work tracked and prioritized

Regulated documents drafted in company templates

Your templates, your terminology, your sign-off chain

Work types are molded to your quality system: a “Deviation Narrative” work knows your template, your defect taxonomy and your default sources. Finished drafts land in Output, statused and waiting — nothing self-publishes.

Work types configured per document class
Drafts in your letterheads and formats
Sign-off queue with full revision trail

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

Does the AI ever release a document on its own?

No. Every draft waits in Output for the designated human reviewer — QA, regulatory or medical. The sign-off step is structural, not optional.

Can it work from scanned batch records?

Yes — the ingestion pipeline handles PDFs, scans, images and media. Legacy paper batch records become queryable knowledge once scanned and loaded.

The Back Office executes. Who answers the phone?

Front Office AI picks up every call and chat — books, quotes, follows up, 24/7 in 40 languages. Watch it run a business like yours, live.

Front Office live demos →Front Office for Pharma & Biotech