AI Document Intelligence — Suggestions a Person Confirms


AI, governed

AI that suggests. People decide.

DnXT uses AI where it saves real effort — classifying documents, suggesting links and bookmarks, extracting dates from correspondence, a first review pass — and a person confirms every suggestion before it changes anything.

AI suggestions
Waiting for a person
Labelled as AI; nothing applied yet
ClassificationProposed: Module 2.7.2, with reason
Confirm
Hyperlink“Table 14.2.1” → CSR-301
Confirm
Review commentBatch size differs from batch record
Answer
ChronologyMeeting date read from agency letter
Confirm
Rules run first; AI handles what rules cannot.
The problem

AI is useful only if regulated work can trust what it touched

Regulatory teams spend hours on work AI can help with — placing documents, linking cross-references, building chronologies, first-pass review. But an AI that changes records on its own, or whose output cannot be told apart from a person’s, is a liability in an inspection.

In DnXT, AI proposes, labels what it proposed, and waits for a person.

Who it is for

Built for the people who own the outcome

Publishers

Get document placement, links and bookmarks suggested, then confirm them.

Regulatory and CMC writers

Receive a first-pass review that only comments, and answer each comment.

Quality and IT

Control which AI features are on, for whom, and through which provider.

How it works

How AI fits the workflow

Rules first

Deterministic rules handle what they can, the same way every time.

AI proposes

For the rest, AI suggests — with its reasoning where relevant.

A person decides

Accept, reject or change; nothing is applied without that step.

The record shows it

AI-originated suggestions are labelled as such.

Capabilities

Where DnXT uses AI

Document classification

Proposes where a document belongs in the taxonomy or the CTD, for a person to confirm.

Links and bookmarks

Suggests hyperlink targets and bookmarks; learns from your team’s accepted and rejected suggestions.

Review first pass

Raises comments on a document — including cross-document discrepancies — that a person must answer.

Chronology and correspondence

Reads dates and events from agency correspondence to build an application’s chronology.

Specifications and labeling

Summarises specification data from Module 3 and changes between labeling versions, in DnXT Reviewer reports.

Meaning-based search

Finds content by meaning as well as by keyword, within what you are allowed to see.

Design decisions

Rules we hold ourselves to

AI never commits

No AI output changes a plan, a document or a record without a person.

AI output is labelled

Comments and suggestions written by AI say so.

Off unless enabled

Each AI feature is enabled per customer and per feature.

Rules before models

Where a deterministic rule can decide, it does.

Questions

Frequently asked

Which AI provider does DnXT use?

AI requests go through the DnXT AI gateway to the provider configured for your company — such as Azure OpenAI or Anthropic. See the AI gateway page.

Can AI features be switched off?

Yes. Each AI feature is enabled per customer and per feature.

See AI that waits for a person

We will run classification, link suggestions and a review first pass on documents of your own.