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An assistant that reads your documents against standards and cites sources

Assess a document against the regulatory standard you choose, see gaps with source references, and chat with your documents to find what you need in seconds.

AI-assisted review
EU GMP Annex 15EU GMP Chapter 4FDA 21 CFR Part 11

Regulatory Assistant and GAP Analysis

Axon · AI

Illustrative interface rendering. Real screens and recordings live on the module pages.

Regulatory compliance check and GAP reportReal product screen
Regulatory compliance check and GAP report
Source-cited document Q&AReal product screen
Source-cited document Q&A
Screen recording: document Q&A assistant

Regulatory Assistant and GAP Analysis

Who it is for: Quality teams, validation specialists, managers preparing for audits

  1. Regulatory GAP analysis

    Assesses the selected document against a standard and produces a report with sections, identified gaps and a reference table.

  2. Document Q&A

    Runs vector search (RAG) across protocols, templates, reports and FMEA records and shows the source, page and similarity score behind each answer.

  3. AI records in the audit trail

    Every AI request is written to the audit trail with the model, input summary and engine version.

  4. Scope control

    The user decides which set of documents answers are limited to.

Make audit day an ordinary day.

In a short demo we look at your own use case together.