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Live webinar · 26 August 2026 · 11:00–12:00 CEST

A requirement changes. Which GxP documents are affected?

Only in this webinar do we show live how traqx turns a regulatory requirement, release note, audit finding or CAPA into a reviewable change process: assess the impact on existing documents, draft the required changes, and have the accountable human review each proposal and decide what is incorporated.

60 minutes · online · including live Q&A
  • 26 August 2026 · 11:00–12:00 CEST
  • Live in traqx · synthetic demo data
  • Pharma · MedTech · Biotech · CDMO/CMO · CRO

Your 60-minute agenda

Humans direct. traqx works. Humans review.

See the work path in traqx — from the change trigger through impact analysis and traceable change proposals to subject-matter confirmation. We then answer your questions exclusively in this session's live Q&A.

  1. 01Change & source space

    Which documents and sections are affected?

    A new regulatory requirement, release note, audit finding or CAPA requires changes to existing GxP documentation. We show how the human scopes the change trigger, the relevant source space and the expected work state.

  2. 02traqx analyses & drafts

    How are the impact analysis and changes prepared?

    traqx compares the change against Change trigger · existing documentation · policies, SOPs and project context and prepares Impact analysis · affected documents and sections · traceable change proposals with sources and rationales for review.

  3. 03Human review

    What must the human review and confirm?

    Source, impact, change proposal and open points remain visible on the work object. The subject-matter expert reviews each proposal, corrects or rejects it and decides what is incorporated into the documentation.

✓ Realistic GxP work case✓ Synthetic demo data✓ Reviewable system state✓ 15+ years of GxP/CSV practice by the founder

Why GxP AI needs more than a demo

Fast output is not enough. GxP work must remain reviewable.

Without controlled context, visible sources and a clear review boundary, fast AI groundwork simply creates new rework.

  1. 01 · Context

    The relevant knowledge is spread across many sources.

    Policies, SOPs, templates and project documents must be scoped correctly for the work case.

  2. 02 · Groundwork

    A plausible AI answer is not yet a reliable work state.

    For GxP work, reviewers must see which source supports a statement and what remains open.

  3. 03 · Review

    Changes need a status, source and rationale.

    Reviewers need to assess proposals in context instead of reconstructing the reasoning afterwards.

  4. 04 · Accountability

    The subject-matter decision remains human.

    Experts accept, correct or reject. The accountable quality and approval process remains decisive.

The webinar shows this division of work through a concrete GxP work case — not as an abstract product presentation.

Live, not a polished demo

See more than the result. See how it is produced.

Only in this webinar do you see how traqx compares a change trigger with existing documentation and applicable requirements, identifies affected documents and sections, and returns change proposals to the human with visible evidence and open points.

  • Change trigger · existing documentation · policies, SOPs and project context
  • Impact analysis · affected documents and sections · traceable change proposals
  • The subject-matter expert reviews each proposal, corrects or rejects it and decides what is incorporated into the documentation.
ttraqx · Synthetic demo · no customer data
CHANGE CONTEXT
Change triggerRegulation · release note · finding · CAPAExisting documentationSOP · work instruction · validation documentApplicable contextPolicy · template · project sources
traqx ANALYSES & DRAFTS
ImpactAffected documents and sectionsChange proposalPrepared in the existing documentRationaleSource and reason linked
✓ Impact and sources remain traceable
EXPERT REVIEWS
ImpactProposalIncorporation
Illustrated system state · synthetic demo data

For GxP professionals

One way of working across industries. With a clear scope.

Across pharma, MedTech, biotech, CDMO/CMO and CRO organisations, the same question applies: how can AI prepare work without blurring subject-matter accountability and system boundaries? The common scope is document-based GxP quality work; existing systems of record and accountable approval processes remain decisive.

01 · Quality & Compliance

Assess control and traceability.

See what is supported, what remains open and where a human decision is required.

02 · Validation · QA · RA

Assess GxP AI in a concrete work case.

Understand how sources, templates, documents and review come together in a controlled work state.

03 · Process Owner & SME

Delegate work while retaining the decision.

See where traqx prepares research, drafts and updates — and what remains with the accountable expert.

What you take away after 60 minutes

Assess GxP AI against a reliable standard.

You will understand the controlled division of work, have seen it in a realistic GxP work case using synthetic demo data, and know how to book a start session and begin with your own work case in traqx for free.

  1. 01Which GxP work case is suitable for a first step?
  2. 02Which sources, statuses and review steps must remain visible?
  3. 03How do you book your free start with traqx afterwards?