The questions before your first GxP process.

Formal document approval and e-signature remain in your QMS or another responsible system. traqx prepares the source-bound draft, changes and traceability for human review.

You start from your existing templates — without a migration or rebuild. We define scope, timeline and the one-off onboarding component for the first work case transparently before you commit.

An experienced implementation partner supports the setup; in operation your configurator role manages users, templates and the knowledge base itself.

Your team. The AI drafts and supports the review; your experts correct and decide. traqx keeps source, version, status and audit trail together. Formal approval and e-signature remain in the system of record or another responsible system.

After the demo, you licence traqx with projects, controlled source rooms, Agent Library, Knowledge Library, Template Library and Word document work. Document-based use cases such as CSV/CSA, SOP management, audit readiness, CAPA, Change Control, Supplier Assessment and equipment, process, cleanroom or IT infrastructure qualification are included—with no separate module fee.

Yes. In traqx, an existing Word document can be updated in the context of project sources, policies, SOPs and templates. Today, the result returns as a .docx with visible tracked changes, source and rationale comments, and an updated version history. The reviewer can inspect the document and change state in the Word view inside traqx and continue using the .docx.

For product demo and commercial use, we provide a bounded validation and vendor-qualification package: system description, scope boundaries, data flow, role model, AI-control concept, audit-trail logic, risk assumptions, test approach and evidence for source binding. The product demo is not productive operation; it is a bounded, documented assessment of one real GxP process. You remain responsible for validated use.

We structure the points that can be assessed: hosting region, data flow, subprocessors, roles and permissions, data and model boundaries, deletion logic, export and portability, and the validation approach for the concrete scope. What cannot yet be evidenced is marked as open — not claimed as a certification.

traqx is licensed per user licence and month. Document-based use cases are included without a separate module fee. We discuss the concrete offer in the intro call; configuration and implementation follow scope.

No. traqx can carry processes on its own or work as a layer over existing systems such as ERP, eQMS or document repositories. The right depth depends on your system landscape. The goal is not to rip out working systems, but to run GxP work in a controlled way on traqx.

No. Customer documents stay within the agreed tenant and hosting scope; no model training on customer data. This is governed in the DPA with subprocessors and data-processing notices. Hosted in AWS Frankfurt, EU. AWS Frankfurt refers to the product; the privacy policy describes the separate hosting of the traqx.io website by Kinsta on GCP Frankfurt. The EU AI Act classification is assessed scope-bound and not claimed publicly in absolute terms. Art. 50 transparency is a trust asset: AI share, sources and human review are made visible.

Models are versioned and pinned — no unnoticed change. A version change runs in a controlled and documented way via a traceable change process, including a change freeze in critical phases.

Source-code escrow and continuity arrangements will be anchored in the commercial contract. No black box, no vendor lock-in.