traqx

FAQ · before your first process

The questions before your first GxP process.

Setup, data protection, model training, validation, pricing, deletion and system integration — answered soberly. What runs today is named clearly; what is configured is not claimed; what is reviewed internally is laid out concisely. If traqx does not fit your process, we say so clearly.

GenerateAI suggestion, source-bound — marked as a suggestion until approval.
VerifyYou review at item level and approve — signed with your name.
MonitorAudit trail: who did what, when and on what basis — immutable.

For Quality, IT and business

For teams that have to decide cleanly internally.

This FAQ is not meant to sound promotional. It is meant to help QA, IT and business clear the first questions quickly: How does traqx work with data? What is trained? What stays with the customer? What is Workspace, what is Suite, what does a pilot need?

01 21 CFR Part 11 audit trail Every action with timestamp, person, source and origin (AI or human). Not a retrofitted log file, but architecture.
02 Human-in-the-loop by design No mode in which a document is validated without human approval.
03 When the AI gets it wrong No AI content is evidenced before you have approved it at item level; every suggestion carries its source. What cannot be evidenced is marked as unevidenced, not presented as fact.
04 Your data stays yours AWS Frankfurt, EU; DPA, subprocessor, data flow and region are disclosed in the Trust Pack. No model training on your data, tenant isolation. Schrems II assessment scope-bound, not a blanket claim.
05 Standards GAMP 5, EU-GMP Annex 11/15, ALCOA+, 21 CFR Part 11.
06 Vendor qualification At pilot/commercial launch: self-validation dossier, supplier audit package, contractually assured source-code escrow, continuity commitment.

What you ask most often

Frequently asked questions.

How fast — and what does setting it up cost?

You start from your templates (no migration, no rebuild) → days instead of weeks to the first evidenced result. Alongside the licence there is a one-off onboarding component; we set the scope transparently before you commit.

Who sets it up?

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

Who gives final approval — traqx or our team?

Your team. The AI drafts and supports the review. Approvals stay human, traceable and role-based. traqx keeps source, version, decision and audit trail together.

What comes after the pilot?

SOP management and audit readiness from day one, change control in preparation; deviation/CAPA, supplier qualification, EQ/CRQ/PV as configured use cases. No shelf of modules — one foundation we configure along your framework.

Is traqx itself validated?

Self-validation dossier + disclosed development processes, so that you qualify traqx as a supplier within your CSV. You are responsible for the validated use.

Pricing?

The entry point is transparent: traqx Workspace from ~€200 per licence per month, plus a one-off onboarding component — we fix its scope before you commit. Suite terms depend on scope, use case and system landscape; we clarify them in the first conversation.

Do we have to replace our existing systems?

No. traqx can carry processes on its own or work as a layer over existing systems such as SAP, eQMS or SharePoint. 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.

Does traqx train models on our data?

No — no model training on your data, governed in the DPA with subprocessors and data-processing notices. Hosted in AWS Frankfurt, EU. 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 approval are made visible.

Model updates?

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.

And if traqx does not deliver?

Source-code escrow and continuity arrangement in the commercial contract. No black box, no vendor lock-in.

What traqx is built on

traqx principles.

Six sentences that bind product-relevant decisions at traqx — and that you can hold us to.

01 The AI suggests, the human decides. No autonomous compliance.
02 Every statement carries its source. Evidenced down to the standard, not eloquent.
03 Your framework, not ours. We map your framework — you configure the precedence rules.
04 The audit trail is architecture, not a feature on top.
05 No system switch. Your templates, your structure, your stack stay.
06 Honest maturity. What is live, is live; what we configure, we say as such.

Security & standards · built for traceable evidence

Made in Germany GDPR-compliant · EU-hosted No model training on your data
Built forGAMP 5EU-GMP Annex 1121 CFR Part 11ALCOA+
MembershipsISPEPDAGQMA

Founded by CSV experts with 15+ years of domain expertise

The next step

Test traqx on your process.

Three keywords are enough: which system/which process, which standard, what is currently slowing you down. The first conversation is not a sales pitch, but a short use-case check covering scope, data control and the next step. If it is not a fit, we say so just as clearly.

You get a concrete next step. The documented assessment is yours; the source room is deleted on request with evidence.

For board/steering: on request, a one-page overview (value, risk coverage, what stands today) as a shareable basis for decisions.