Platform · AI-native GxP work

Your GxP processes. Run AI-native.

traqx runs SOPs, validation, qualification, reviews and approvals in one controlled workflow — instead of bolting AI onto document chaos after the fact.

Sources first, draft second — every statement stays connected to its source.
Human review before every approval — the AI drafts, your team decides.
Audit trail, version and rationale connected — the validated state stays traceable.

Work on traqx. Integrable with your existing systems.

Choose your entry point → See the trust architecture →

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What the platform is

Not a QMS tool with AI bolted on.

traqx is built from the ground up for regulated work. The platform knows not only tasks and status, but sources, draft logic, review paths, approvals, versions and evidence. As a result, AI stays no loose text generator, but a controlled, verifiable step in your GxP workflow.

Sources first, draft second

Other tools layer AI onto existing document chaos. traqx proposes nothing that is not bound to your knowledge base and a provable source — every statement stays traceable.

Review path as the foundation, not an afterthought

Sources, draft logic, review paths, approvals and versions are anchored at the core. This makes every statement verifiable — reviewable from the very first draft.

Configured along your way of working

traqx is configured along your SOPs, templates and process logic — your framework is not pressed onto a tool. Your conventions stay your conventions.

As a result, AI stays no loose text generator. It becomes a controlled step in your GxP workflow — traceable, verifiable and without a compliance shortcut.

The trust architecture

Generate · Verify · Monitor.

traqx drafts along your SOPs and templates, makes every review traceable and keeps the validated state visible. When sources, requirements or documents change, it becomes immediately visible what needs to be reviewed, adjusted or re-approved — before an audit asks.

Generate — verifiable drafts from approved sources

The AI produces structured drafts from your approved sources — templates, SOPs and knowledge architecture. Every piece of content is marked as an AI suggestion until approval and is bound to its source. Verifiable, not just formally complete.

GenerateDrafts emerge from your approved sources — every block source-bound.

GenerateEvery regulatory statement ends on a clickable source.

GenerateAn unsupported citation is marked as unverified — never output as fact.

Verify — source binding, source checking, human approval

Source binding, binary source checking and human approval: your team reviews at item level and approves. Only your decision turns the suggestion into a provable, reviewable state. The AI drafts — your team decides.

VerifyBinary source check: passed or not passed — no score, no hidden rating.

VerifyItem-level approval — signed with your name; rejection requires a reason.

VerifyThe AI portion and your edits stay distinguishable in the trail.

Monitor — audit trail, decision logic, open items

Audit trail, decision logic and open items emerge as you work, not at year-end: who, what, when, on what basis, AI-suggested or human-approved. Audit readiness grows alongside — not the evening before the inspection.

MonitorAudit trail: who, what, when, on what basis — immutably versioned.

Monitor21 CFR Part 11 · ALCOA+ — provable, not eloquent.

MonitorCompliant e-signature with a frozen PDF as the artefact.

Illustrative example — no customer data.

Suited to your system landscape

Standalone or layered over existing systems.

Some teams want to run GxP processes directly on traqx. Others already have SAP, eQMS or SharePoint deeply embedded. Both are possible: traqx can carry processes standalone or sit as a controlling layer over existing systems. No obligation to rip and replace, no forced parallel world. On the same provable foundation we carry these GxP disciplines:

Validation & qualification (CSV) — URS to test script, GAMP 5 / Annex 11 / 21 CFR Part 11Out-of-box · today

SOP management — creation, maintenance, versioningOut-of-box · today

Audit readiness — every decision provable; audit trail as architectureOut-of-box · today

Equipment qualification — IQ/OQ/PQ to your templatesOut-of-box · today

Process validation — to your validation modelOut-of-box · today

Cleanroom qualification — along your cleanroom SOPs and Annex-1-relevant requirementsOut-of-box · today

CAPA — flows along your SOPsIn preparation

Change control — changes to the validated state, controlledIn preparation

Supplier qualificationIn preparation

Out-of-box — available todayIn preparation

Regulatory-ready, without a jargon show: The platform is built for ways of working that align with GAMP 5, EU Annex 11, 21 CFR Part 11 and ALCOA+. Not as a badge collection, but as a mechanism: traceable source, human approval, documented change, verifiable audit trail.

One platform. Two entry points.

Start with the Workspace. Grow into the Suite.

Two visible doors — bound by the same trust architecture, not by price.

traqx Workspace

GxP knowledge with source evidence

A fast start for teams that want to use GxP knowledge, document reviews, SOP drafts and audit preparation with source binding.

from ~€200 / licence / month

View the Workspace →

traqx Suite

The end-to-end GxP lifecycle

The planned entry point for organisations that want to build end-to-end GxP workflows with controlled document chains, roles, states and approvals.

Terms discussed individually

View the Suite →

One platform, many GxP disciplines

Choose your entry point.

Many GxP disciplines follow the same logic: policy → SOP → templates, with roles, responsibilities and approval workflows. We roll out the detail pages step by step — the rest we test and configure against your framework.

Systems & equipment

CSV / validation Equipment IQ/OQ/PQ Process (CPV) IT infrastructure

Quality processes

SOP management CAPA Change control

Audit & supply

Audit readiness Cleanroom (Annex 1) Supplier qualification

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 the foundation on one real process.

We test on a real process how deeply traqx should reach into your landscape — not a platform pitch, but one system or process, one standard, a clear scope. You assess on your own material whether source binding, review logic and approval are robust enough for your organisation.

Check your use case → Start with the Workspace →