GxP Compliance Intelligence · for regulated life-sciences teams

Provable AI for GxP. Control stays with you.

AI drafts, your team reviews and approves. traqx runs SOPs, CSV documentation and audit preparation with source binding, versions and an audit trail — without a system switch.

AI drafts. Your team reviews and approves. Every approval carries a name.
Sources, versions and the audit trail stay connected — EU-hosted, no model training on your data.
Live on a real process within weeks — without a major IT project.

Check your use case → Start with Workspace →

Generate · Verify · Monitor

Which version is the current one? Where does this requirement come from? Who approves it in the end — and on what basis? Your team doesn't need another repository, it needs a controlled workflow.

Core Principles

Generate. Verify. Monitor.

Not a QMS tool with AI bolted on afterwards — a controlled way of working. AI drafts, your team reviews and approves, the validated state stays traceable. Sources, versions and the audit trail stay connected, instead of turning AI work into a shadow process.

Generate · Verify · Monitor

The foundation of every interaction: traqx drafts, you review and approve — the system evidences every step. No autopilot, but a tool you steer.

GenerateStructured, verifiable drafts from your approved sources: SOPs, templates, policies, industry guides and validation-relevant requirements — verifiable drafts instead of empty forms.

VerifyEvery output is backed by sources and made humanly verifiable via the clickable Citation — the source check is binary: pass or fail. (Formal approval: Suite.)

MonitorApprovals, changes, source references and open points stay traceable — no shadow process.

Ghost Values

An AI suggestion sits visibly alongside — until you accept it. The AI never writes silently into a validated record; until approval, your content counts as unchanged.

Current · v3 Versions every change with timestamp and user ID.

AI suggestion · pending …with timestamp, user ID and rationale.✕✓ Accept

Human-in-the-Loop

Every approval is an attributable decision — with a mandatory rationale on rejection. The friction is intentional: it captures your attention at the exact moment of record.

◆ Rejecting requires a reason✕ Reject

Reason for rejection (required)

e.g. wording doesn't cover the OOS edge case …

Citation & source binding

Every regulatory statement ends on a clickable source. A fabricated Citation is clearly flagged as unverified — not presented as truth.

Electronic signatures satisfy identity & signing intent.SOP-CSV-0012 §4.2

Limit set to 0.5%.⚠ UNVERIFIED · source not in pool

Deterministic check

A deterministic mechanism checks every source reference: does it really point to the approved source pool — yes or no? No probability score, but a clear pass / fail. A fabricated Citation fails and is flagged as unverified.

Citation check✓ passed

Source in pool✓ present

Fabricated citation✕ failed · unverified

View all mechanisms →

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

One platform. Two entry points.

Start with Workspace. Grow into Suite.

traqx Workspace

Your controlled first GxP process

For teams that want to start one real GxP process small and clean: SOP drafts, reviews with a source and audit preparation — verifiable, controlled, without a major IT project.

from ~€200 / licence / month

Start with Workspace → One process, one source space, source-checked drafts.

traqx Suite

The complete GxP lifecycle, guided

For organisations that want to bring SOPs, validation, qualification and audit preparation into one shared, guided working logic — instead of handling each topic in isolation.

Terms discussed in conversation

Check your Suite fit →We'll work out with you which depth fits your landscape.

Why traqx

The version is right. The rationale is missing.

It isn't missing knowledge that costs time — it's friction

Your bottleneck is rarely the facts. It's the handful of experts who reassemble every decision themselves: scattered sources, drafts to re-check, changes with no rationale — and right before the audit, someone asks again: is this the current version?

A platform that runs your processes

traqx connects sources, AI drafts, human review, approvals, versions and the audit trail in one flow of work. Your GxP processes aren't simply filed digitally — they're run under control: traceable, verifiable — and with no compliance shortcut.

Standalone or over your existing systems

You don't have to rip out your landscape. traqx can run processes directly or layer over existing systems such as SAP, eQMS or SharePoint. The right depth depends on how your team works today — not on your company size.

Run under control: Generate. Verify. Monitor.

EU-hosted. No model training on your data. Human approval stays mandatory. AI drafts, your team reviews and approves — every decision stays with accountable people, with name, rationale and history.

No system switch

Replace nothing. Make it verifiable.

No system switch — start in the prioritised use case

Your SOPs, your templates, your regulatory context

Standalone or over your existing systems — you choose the depth

One process is enough to see whether traqx fits your regulated environment.

Built for GxP-regulated work.

Human pharmaBiotechAnimal healthAPICDMO/CRO

Whatever your sub-sector: if your work falls under GMP, GLP, GCP or GDP, traqx operates inside your regulatory context.

For GMP, GLP, GCP and GDP. EU-hosted. No model training on your data.

Use Cases

Start where the pressure is greatest.

CSV

Computer System Validation

Validation documents, traceability and review logic from a controlled, verifiable source base — risk-based, along your SOPs and templates.

View →

SOP management

Revise & standardise

Revise SOPs, standardise them and make them review-ready with source references — instead of a fifth review round.

View →

Audit readiness

Prepare before it gets tight

Structure gaps, evidence and preparation packages before the inspection sets the pace. Audit readiness isn't built the evening before the inspection.

View →

View all use cases →

The first step

From a use case to living data.

Not the big system switch — the entry in the prioritised use case. Your as-is process is the starting point toward fully digital, provable GxP compliance: living data instead of evidence hunted down right before the audit. Start small and controlled — and build out step by step toward a modern, scalable GxP way of working that you can show internally.

Insights

Solid knowledge from GxP practice.

No buzzword posts. Practice articles for project leads, IT owners and QA teams — from live validation projects.

All articles →

Pillar · GuideGuide

Regulatory frame, an honest map, five control principles, entry with one process.

Using AI in GxP — without giving up control

Is AI allowed in GxP? Long answered — the question is how controlled. The practical guide: draft Annex 22, GAMP 5, FDA CSA and the five principles that keep every result evidenced.

Reading time ~12 min · Read now

Pillar · KnowledgeAnnex 22

For the first time, a dedicated GMP annex for AI: scope, requirements, preparation.

EU GMP Annex 22: what the first AI annex means for your GxP practice

Static models, human oversight, independent test data, explainability: what the draft requires — and how to prepare today.

Reading time ~10 min · Read now

Pillar · Knowledge2nd Edition

From the rigid V-model to modular lifecycle practice

GAMP 5 2nd Edition: What CSV now needs

The Second Edition modernizes CSV: critical thinking, agile lifecycles, cloud and AI. What you need to adjust — and what not.

Reading time ~12 min · Read now

Newsletter

Monthly GxP insights by email

Practice-depth on CSV, audit-readiness and AI governance — no spam, unsubscribe in one click.

Common questions

Common questions about traqx

What is traqx?

traqx is an AI-native GxP compliance platform for regulated life-sciences teams in pharma, biotech and medtech. AI drafts SOPs, CSV documentation and audit preparation with source binding — your team reviews and approves (Generate · Verify · Monitor). Sources, versions and the audit trail stay connected throughout.

Who is traqx for?

For quality, validation and compliance leaders in regulated life-sciences companies — from mid-sized firms to global organisations. The entry is deliberately small: traqx Workspace starts with one team and one real GxP process; traqx Suite runs the complete GxP lifecycle.

How does traqx make sure AI results are evidenced?

Through the trust architecture: every regulatory statement ends on a clickable source (source binding), an AI suggestion remains a suggestion until approval (ghost values), every approval carries a name (human-in-the-loop) — and the audit trail documents the entire path.

Do we have to replace our existing systems?

No. traqx runs as a standalone GxP platform or connected to your existing system landscape — depending on your architecture, not your company size. There is no forced system switch.

Where is our data processed?

EU-hosted and GDPR-compliant. Your data is not used to train AI models — it stays your data, in your regulatory context.

What does traqx cost?

traqx Workspace starts at around €200 per licence per month — one team, one source space, one real GxP process. traqx Suite is scoped to your lifecycle in conversation. The fastest way to assess fit is the 30-minute live demo.

Live demo · 30 minutes · on your use case

See traqx live on your process.

No slide show — the real workflow on a real GxP example: source, draft, citation, approval.

First value: you see on a real example how an evidenced draft is created — and can judge whether it holds up in your house.

Step 01

Live demo

30 minutes, bookable directly — the workflow on a real example, gladly on your use case.

Step 02

Workspace entry

One team, one source space, one real process — from ~€200 / licence / month, without a major IT project.

Step 03

Suite expansion

Once the entry holds up: SOPs, validation, qualification and audit preparation in one guided working logic — scope discussed in conversation.

Book a live demo →

Pick a slot directly — 30 minutes, no form.

Check your use case →

Three keywords are enough — we reply with a concrete next step.

Read the FAQ →

No sales pitch — a short, concrete conversation about your use case. What we look at together stays yours — even if you say no afterwards. EU-hosted, no model training on your data, your team keeps content authority.

We take a full 30 minutes per demo — slots in order of arrival.