traqx AI-Native GxP Compliance Platform
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For quality and validation leaders in pharma, biotech & medtech.

Audit-proof GxP compliance —
in days, not weeks.

You sign with your name — you need certainty. traqx makes every line above it verifiable, fully integrated into your company knowledge, policies and SOPs. Without switching systems.

Your team works with built-in senior expertise — and the knowledge stays in-house.

Request a pilot → traqx principles →
AI GeneratedHuman VerifiedAudit-ProofEU-hosted
Validation Report · URS-CSV-0042 Cited & verified
✓The system shall version every change to a validated record with timestamp, user ID and reason.SOP-CSV-0012 §4.2
✓Electronic signatures comply with subject identity, intent of signature and data linkage.21 CFR Part 11 §11.50
✓Risk classification follows the validated, risk-based GxP approach.GAMP 5 (2nd ed.)
Approved & signed · 2026D. Herrmann ◍ Human-approved
Test Protocol · changes proposed AI draft · your review
+ addedCofA is not generated while RES-OOS-001 is in “Rejected” status with an open incident.
~ revisedAudit trail shows the QC Reviewer REJECT event with e-signature record and reason.
~ revisedNo gaps in the audit chain — timestamp and user attribution on every event.
3 added · 6 revised ✕ Reject ✓ Accept
Answer · fully traceable Sources verified
Key observation · 2025

Inadequate system controls enable the data-integrity finding — FDA remediation addresses both layers at once. A CAPA covering only one is deemed inadequate.

Every citation is deterministically verified — each points to a document actually retrieved for your question. The AI invents nothing.
● 37 sources ✓ 100% traceable

Validation is the start

Validation is the start.
Not the limit.

Most people meet traqx through validation — that's where the pressure is highest. But you own more: SOPs, deviations, change control, audit readiness, suppliers. Your entire GxP universe.

  • →That's what traqx is built for — not a validation tool, but a configurable GxP compliance platform that carries every one of your frameworks on one defensible foundation: three-layer knowledge architecture, living templates, user-guided AI. Without switching systems.

Validation is where you start. Your GxP universe is what traqx is built for.

Validation SOP Management Deviation / CAPA Change Control Audit Readiness Supplier Qual.

You know this moment

You know this moment.

Some of these aren't in any SOP. You know them anyway — because in the end, your name is on it.

01The review that never ends.

Fifth round, same URS. Three comment rounds later the document holds. Your evening doesn't.

02The inspection in six weeks.

Is every assessment of the last two years evidenced? A warning letter doesn't hit the system — it hits the name that signed off.

03The same SOP, three versions.

Site A on version 4, B on version 3. You reconcile versions instead of shaping quality.

04The backlog that never shrinks.

Every deviation pulls a CAPA, every CAPA an effectiveness check. You work it down — and never get ahead.

05The knowledge that walks out the door.

Validated cleanly — but the how lives in an external's head, not in your records.

None of this is your team's fault. It's that your compliance lives in documents that know nothing about each other — and the standard that holds them together lives only in your head.

What you won’t need

New compliance software usually means: migration, revalidation, budget battle. With traqx, that falls away.

System migration

✓traqx runs standalone, EU-hosted — or connects to Veeva, MasterControl, SAP, SharePoint. No move.

Revalidation

✓traqx works inside your existing validation lifecycle. Your methodology stays.

Template redesign

✓Your templates, your SOPs, your formats — 1:1. Word in, Word out.

Change management

✓Your team keeps working in the documents it knows. No format break.

Budget battle with Finance

✓No CAPEX for a system replacement, no multi-year rollout. Department-level approval is often enough.

traqx adds one intelligent layer to what you already have. That’s all.

One platform. One scaffold.

One platform. One agentic Brain.
Five building blocks.

Not a pile of tools. At the center, the traqx agentic Brain — it connects your knowledge with agentic tools and makes every decision defensible. Around it, five building blocks that carry every GxP framework you need.

The center · agentic Brain

The right knowledge with the right function.

At any time. Every decision defensible.

At the center of the platform, the Brain connects everything that belongs to a GxP decision — knowledge and agentic tools in real time. In the audit, what counts isn't that an AI suggested something, but that you can trace every line back to its source.

Not a static stack, but a living network: the three knowledge layers, your template data, the agents, the project context — assembled in the moment.

The AI suggests. You decide. No autopilot — a tool you steer. Every suggestion shows its origin; you check and approve. Or not.

How the Brain assembles a decision

The Brain assembles knowledge and agentic tools in real time — click a block to see what it pulls.

Building block 1

Knowledge Management

Three layers, one truth — the right knowledge at the right moment, never outside the boundary you set.

Compliance rarely fails for lack of knowledge, but for the wrong knowledge at the decisive moment. traqx separates it cleanly into three layers.

The precedence rule is yours to configure — not a model's gut feeling. The Brain moves only within that frame and shows which layer each suggestion comes from. Your tenant layer is isolated: your data doesn't flow into a shared knowledge base or into model training — even if a competitor uses the same platform.

System

System Knowledge

Industry standard, current daily: GAMP 5, Annex 11, 21 CFR Part 11, FDA warning letters, MHRA, data integrity. Applies to all tenants.
Tenant

Tenant Knowledge

Your world: policies, SOPs, templates, conventions, sub-frameworks (GBS, EWM, LIMS). Where your rule and the standard diverge, your rule applies.
Project

Project Knowledge

Local context: validation strategy, risk assessments, test scope. Dominates within the project.

Building block 2 · Template Engine

Templates stay.
Data comes alive.

Your team keeps working in the documents it knows. Underneath, every table and block becomes structured, audit-proof data.

No system switch — the most expensive part of any digitization. You keep your existing structure (policy → SOP → template). Even complex legacy documents — under your control, not blind.

The first step to fully digital GxP compliance: not a break with what you have — an upgrade of what you already built.

Building block 3 · Agent Library

Five agents from day one.
As many more as you define.

Not another tool to operate — a colleague that already knows the standard. Each agent is steered by the Brain, works within your SOPs and wording, every suggestion stays source-bound.

SOP Agent

Creates, maintains, versions SOPs along your conventions.

Validation Agent

Validation per GAMP 5, Annex 11, 21 CFR Part 11, from URS to test script.

Compliance Agent

Regulatory questions with evidence: every statement bound to its standard.

Audit Agent

Audit prep; surfaces unevidenced statements before an inspector asks.

Reviewer Agent

Checks structurally against your requirements and discloses what it measured against.

Configure a sixth.

On the same proven scaffold we configure further agents to your need — fast, because the foundation stands. You grow along your reality, not a product roadmap.

Building block 4 · Project Workspace

Every GxP project, one logic.

Validation, equipment qualification, cleanroom, process — every kind of GxP project follows the same logic: policy → SOP → templates, with roles, responsibilities and approval workflows. traqx runs them all in one project space.

SetupRolesStatusClosureChange Control
01Project Orchestration Agent

Guides the lifecycle: setup (validation plan, methodology, scope), roles and responsibilities, status and blockers, closure (Validation Summary Report → go-live) and change control after.

02Document Workspaces in the project

Each document its own linked workspace (URS, RA, SOP, test scripts), audit-proof and versioned.

03Across projects

Multi-site (template ↔ factory ↔ rollout) and cross-project traceability.

One project space for every discipline — instead of five tools no one keeps in sync.

Building block 5 · Workflow Management

Modern approval, no standstill.

Your approval and change flows — modern, traceable, without a bottleneck.

◆Modern approval cycles

Instead of rigid, linear signature chains.

◆Delta reviews

Reviewers check the change, not the whole document.

◆Legally compliant e-signature

With a frozen PDF as the audit-safe artifact.

◆Change control after go-live

Controlled, documented, risk-assessed.

◆Automatic deputy & vacation handling

Approvals keep moving even when someone is out.

Your processes stay yours. traqx maps them and makes every step defensible.

Your framework. Your processes.

Fully configurable.

You set the frame. traqx maps to it — not the other way around. Other tools force their workflows on you. traqx maps your actual or target process 1:1 — on the scaffold of the building blocks.

SOP Management — creation, maintenance, versioning (SOP Agent)In the platform · day one
Audit Readiness — every decision defensible; audit trail as architectureIn the platform · day one
Validation & Qualification (CSV) — URS to test script, GAMP 5 / Annex 11 / 21 CFR Part 11In the platform · entry use case
Workflow Management — your actual / target processes 1:1In the platform · configurable
Change Control — changes to the validated state controlled and documentedIn preparation · Q3 2026
Deviation & CAPA — flows along your SOPsConfigured on your framework
Supplier & Vendor QualificationConfigured on your framework
Equipment, Cleanroom & Process Qualification — same logic as CSVConfigured on your framework
In the platform — demonstrable todayConfigured on your framework — a capability, not a shelf moduleIn preparation — just before rollout

For configured disciplines the concrete flow takes shape with you in the project. No half-mapped QMS — a platform that carries each discipline on the same foundation. Validation is the entry, not the limit.

The signature method

Generate. Verify.
Monitor.

You sign at the end. traqx makes sure every line before that is defensible.

Step 01 · The AI surface

⟳ Generate

The AI drafts from your templates, SOPs and the knowledge architecture. Every item is marked as an AI suggestion until approval, and source-bound.

Step 02 · The human surface

✓ Verify

You check and approve, item-level. Only your decision turns a suggestion into defensible state. AI share and your edits stay distinguishable in the trail.

Step 03 · The audit surface

◍ Monitor

The audit trail emerges as you work, not at year-end: who, what, when, on what basis, AI-suggested or human. 21 CFR Part 11.

Verify · item-level0 / 3 approved
○The system shall version every change to a validated record with timestamp, user ID and reason.
SOP-CSV-0012 §4.2
○Electronic signatures comply with subject identity, intent of signature and data linkage.
21 CFR Part 11 §11.50
○Risk classification follows the validated, risk-based GxP approach.
GAMP 5 (2nd ed.)

Audit-proof means: defensible, traceable — and the human approves. Not "the AI does your compliance," but: your compliance, with evidence built in.

Your team gets better — not replaced

traqx is the experienced senior colleague that knows GAMP 5, Annex 11 and the patterns from FDA warning letters, and brings it into every task. The know-how barrier between junior and senior drops. Your team works with built-in senior expertise — and the knowledge stays in-house. The human stays at the center; traqx takes the research, not the responsibility.

Deployment: on your systems, not against them

Today: templates in, results 1:1 back — no integration needed, traqx runs standalone, EU-hosted. Roadmap: connectors as an intelligence layer over SharePoint, Documentum, Veeva, MasterControl, SAP (maturity per system stated openly). No forced migration — you keep your tools.

How traqx is different

Not a wrapper.
A defensible architecture.

01

Not a ChatGPT wrapper.

Generic models invent plausibly, without origin. traqx suggests nothing not bound to your knowledge base and a source.

02

Not a thin API layer.

The Brain orchestrates knowledge, templates, reviewer and agents in real time — the substance is in the architecture.

03

Not a replacement for your Veeva or MasterControl — a layer above it.

Your EQMS stays; traqx turns its documents into defensible, living data. If your vendor announces its own AI: traqx doesn't replace it, traqx lifts it to a level a workflow system can't reach.

04

Not an 18-month consulting engagement.

Templates taken over by ingest, not rebuilt by hand — your entry stands in days.

05

Not a rigid QMS tool.

We configure the platform to your framework, not your framework to the platform.

traqx is the configurable GxP compliance platform that works on your processes, not against them.

Your transformation with traqx

Choose your role. See what changes.

Not a promise — a before-and-after. Where you stand today, and where traqx takes you.

From twelve quality baselines to one.

Twelve sites, twelve documentation baselines, no shared yardstick.
One compliance truth across every site — the same standard, everywhere.
Knowledge retires — 25 years of experience walk out the door.
Knowledge lives in the system, not in heads. It stays when people leave.
Sleepless nights before the inspection.
A gapless audit trail that stands up for you. You show what you signed.
Quality depends on who wrote the document.
Consistent quality — regardless of the author’s experience level.

From AI experiment to flagship project.

Three AI pilots failed — no tool understands the regulatory side.
traqx runs. The first AI-generated document is approved, audit-proof.
The board asks: “Was AI in compliance the right priority?”
You show measurable speed in the quarterly review.
The innovation hub is seen as a playground without results.
You’re the internal model for “AI that works in pharma.”
QA blocks every initiative with “How do you validate the AI?”
QA is on board — audit trail and human-in-the-loop convince instead of blocking.

From bottleneck to supported expert.

120-page URS by hand — every change starts over.
URS draft in hours. You review and decide instead of starting from zero.
“GAMP 5 says… — but which clause?”
The sourced answer with a citation, in seconds. You approve.
The decisive knowledge sits in one person’s head.
The knowledge lives in the Knowledge Base — available to the whole team.
Every department reads the rule differently.
Consistent answers based on industry standards, not opinions.

From “every factory from scratch” to a scalable rollout.

Every site rollout = a complete new validation cycle.
Factory 2 in a fraction of the time — templates and knowledge are reused.
Budget runs over, the timeline slips.
Predictable timelines — the team works system-supported, without a constant consultant.
Dependent on the external consultant who’s never available when you need them.
Your team runs the validation independently, system-guided.
Validation is the gate the go-live waits behind.
Documentation emerges along the work — no downstream jam.

In mid-sized companies, buyer and user are often the same person. What convinces procurement — defensibility, no system switch, control — also carries the daily work.

This isn’t the distant future. It starts with one document. Request a pilot →

Why us

Built by people who wrote your URS — and stood behind it in the audit.

15+ years on your side of the table: writing URS, owning validations, standing before inspectors. traqx grew out of that — the diligence stays, the effort doesn't. What traqx generates, we would have signed without hesitation.

15+
years GxP / CSV
60
validated systems owned
0
critical findings in validations owned
Daniel Herrmann
Daniel Herrmann

CSV expert, 15+ years GxP compliance (incl. Boehringer Ingelheim, Johnson & Johnson).

Alexander Schrot
Alexander Schrot

16+ years enterprise software, architecture of scalable platforms.

Founded by CSV experts with 15+ years of domain expertise.

Trust, principles & the next step

Built to pass the inspection —
not the demo.

  • ◆21 CFR Part 11 audit trail — every action with timestamp, person, source and origin (AI or human). Not an after-the-fact log, but architecture.
  • ◆Human-in-the-loop by design — no mode in which a document is validated without human approval.
  • ◆When the AI gets it wrong — no AI content is defensible before you've approved it item-level; every suggestion carries its source. What can't be evidenced is marked unevidenced, not stated as fact.
  • ◆Your data stays yours — AWS Frankfurt, EU, Schrems-II-compliant, no model training on your data, tenant isolation.
  • ◆Standards — GAMP 5, EU GMP Annex 11/15, ALCOA+, 21 CFR Part 11.
  • ◆Vendor qualification — at pilot / commercial start: self-validation dossier, supplier audit package, contractually assured source-code escrow, continuity commitment.

traqx principles

  1. The AI suggests, the human decides. No autonomous compliance.
  2. Every statement carries its source. Defensible to the standard, not just articulate.
  3. Your frame, not ours. We map your framework — you configure the precedence rules.
  4. The audit trail is architecture, not a feature on top.
  5. No system switch. Your templates, your structure, your stack stay.
  6. Honest maturity. What's live is live; what we configure, we say so.

Frequently asked

Answered without
marketing filters.

How fast — and what does setup cost?

Entry through your templates (no migration, no rebuild) → days, not weeks, to the first defensible result. Alongside the license there's a one-time onboarding component; we define the scope transparently before you commit.

Who sets it up?

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

Global program, local adaptation?

Yes — global requirements, local SOPs and project decisions on three layers; you configure the precedence logic.

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 — a platform that carries every framework.

Is traqx itself validated?

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

Pricing?

Annual license + usage-based component + three tiers by size. Standard functions covered by the license — plannable without surprises.

What does IT / QA need to bring?

Your templates and SOPs, one contact each from quality and IT. SSO/LDAP optional. No infrastructure, no system swap.

Data protection & AI regulation?

AWS Frankfurt, EU, Schrems-II, no model training on your data. A specialist legal review found — as of now and for the scope described — that traqx does not fall under the EU AI Act high-risk classification.

Model updates?

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

And if traqx can't deliver?

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

Pilot programme · 8–12 weeks · 1 real use case

start with one document.
see the difference.

The first step toward fully digital GxP compliance.

We work with a deliberately limited number of pilot partners — to ensure quality and close collaboration. The discovery window is two weeks; after that, you make a clear decision for or against the pilot.

Step 01
Discovery window
Three structured meetings — Real-time demo · Deep walk-through on your use case · Terms & commitment.
Step 02
Pilot commitment
Scope fixed, contract signed — pilot scope locked before onboarding begins.
Step 03
Onboarding + live phase
First generated documents (URS, risk analysis) within 2–3 weeks. Full pilot 8–12 weeks.

Send us three keywords — which system or process, which standard, what's slowing you down — by email. We get back to you within 24 hours and arrange a first call. VaaS conditions for pilot partners are structured so that department-level approval is typically sufficient.

Apply for the pilot — pilot@traqx.io → Read the FAQ →

No sales pitch — a 30-minute conversation where we look at your concrete use case and assess whether a pilot fits.

Deliberately limited pilot partners · two-week discovery · reply within 24 hours