GxP Compliance Intelligence · for Quality, Validation & Digitalisation

Versions, sources, approvals — under control.

traqx consolidates regulated work on an AI-native architecture: documents stay usable — data, versions and approvals are kept from sources and approved by people. No system switch.

Every approval runs under control — AI drafts, your team checks, your team approves.
Data, versions and evidence stay connected, versioned and review-ready.
EU-hosted, data-sovereign — your regulated work never leaves your control.

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Generate · Verify · Monitor

On the Workspace architectureEU-hostedHuman approval stays mandatory

01 · Data, not documentsDocuments stay. The data beneath them comes alive.

One approval runs through whole document chains and across several processes — and at every handover it gets lost which version, which source and which decision sits behind it.

Existing systems

No system switch. No change programme.

traqx does not replace Veeva, MasterControl, SAP or SharePoint. The Suite is AI-native and works on its own or connected to your existing systems — the integration sits in the architecture, not in a migration project. Your templates, your SOPs, your formats stay.

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

Data, not documents

From documents to guided GxP processes.

The Suite is for organisations that do not want to handle every GxP topic in isolation. SOPs, validation, qualification, reviews, approvals and evidence belong in one shared working logic. traqx runs this logic AI-native: faster in the draft, clearer in the review, traceable in the approval.

Template Engine · live in the Workspace today

Templates stay.
Data lives.

Your templates, SOPs and formats stay in use unchanged. What changes: traqx reads the sources behind the document and runs the content as connected, versioned data.

A requirement can be traced back to its source, a change carries through traceably — instead of getting lost again in the next copy. That produces review-ready drafts instead of empty forms, and the evidence chain stands before anyone asks for it.

This data architecture already runs in the Workspace today. The Suite carries it across the entire GxP lifecycle — we set the concrete lifecycle scope in the call.

The first step to fully digital GxP compliance: not managing documents, but running living, provable data.

Guided sources

Guided sources. Provable drafts.

Every draft is created risk-based on a guided source hierarchy: your SOPs first, then recognised industry guidance (GAMP 5, Annex 11, 21 CFR Part 11), then the project context. Where two sources contradict, traqx decides nothing silently — the passage is brought up for review with both clauses. Every statement is source-based and provable. Nothing is created in the dark, nothing runs through automatically: AI drafts, your team checks, your team approves.

Knowledge

Knowledge Management — the three layers (System · Tenant · Project); the precedence rule you set decides.

Template Engine

Template Engine — your structured template data: every block linked and queryable, every connection evidenced.

Agent Library

Agent Library — the role-based agents that draft and the Reviewer that checks; every suggestion stays source-bound.

Project Workspace

Project Workspace — the project context: requirement, risk assessment, the scope this decision belongs to.

Workflow Mgmt

Workflow Management — the approval path: who signs, what changed, the audit-tight artifact.

Source hierarchy · live in the Workspace today

The right knowledge with the right function.

At any time. Every decision provable.

Not a static stack but a living network: the three knowledge layers, your template data, the role-based agents, the project context — merged situationally. In an audit, what counts is not that an AI suggested something, but that you can trace every line back to its source.

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 architecture merges knowledge and agentic tools in real time — click a building block to see what it pulls.

This guided architecture — source hierarchy, template data and role-based agents — already runs in the Workspace today. The Suite carries it across the entire lifecycle — depending on your process scope.

Product proof · New version history

Classic compliance, modernly delivered.

traqx takes no shortcut around GxP. The platform modernises work within the framework: sources stay visible, versions carry reason and change, and decisions are made and documented by people.

URS-CSV-0042 · Validation Report · §4.2 Data Integrity DEMO

Current · v3 approved · D. Herrmann · 2026

The system versions every change to a validated dataset with timestamp and user ID.

AI suggestion · pending Source check PASSED

The system versions every change to a validated dataset with timestamp, user ID and rationale — immutable in the audit trail.SOP-CSV-0012 §4.2

Rejecting requires a reason

Reason for rejection (required)

DEMO-URS-0042 · Illustrative example — no customer data.

This mechanism — approval and history at the item/data level, with a mandatory reason and distinguishable AI/human origin — already runs in the Workspace today. The seamless history across the entire lifecycle is made concrete in the Suite scope.

Modern approval workflows

Workflows that guide approvals.

Modern approval workflows instead of email loops and a fifth review round. Roles, sequence and approval basis are defined — every decision is approved at the data level, versioned and logged review-ready. You see at any time which version is the current one, who approved on what basis and where a case stands right now. Audit readiness arises in the running process — not the evening before the inspection.

01 · Delta review

Review only the change

Reviewers check the delta, not the whole document every time — the version history knows what changed and why.

02 · E-Signature

Legally compliant, frozen

Legally compliant electronic signature with a frozen PDF as an audit-tight artifact — identity, signing intent, data linkage.

03 · Availability

Deputy & leave handling

Automatic deputy and leave handling — approvals keep moving even when someone is away.

What the platform already does today: item-level approval with a mandatory reason, an AI/human-distinguishable audit trail, human approval as a mandatory step — live in the Workspace.

suite scope These approval cycles across the entire GxP lifecycle — from data object to frozen artifact — are scoped and implemented for the specific process in the call.

Role-based agent collaboration

Role-based collaboration at the standard.

Not a tool you have to operate, but dedicated agents along the roles in a review: author agents draft, a Reviewer agent checks before the QA review — and the human in QA/QP gives binding approval. The standard lives in the agent, not just in the senior's head — every suggestion stays source-bound.

Author agents

Compliance, Validation and SOP agents draft along your approved sources, templates and conventions — with precedence for your tenant SOPs. Every section carries its source; missing references are flagged, not invented.

liveCompliance agent — regulatory work with precedence for your SOPs, evidenced

liveValidation agent — risk-based, GAMP/CSA logic

liveSOP agent — procedures along your templates and terms

scope-dependent The author agents already run in the Workspace today. Their collaboration across the entire lifecycle is part of the Suite scope.

Reviewer agent

A dedicated Reviewer agent checks GxP documents BEFORE the QA review for compliance, quality and consistency risks — and discloses what it measured against. It catches gaps earlier, before they cost time and trust in the formal review.

liveFindings split into compliance and quality

liveRisks structured as Critical, Major or Minor

livePrepares a sign-off recommendation — never grants approval

scope-dependent The Reviewer agent already runs in the Workspace today: “checked, never approved.” The review collaboration across the entire lifecycle belongs in the Suite scope.

QA / QP

At the end stands the human: QA and QP give binding approval. No mode in which a document is validated without human approval — the agent can prepare a recommendation, never replace the approval.

liveItem-level approval — accepted or rejected with a reason

liveAI share and human edits stay distinguishable in the trail

liveHuman approval stays mandatory

scope-dependent Item-level approval and distinguishable origin already run in the Workspace today. The binding role collaboration across the entire lifecycle is set in the Suite scope.

GDPR-compliant, EU-hosted, with your industry and company context — no model training on your data. Every agent stays within the frame you set; human approval stays mandatory.

Workspace and Suite

Where the Suite takes over.

“Platform” is the roof. Workspace and Suite are two entries underneath — the same data architecture, once as an immediate Workspace start, once as a Suite scope across several processes.

Data governance at the block/item levelSuite · scope

Data-level approvals with human approvalSuite · scope

New version history (rationale & AI/human origin)Suite · scope

Modern approval workflows (delta review, e-sig)Suite · scope

Role-based agent collaboration across the lifecycleSuite · scope

Suite · scope — set in the call; the foundation runs in the Workspace today

Whoever wants to start today begins in the Workspace — on the same data architecture the Suite builds on across the entire lifecycle.

Honest about maturity

Solid today.
Lifecycle in scope.

We clearly separate the Workspace foundation from the concrete Suite scope. The mechanisms are live in the Workspace; lifecycle expansion is set for each process landscape.

Solid today — live in the Workspace

✓ Template Engine — data, not documents; every block a data object

✓ Item-/block-level approval with a mandatory reason (Ghost Values)

✓ Distinguishable AI/human origin in the audit trail

✓ Role-based agents — author agents & Reviewer „checked, never approved“

✓ Source binding, deterministic source check, EU hosting

Suite scope — made concrete in the call

suite scope New version history across the entire lifecycle

suite scope Modern approval workflows with delta review & E-Signature

suite scope Role-based agent collaboration across the whole procedure

Suite scope means: we clarify process, roles, data objects, approvals and system boundaries before implementation. The entry point stays concrete: one use case, a Workspace start or a Suite scope for your process landscape.

Digitalisation that QA carries with you.

An AI initiative you can show the board — and that does not die in the Quality review. traqx modernises regulated work into living, provable data without giving up control: human approval stays mandatory, every statement stays source-based. Scalable across GxP domains, starting with one prioritised use case.

Suite scope · foundation in the Workspace today · EU-hosted · human approval stays mandatory

Scope your use case
review-ready.

In the conversation it becomes concrete which workflows come first, which roles are involved, which systems are connected and what approvals look like. The goal is not a demo promise but a dependable platform path for your quality team. We clarify which process belongs in the Suite scope first.