traqx

Workspace · one team, one source space, one process

The AI-native workspace for your first GxP process.

Your team works with its own sources and controlled drafts — with full content authority: you check every draft via the citation, without tearing out existing systems.

  • Answers with a source, not gut feeling.
  • Draft, source check and content check in one controlled flow.
  • Ready to start without a major IT project.

EU-hosted · no model training · you keep content authority

Evidenced with a sourceContent-checkedEU-hostedNo model training

A controlled GxP workspace, not a chatbotsource-bound · QA-decided

WORKSPACE · EVIDENCE DESK GENERATE · VERIFY · MONITOR SOURCES SOP-CSV-0012QM-DOC-204Annex 11 Map EVIDENCE LINE SOURCE-BOUND DRAFT “This SOP change is based on …” SOP-CSV-0012§4.2anchor found no anchor in poolunverified SOURCE CHECK binary · non-AI QA-GATE human decides AcceptReject reject with reasonno auto-release AUDIT-TRAIL who · when · review documented · rationale captured · §4.2 linked

Drafts are generated only from your approved sources – a closed, controlled space.

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

What the Workspace delivers

The fastest way out of the validation backlog.

The Workspace is for teams who don't want to understand traqx in theory first. Load the relevant sources, check a real question, have a draft created and see whether the answer is review-ready enough for your day-to-day work.

01 · Citation & source binding

Sources before phrasing

Answers emerge from approved sources, not from gut feeling. Every regulatory statement ends on a clickable source from your pool.

02 · Human-in-the-Loop

Authority, not autopilot

You keep content authority over every draft. The suggestion is built from sources and sits visibly alongside — you check it on its merits via the citation; nothing unverified is presented as truth.

03 · Deterministic check

Binary source check

A source reference holds or fails — no invented score. A deterministic check marks what does not hold as unverified, instead of presenting it as truth.

04 · Generate · Verify · Monitor

Your own rules first

Tenant SOPs, templates and policies take precedence over generic knowledge. The AI drafts from your rule set — conflicts between sources are made visible.

05 · Ghost Values

No model training

Customer data is not used to train models. EU-hosted, with your industry and company context — and a traceable audit trail.

The Agent Library

Five pre-configured agents for the most common GxP tasks.

Pre-configured working profiles from day one — each with a fixed answer structure and source binding in every section. You keep content authority and check every section via the citation. Click through them.

Compliance-Agent

Answers GxP compliance questions with precedence for tenant SOPs and approved sources. QA teams reach a robust assessment faster and see immediately where an answer is solid, limited or not sufficiently evidenced.

Typical requests
Classify FDA, EMA, ICH, GAMP, Annex 11 or 21 CFR Part 11 questions
Compare an internal SOP against the regulatory expectation
Prepare a reasoned QA decision with sources

Audit-Agent

Supports preparation for FDA, EMA or notified-body inspections. Audit preparation becomes more focused: teams waste less time on generic preparation and see earlier where evidence is missing.

Typical requests
Hotspot analysis by known finding patterns
Map SOPs, artefacts and evidence against the audit scope
Preparation list with gaps, owners and next steps

Grenze The agent does not declare audit readiness and does not guarantee an inspection outcome.

Validation-Agent

Supports risk-based validation work to GAMP / CSA logic. Validation leads gain a consistent baseline framework and reduce over- or under-validation through visible rationale.

Typical requests
Prepare GAMP categorisation and validation strategy
Structure URS, FS, DS/CS, IQ, OQ, PQ and reports
Derive risk-based test approaches from sources and templates

Grenze The agent does not produce executable tests without human review and no final validation decision.

SOP-Agent

Drafts, revises and harmonises SOPs along existing templates, terminology and conventions. SOP reviews start from a cleaner state: teams see faster where content, role logic or references do not hold up.

Typical requests
Update existing SOPs
Create new SOP drafts from approved inputs
Flag missing references, roles or form links

Grenze The agent does not invent SOP numbers, form IDs or references. Missing references are flagged.

Reviewer-Agent

Reviews GxP documents before the QA review for compliance, quality and consistency risks. Teams catch gaps earlier, before they cost time and trust in the formal review.

Typical requests
Review URS, FS, DS/CS, IQ/OQ/PQ, plans, reports and SOPs
Separate findings into compliance and quality
Structure risks as critical, major or minor

Grenze The agent can prepare a sign-off recommendation, but cannot grant approval.

Every agent answers in a fixed section structure, with inline citations in every section — the disclaimer is mandatory as the last line, never skippable.

Your own agents

Additional agents for recurring GxP tasks.

When your team regularly handles the same GxP questions, document types or review patterns, additional agents can be configured along your sources and rules.

Supplier evaluation

Check documents against defined qualification criteria, flag gaps, prepare follow-up questions.

Pseudo-code review

Check technical specifications, configuration logic or pseudo-code against validation requirements.

Email review

Check external communication for GxP relevance, commitments, unclear responsibilities and missing source references.

  • RAG with clickable citation — no answer without a source, even with your own agent.
  • Deterministic source check — invented citations fail as unverified.
  • GDPR-compliant, EU-hosted, with your industry and company context — no model training on your data.

What you can do today

One question carries almost every GxP task: “What changes about X when Y happens?”

Today, on your own material. The Workspace carries that question source-bound through your assigned documents and returns a checked first draft — you check it via the citation and move it into your own system. Five fields, well beyond the meeting minutes.

Cluster A

Change & impact analysis

“What changes about a URS or SOP when the process or a change changes?” The right GxP agent works through the affected document set and lays out a source-bound candidate list of the affected passages — every requirement, every section with an inline citation to the triggering point. Cross-document impact instead of line-by-line handwork after every workshop.

Cluster B

Audit preparation

Which assigned documents are affected by an audit on topic X? The Audit agent delivers the source-backed scope candidate list — and derives a hypothesis-based mock-audit question catalogue from your uploaded PIC/S sources and FDA Warning Letters, each question cited to the assigned clause.

Cluster C

Draft & specification

The Workspace drafts URS, Functional Spec and SOP drafts along your templates and policies — from the assigned rule sets it knows how a URS has to look at your house. Every paragraph cited, unverified flags what does not hold: writing becomes checking. Only the finished result is moved into your own system by hand.

Cluster D

Vendor & supplier comparison

Vendor proposals against your SOPs, policies and URS: the agent lays out matches, gaps and contradictions source-backed side by side and, on conflict, presents both passages verbatim. The “fits best” call is made by the human.

Cluster E

Team standard & your own agents

Share proven workbooks and custom agents: same sources, same agent, same method. One senior's approach becomes an evidenceable team standard, scalable across colleagues and sites.

Every use case delivers a first draft or a candidate list that you check on its merits via the citation — source-dependent, without guaranteed completeness and without any autonomous decision.

Honest about maturity

What runs today — and what is in preparation.

We label what is not yet finished, instead of presenting it as available today.

Live today

Your own rule sets

Your own industry guides

RAG citation

Binary deterministic source check

GDPR / EU hosting

No model training

Content authority & source check

In preparation

in preparation Excel outputs

in preparation Native Word creation

in preparation Self-service licensing

“In preparation” means: not yet in production. Until then we set up access together with you.

In comparison

Familiar like an AI workspace — built for regulated work.

What the source-checked difference is, row by row.

traqx WorkspaceGoogle NotebookLMChatGPT / Claude.aiMicrosoft CopiloteQMS (Veeva / MasterControl)
Source binding / Citation ✓ Inline, from your pool✓ Citations✗ none enforcedPartly — M365, no GxP scope✗ Record entry, no co-author
Deterministic source-reference check ✓ Anchor check (non-AI)
GxP role agents ✓ 5 + custom✗ no co-author
GxP domain knowledge (SOP hierarchy, conflict) Partly — workflow, no AI layer
Multi-model ✓ Opus/Sonnet/GPT/Gemini/Mistral✗ Gemini only✗ single-vendorPartly — primarily OpenAI
Audit-Trail per AI call ✓ Prompt, retrieval, model, providerPartly — IT logs✓ Record level
Formal approval workflow ✗ not in Workspace✓ Part-11 e-sign
EU region / no training ✓ EU region · no model training✗ US, tier-dependentPartly — Enterprise tierPartly — M365-dependent✓ established residency options

No single row is the moat — the combination on one Agent surface is: source-checked GxP generation right where the draft emerges. Horizontal tools have the surface without the control; the eQMS has the control, but no AI co-author.

EU region and no model training aren't an add-on — they're the basis of every Workspace licence; nothing ships without it.

Common question

Do I have to validate traqx myself?

What traqx delivers

Documentation to support your own validation, a deterministic source check, a traceable audit trail and EU hosting — without model training on your data.

What stays with you

The final validation and release in your own QMS remains your responsibility. traqx provides the basis but makes no regulatory decision for you.

Terms

One licence, clearly costed.

traqx Workspace · pro Lizenz

from approx. €200 / licence / month

The Workspace starts at approx. €200 per licence and month. Validation and implementation packages are agreed separately depending on scope.

Designed for audit traceability: source binding, deterministic source check and audit trail support your own validation. Validation and implementation packages are agreed separately depending on scope.

Start with Workspace
One seat · without an implementation project · EU-hosted

Start small, 
decide cleanly.

The Workspace takes the fear out of change: no full migration, no months-long programme, no flying blind. A limited process shows whether traqx fits the way your team works — before you decide on Suite, rollout or integration.

No model training on your data. Deletion of the source space can be governed contractually. Content authority stays with your team.