traqx

Trust · provable for QA, IT and business

Trust is built in the flow of work.

traqx shows which source, which version and which approval sits behind an AI-assisted decision — before it enters the process.

  • CSV expertise from GxP practice
  • AI drafts, humans approve
  • Data and model boundaries visible

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

The full platform

QA sees review, approval and evidence.IT sees data and model boundaries.Business sees controlled speed.
GenerateAI creates a draft — source-bound and marked as a suggestion.
VerifyYou review at item level and approve with your name.
MonitorThe audit trail records who did what, when and on what basis.

What QA, IT and business need to see

Trust is not a claim. Trust is a way of working.

traqx ties AI support to sources, roles, reviews and approvals. So it stays visible where a suggestion comes from, who reviewed it, which version is affected and which decision resulted from it. That is the difference between AI text and regulated GxP work. traqx addresses all three perspectives through the same mechanism: AI drafts, the human reviews, the human approves, the audit trail stays intact.

01

QA sees

Approval and evidence logic. Every suggestion is bound to a source; every approval carries a name and a version.

02

IT sees

Clear data and model boundaries. EU-hosted, no model training on your data, no data leaving the agreed scope.

03

Business sees

Speed that is not paid for later in review. Controlled pace instead of correction loops before the audit.

Built by CSV experts: Founded by CSV experts with 15+ years of domain expertise. traqx is born not from AI hype but from GxP practice — from the experience that inspectors do not ask for polished drafts, but for evidence, versions, accountability and traceable decisions.

The traqx core principles

Six rules we let ourselves be measured by.

Sources first. AI stays a suggestion. The human decides. The audit trail stays. These principles are not marketing — they are the conditions under which AI is permissible in regulated GxP work at all. Click through.

Sources first

Approved SOPs, templates, policies and guides take priority. traqx suggests nothing that is not bound to your knowledge base and a concrete source.

GenerateEvery regulatory statement ends on a clickable source.
GenerateYour approved documents beat any generic model knowledge.
GenerateA source outside the approved pool is marked as unverified — not output as an answer.

AI stays a suggestion — the human decides

GxP decisions are not approved automatically. Every AI content item is marked as a suggestion until approval. Only your decision turns the suggestion into evidenced state.

VerifyItem-level approval — signed with your name.
VerifyRejecting requires a reason; nothing is adopted silently.
VerifyAI share and your edits stay distinguishable in the trail.

Binary source check

A source reference holds or fails. There is no deterministic score suggesting an „87% certainty“ that no one can defend in an audit. Passed or not passed — and that is traceable.

VerifyPassed or not passed — no soft confidence measure.
VerifyA failed reference blocks approval instead of diluting it.
VerifyThe check logic is explainable, not statistically hidden.

Ghost Values — uncertain values stay visible

Uncertain or missing values are not inserted silently but marked visibly. Where data is missing, you see a gap — not a plausibly invented placeholder that later turns out to be a finding.

VerifyMissing values are marked as a gap, not plausibly filled.
VerifyUncertain values carry a visible flag until clarified.
VerifyYou decide whether a gap is a blocker — not the model.

Audit trail

Changes, sources, approvals and open points stay traceable. The trail arises while working, not at year-end: who, what, when, on what basis, AI-suggested or human.

MonitorWho, what, when, on what basis — recorded immutably.
MonitorBuilt for 21 CFR Part 11 and ALCOA+ — evidenced, not eloquent.
MonitorOpen points stay visible until they are closed.

Data and hosting boundaries

EU-hosted. No model training on customer data. Your documents stay your documents — they do not improve any external model and do not leave the agreed scope.

MonitorEU-hosted — GDPR-compliant, Made in Germany.
MonitorNo model training on your data.
MonitorHuman approval stays mandatory — that, too, is a boundary.

These principles describe how traqx is built — no audit numbers or customer results. Concrete evidence arises on your own document in your own first process.

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

Trust pack for internal review

What makes your decision internally defensible.

For internal decisions, the relevant information is provided in a structured way: data protection, model training, hosting, deletion, subprocessors, security status and validation approach. Where evidence is not yet final, this is clearly marked — no logos, no reference claims, no disguised customer stories.

Automate GxP approvals — decisions stay with the humanDeliberately not
Claim sources without evidence — every statement is source-boundDeliberately not
Trust score instead of a check — source verification is binaryDeliberately not
Fill gaps silently — missing values are marked as a Ghost ValueDeliberately not
EU hosting · no model training on your dataCommitted
Immutable audit trail — who, what, when, on what basisCommitted
Structurally committedDeliberately not automated

Formal certifications and a dedicated trust center are in preparation; the status will follow once it is reliable.

Test it yourself

The proof is not on this page, but on your document.

Trust is not decided on a page but on your own document. We test against a real process: one system or process, one standard, one clear scope. You judge on your material whether source binding, review logic and audit trail are reliable for your process — and whether they let you lead your department more calmly through the next audit. We set the success criteria together in writing beforehand: a test you defined yourself, you cannot lose. The documented assessment is yours — even if you say no afterwards. And we delete your source space after the test on request, demonstrably.

EU-hosted. No model training on your data. Human approval stays mandatory.