AI-NATIVE GxP COMPLIANCE SOFTWARE
Reliable GxP work. Created faster. Easier to review.
traqx handles research, drafting, document updates and traceability work. Every proposal shows its source, status and open points — your experts review and decide.
CONNECTED PRODUCT FLOW · 50 s
The work is prepared. The decision is not.
- Dashboard: A team tests traqx on one real project without replacing existing systems.
- Ghost value: Ghost values become document content only when a subject-matter expert accepts or rejects them.
- Cited answer: Every citation is checked deterministically against the source space. It passes or fails.
- Your source space: Answers come from SOPs, policies, templates and approved GxP knowledge.
- Meeting → Word: The agent scopes the impact and returns the URS as a .docx with tracked changes plus source and rationale comments.
traqx · evidence path
Source → check → ghost value → meeting impact → Word review
AI work you can verify.
See in 50 seconds how traqx checks sources, prepares changes and hands over a review-ready Word file.
traqx.
Prepared by traqx. Ready for human review.
From meeting decision to review-ready Word file — with tracked changes, sources and rationales.
01Human plans the task→
02traqx prepares a reviewable result→
03Human reviews
Your experts set the direction. traqx prepares GxP work for review.
SIX PRESSURES IN DAILY GxP WORK
What slows your experts down today.
01 ResearchRelevant sources are spread across systems.
Your team first has to bring affected documents, relationships, laws and regulations together before the actual assessment can begin.
02 Document updatesThe draft is ready. The reliable reference is missing.
Updates are drafted manually; sources and technical rationales then have to be found again and added afterwards.
03 DependenciesOne change affects further documents and tests.
Requirements, risks, SOPs, tests and versions have to be checked for impact and painstakingly reconciled.
04 Knowledge transferNew colleagues need knowledge held by only a few experts.
Experienced specialists repeatedly explain regulatory foundations and internal processes in individual cases — in addition to their actual work.
05 Capacity pressureUrgent GxP tasks compete for the same experts.
Research, updates and reviews accumulate, yet the groundwork cannot be delegated to an unreliable tool.
06 Missing contextGeneric tools know neither your SOPs nor your processes.
Without controlled sources and project context, answers remain generic; your team has to review and rebuild them.
THE TRAQX TRUST LAYER
Four controls turn AI output into reviewable work.
01 / 04
INDUSTRIES & WORK CASES
A trust system for your daily GxP work.
traqx applies the same controlled working logic across your processes — from CSV and SOPs to Pharma, MedTech or CRO.
Explore all industries →
CSVSOPsAuditsQualificationValidationChange ControlSuppliers
traqx
AI-NATIVE GxP PLATFORM
traqx connects controlled sources, documents and decisions in one reviewable work context.
- Less manual effort
- Shorter cycle times
- Traceable decisions
SECURITY · CONTROL · EVIDENCE
Clear boundaries. Visible control.
Tenant, hosting, data use and provider evidence are defined explicitly for the agreed scope.
Inspect Trust Architecture01Data boundaryEU hosting within the agreed tenant and hosting scope
02Model boundaryNo model training on customer data
03Product controlSources, proposal status, human review and audit trail stay visible
04AWS provider evidenceProvider-side ISO 27001 certificates and SOC reports are available for suitable AWS services; they do not certify traqx
PRACTICAL KNOWLEDGE
Knowledge for the next GxP decision.
AI governance · GxP
GxP AI policy: what a workable AI use policy should control
From initial screening to data, human review and audit trail: ten building blocks, three decision lanes and a usable policy core for regulated teams.
Read article →FDA · Elsa 4.0 · HALOFDA Elsa 4.0 and HALO: what GxP companies need to know
Elsa 4.0 is already in use. We separate confirmed FDA facts from speculation and show how teams can prepare sources, human review and decisions for faster scrutiny.
Read article →GxP AI · Prompting10 GxP AI prompt patterns for controlled work
Ten complete work patterns for SOPs, CSV, audit preparation, CAPA and other GxP tasks — each with a source boundary, review question and explicit stop condition.
Read article →GxP · AI · Software
What is GxP AI software?
GxP AI software helps teams research, draft, update documents and maintain traceability — tied to the relevant GxP context. In traqx, it works from controlled sources. The source, review status, changes and open points remain visible before an expert reviews, corrects and adopts the work item. The technical decision remains human.
FAQ
Clear answers before the meeting.
What is traqx?
traqx is AI-native GxP compliance software. It prepares research, drafts, document updates and traceability in a controlled source space; experts review, correct and decide.
How does traqx keep results source-bound?
Every citation points to file and section and is checked deterministically against the controlled source space. The content still remains an AI proposal until an expert has reviewed it.
Does traqx replace our existing systems?
No. traqx starts with a defined work case and controlled context. Existing eQMS, repositories and templates remain leading where required; integrations and process scope are clarified separately.
How does traqx handle customer data?
traqx hosts customer data in the EU within the agreed tenant and hosting scope and does not use it to train AI models. Sources, proposal status, human review and the audit trail remain visible; specific security and validation requirements are clarified for the defined scope.
What is included in the licence?
traqx is licensed per user licence and month. Document-based use cases are included without a module surcharge; configuration and implementation depend on scope. We discuss the concrete offer in the intro call.
ONE CONCRETE WORK CASE
Make your next GxP work state reviewable.
In the 15-minute introductory call, we clarify your typical GxP work case and the right way to start free of charge. We share the system and strategy call afterwards when it is the right next step for your case.
Book a meeting & start free →15-minute introductory call · no preparation required · Brevo Meetings