Create
New GxP documents from your sources: draft, evidence, Word export.
Reliable GxP work.
Created faster. Easier to review.
Every sentence shows its source — from your SOPs, templates and the regulations that apply to you. Your team reviews and decides.
No credit card · EU-hosted · DPA available before registration
Grown out of real GxP consulting practice — including projects for Boehringer Ingelheim and Johnson & Johnson.
- 17 years
- of GxP consulting
- 30,000
- consulting hours
- 60+
- consulting clients
SAMPLE REVIEW VERSION
This is what the result looks like: an evidenced, exportable review version.
Every statement carries its source and status — passed / not passed. Open references stay visible, and the export arrives as a Word document with evidence.
REGULATIONS AND SOURCES
Your regulations. Extend them freely.
traqx works within the GxP reference frame — among others EU GMP Annex 11, 21 CFR Part 11 and FDA CSA. You bring your licensed works, SOPs, policies and templates; every further rule is added on top.
- FDA Warning LettersWhat regulators actually cite
- EU GMP Annex 11Computerised systems
- 21 CFR Part 11Electronic records and signatures
- ICH Q9Quality risk management
- FDA CSAComputer software assurance
- Data integrityMHRA, PIC/S and WHO as reference frame
- Your SOPs and policiesYour house standard for how work is done
- Everything elseAny additional regulation you bring in
New rules are understood, not just stored.
You extend the source space yourself at any time. traqx processes a newly added rule, maps it to your documents and applies it in the next draft.
Your SOPs outrank the regulations.
If your SOP answers a question, traqx follows your SOP — the regulation supplies the rationale. Where the two disagree, traqx surfaces the conflict and asks which source to follow. Never decided silently.
THE TWO MOST COMMON OBJECTIONS
“We are on paper.” “Our data isn’t AI-ready yet.”
We hear both almost every week. Both have the same answer: you don’t need a data programme. You need one process and your approved documents.
MYTH
Data lake first, AI second.
HOW IT ACTUALLY WORKS
Data has to be “AI-ready” when you train your own model. You are not doing that — almost nobody is. What you need, you already have: approved documents. Word is enough. A paper approval is enough.
Five steps, this week
Take one process. Not ten. One.
Collect the approved documents for it: policy, SOP, template.
Make those documents the only source space — not the internet, not the model’s own knowledge.
Have every statement checked against those sources: evidenced or not evidenced. There are no other states.
Everything unevidenced goes to review. Approval stays with a human.
Early traqx customers work exactly like this: fully document-based, with Word. They steer their data quality with traqx — not beforehand for traqx.
And the quality of your documents is already there. Otherwise you would not be allowed to produce.
Start free now →
Registration → 15-minute intro call → personal activation
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 difference from generic AI in one sentence: traqx works from the sources you release — and shows what is evidenced and what is not.
ON YOUR CASE — NOT ON OUR SLIDES
Evaluate traqx on a new or an existing document.
Bring a specific document type and released sources. traqx produces an evidenced, exportable review version from them — or marks the deviations in an existing document against the sources you release. Your experts then decide whether it holds up professionally.
Check
Existing documents against the requirements in your source space: regulations, internal SOPs and the review patterns you bring in. Deviation marked, reference included.
- Binary source check: passed / not passed
- Export as a Word document with evidence
- Your assessment is yours — even if you say no afterwards.
THE TRAQX TRUST ARCHITECTURE
Four controls turn AI output into reviewable work.
01 / 04
What “start free” means in concrete terms
- Full feature set — not a stripped-down trial
- A fixed starting quota for your first documents
- A maximum of 30 days — whichever is reached first ends it
- No payment details
- No automatic renewal
What the quota covers is defined for your case in the intro call.
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.
Can AI update existing Word documents traceably?
Yes. traqx works from the project's sources and rules — including its policies, SOPs and templates. New content starts as a proposal. With an existing Word file, the familiar layout stays intact. Word marks every proposed edit; the adjacent comment shows its source and rationale. The expert reviews directly in traqx; the in-system Word view shows the document and change state.
FAQ
Clear answers before the meeting.
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 happens after sign-up?
You automatically receive all contract documents (including the DPA) by email and book a 15-minute intro call. In it we clarify your document case and activate your access. You then work with the full feature set — until your quota is used up, for a maximum of 30 days.
Why personal activation?
So your first use case lands: in the call we define which document type and which sources go first. That way the test produces a reviewable result instead of a walkthrough.
Does traqx replace our eQMS?
No. traqx does not replace an eQMS, DMS or any other leading system of record, makes no autonomous approval decision and promises no audit outcomes. traqx makes document work reviewable — approval stays with your experts.
What does traqx cost?
Getting started is free: full feature set, a quota for your first documents, a maximum of 30 days, no payment details. Packages then start from €1,000 per month; the scope depends on users and usage. A package only begins after your acceptance and explicit order.
Make your next GxP work state reviewable.
In the 15-minute intro call we clarify your document case and the right free entry. The call is most useful when a specific document, an approval or an audit is coming up for you in the next few weeks.
Start free now →
Registration → 15-minute intro call → personal activation