Project control and SOPs
Standard operating procedures (SOPs) and projects in one place: changes justified, reviews closed, one clear version – without mail loops.
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The GxP suite for pharma, biotech & medtech
GxP documentation has
GxP documentation has
never been this easy,
secure and fast.
With traqx you write, review and update the documents that have to hold up in an audit — SOPs, validation and audit documents — in one place. Every sentence with its source, the result as a Word file. Your experts review and approve.
- No blank page: the draft is there – every sentence shows which of your documents it comes from
- Word stays Word – with tracked changes, comments and version history
- We set everything up personally – in about 30 days your team works with it
Non-binding · no payment details · EU-hosted
Evidenced · source and check status visible
Qualifications, memberships and regulations
Born from 17 years of GxP consulting – with consulting projects for Boehringer Ingelheim and Johnson & Johnson, among others. The figures describe the founders' careers, not traqx customer results.
17 yearsof GxP consulting
30,000consulting hours
80 systemsvalidated and supported
10 countriesof project experience
Applications
traqx is built for these tasks:
It always starts with a document you already have – not with our slides.
Computer system validation (CSV) and qualification
When you have to prove that a new system or piece of equipment works reliably: requirements list (URS), risk analysis, test documents and qualification evidence (IQ/OQ/PQ) – evidenced from your approved documents.
Learn moreAudit and inspection readiness
Every statement with its source, every decision in the audit trail – traceable before the auditor asks.
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How traqx works
From the task to the finished Word file – in day-to-day work, not in the next review round.
1
You set the task.
For example: “Align the requirements list (URS) with the outcome of today’s meeting.”
2
traqx researches and proposes.
In your approved SOPs, templates and regulations – every change with its reference and rationale.
3
You review, correct, decide.
The Word file comes back with tracked changes and source comments. Approval stays with your experts.
Watch the product tour
Why traqx
What sets traqx apart from Word, mail and chatbots:
Every statement shows its source.
No sentence without a reference. traqx checks every reference against your approved documents – passed or failed, visible right in the text.
- Source, section and check status on every statement
- Open references stay marked until they are evidenced
- Checked against your SOPs – not against the open web
Your SOPs take precedence.
You decide which documents traqx may consult at all: your SOPs, policies and templates plus regulations such as GAMP 5, Annex 11 or 21 CFR Part 11. We call these approved documents your source room. Your own rules take precedence over the AI's general knowledge; traqx flags conflicts instead of glossing over them.
- One approved source room per project
- Internal requirements before industry guidance
- No model training on your data
Word stays Word.
The .docx comes back with tracked changes, source comments and a continued version history. No new format, no relearning, no migration project.
- Your Word and Excel templates stay in the lead
- Every change with its rationale in a comment
- Handover into your existing approval process
The audit trail is written while you work.
Who changed what, when and why? That is settled before the auditor asks. Traceability is not a project at the end but a by-product of daily work.
- Requirement, test and evidence stay connected
- Every decision with person, role and timestamp
- No proposal becomes effective without human approval
The overview
Everything included – no add-on modules.
An excerpt. You see the full scope in the live demo on your own document.
AgentsDigital helpers that prepare a draft and show for every sentence where it comes from and whether it is evidenced.
Citation checkEvery statement checked against your documents: evidenced or open.
Word reviewThe .docx comes back with tracked changes and comments.
Your approved sourcesOnly your SOPs, policies and regulations – nothing else.
Human approvalNo proposal becomes effective without your approval.
Open proposalsProposals stay visible until you accept or reject them.
Audit trailWho, what, when, why – documented while you work.
Evidence chainRequirement, test and evidence stay connected – no hunting (traceability).
TemplatesYour Word and Excel templates stay in the lead.
Task libraryComputer system validation, SOPs, CAPA, change control, audit – included.
EU hostingGDPR-compliant, no model training on your data.
Does it fit us?We check your case together in the live demo.
Book your personal live demo
Non-binding · personal · straight into the calendar
From practice
Born from 17 years of GxP consulting – not from AI hype.
In regulated work, knowledge is rarely what is missing. Time goes into everything around it: hunting for sources, checking by hand, unclear versions, approvals that wait. traqx was built so that source, version, open points and the human decision are preserved.
17 yearsof GxP consulting in pharma, biotech, CDMO and medtech
80 systemsvalidated and supported
„I was accountable for validations for 17 years – and hit the same friction every time: hunting sources, back-filling evidence, review loops. traqx is the system I needed in every one of those projects.“
Daniel HerrmannCo-founder & CEO · 17 years of GxP consulting
„Compliance software should not feel like a punishment. We build traqx so the safe way is also the easy way: an interface teams actually enjoy using – with an audit trail that writes itself along the way.“
Alexander SchrotCo-founder & CTO · 16+ years of software engineering
Real work case from our own consulting team
Dr. Philipp Cavelius validates customer systems with traqx – evidenced instead of assembled.
ProblemRequirements list (URS), risk analysis and test documents in Word – the sources sit in mail attachments and on the shared drive, evidence is collected at the end.
GoalA work state in which every statement carries its source and check status – review-ready from the first draft.
SolutionWith traqx, evidenced Word review versions with tracked changes are the working result – traceability and the audit trail keep up while the work happens.
„With traqx I start from an evidenced draft instead of an empty document. Source and status stay visible – the professional decision stays with me.“
Dr. Philipp CaveliusCSV specialist in the consulting team traqx emerged from
The difference
Instead of Word + mail + file share: one flow in which the evidence keeps up.
Your documents stay Word. What changes is the way there.
Today
With traqx
Sources and requirements are scattered – in mail attachments, file-share folders and copies.
One approved source room per project; every statement shows its reference.
The draft is done, the evidence is collected afterwards.
Every statement carries source and status: passed or failed.
Review loops by mail: who has which version? What is open?
One work state with visible changes, open points and review status.
Traceability is produced at the end – under time pressure, before the audit.
Traceability and audit trail are written while you work.
Generic AI chatbots: fluent answers without source room, check status and audit trail.
Every statement checked against your approved context – with a visible check status.
New software: set up, fill, understand – on your own.
A set-up workspace, guided until the first productive work case.
What traqx does not do.
You should know what you are buying – and what not.
No eQMS replacement.
Your quality and document systems (QMS, DMS) and every other system of record keep the final say. traqx prepares the document work and hands it into your approval process.
No autonomous approval.
No proposal becomes effective without human review. Assessment, correction and decision stay with your experts.
No promised audit outcomes.
traqx makes work evidenceable but guarantees no inspection result. Validation for your use remains your responsibility.
Your first 30 days
In about 30 days your team works on the first real document:
1
Personal live demo.
You see traqx on a use case from your own practice. Together we check whether traqx fits your situation – before you decide.
2
Workspace setup.
We set up your work area: your approved sources, your templates and the working basis for your first use case. On request we take over the complete setup.
3
Guided go-live.
Onboarding and traqx Academy bring your team into the application. We accompany you to the first productive document – then ongoing support carries on.
Help straight from the founders – not from a ticket system.Onboarding, strategy and technical questions are answered by the people who built traqx.
FAQ
Clear answers before the conversation.
What does traqx cost?
traqx Premium is an annual contract. What it costs depends on exactly two things: which use cases you cover and how many people work with it. We clarify both at the start of the live demo – you receive the concrete offer for your case. The meeting is non-binding, without a traqx account and without payment details.
Does traqx replace our eQMS or DMS?
No. Your QMS, DMS and every leading system of record stay in the lead. traqx prepares the document work – evidenced, traceable, in Word – and hands it into your existing approval process.
How does traqx handle our data?
Your documents are stored on servers in the EU, in an area separated for you, and are not used to train AI models. Sources, proposal status, human review and audit trail stay visible; specific security and validation requirements are clarified for your deployment.
What happens in the live demo?
You see traqx live on a use case from your own practice: controlled source room, evidenced drafts, Word review version. We answer your questions and check together whether traqx fits your situation – on both sides. You book the meeting directly in the calendar, without a traqx account and without payment details.
How long does the introduction take?
In about 30 days your first use case is productive: we set up the workspace, load templates and sources and accompany your team to the first real document.
Is there a free trial?
Yes – after the live demo. If the work case fits, we personally activate your free start: full feature set, a fixed starting quota for your first documents – we tell you how many in the meeting –, a maximum of 30 days, no payment details and no automatic renewal.
See traqx on your own document.
In a personal live demo – on a use case from your practice, non-binding, without payment details and with an honest answer whether traqx fits your situation.
No payment details · no accountEU-hosted · GDPR-compliantThe decision stays with your experts