01
traqx standard process
Predefined process logic for CSV, SOP management, audit readiness or qualification. Good when the customer wants to start quickly with a robust standard.
Product · GxP processes with sources, review and release
The traqx system for verifiable GxP work.
traqx connects controlled sources, GxP role agents, template engine, human review and audit trail. You start with one concrete process: either a traqx standard process or your existing process mapped into traqx.
- Use a standard process — proven traqx flows for CSV, SOP, audit readiness and qualification.
- Carry your existing process forward — policies, SOPs, templates, roles and approval paths are scoped and operated in traqx.
- Sources first — every AI output stays tied to source, version, gap and human decision.
- No system replacement required to start — traqx can run standalone or over existing repositories and systems.
EU-hosted · no model training on your data · human release stays mandatory
Sources checkedTemplates controlledReview guidedAudit trail
Product logic
A GxP process becomes a verifiable work object.
traqx is not a chat next to the QMS. It connects sources, process rules, AI draft, review and release in one controlled workflow.
Controlled context
01
GxP foundation
Regulatory and methodological context for the discipline.
02
Your rules
Policies, SOPs, templates, role model, data and document control.
03
Work case
Change, audit question, SOP delta, CSV package or qualification task.
Scope
Process state ready for review
Draft, source map, citation log, gap list, decision and audit trail stay connected.
Policy · SOP · Template
existing context stays visible
Synthetic product case · no customer data
Result
Source
evidenced / open
Process
standard or scoped
Release
human
Made in Germany
GDPR-compliant · EU-hosted
No model training on your data
ArchitectureSOC 2-ready architectureISO 27001-aligned controlsTenant isolation
Control principlesSource bindingDeterministic checkHuman release
Founded by CSV experts with 15+ years of domain expertise
Two start modes
Use a standard process or carry your existing process into traqx.
Customers do not buy an abstract toolkit. They choose a GxP process that is operated under control in traqx.
02
Existing process
Existing policies, SOPs, templates, forms, approval workflows, roles and methods are scoped. The template engine turns them into reusable work objects in traqx.
03
System landscape stays connectable
Document repositories, eQMS, ERP or SharePoint do not have to be replaced on day one. traqx starts with controlled context and clear boundaries.
One system, many use cases, always with sources, review and release.
Migration map
From existing process to controlled traqx work object.
traqx does not blindly ingest documents. The system turns existing process logic into controllable work.
01
Process inventory
Policy, SOP, template, form, data object, role and approval path are captured as leading requirements.
02
Control map
Document control, data control, review steps, approval workflows and methods are separated cleanly.
03
Template engine
Existing templates become reusable fields, rules, review paths and work objects.
04
GxP agents
Agents work only inside the controlled source room and flag gaps instead of inventing process knowledge.
05
Evidence Pack
The operated use case delivers source map, gap list, decision, release and audit-trail excerpt.
Migration becomes process continuity: your existing framework stays leading, traqx makes it verifiable and repeatable.
Check in the product demo
Four questions decide whether traqx holds up in daily work.
The demo should not impress. It should make the process verifiable.
Quality Assurance
Are statements evidenced?
Source, version, open reference and review state stay visible.
Process owner
Does the method fit our process?
Standard process and own scope are evaluated separately.
IT / CSV
Are boundaries clear?
Data and document control, hosting, audit trail and roles are reviewable.
Management
Is the entry small enough?
One prioritised use case is enough for the first decision.
If these questions hold, the demo becomes a clear use-case scope.
Evidence Pack
The demo creates material that can be assessed internally.
The first process delivers a reviewable package, not a slide.
Evidence Pack
One process, five evidence objects
01
Source Map
Which sources and templates were used.
02
Citation Log
Which statement links to which source.
03
Gap List
Which references remain open.
04
Decision Note
Which decision your team made.
05
Audit Trail
Who changed or released what and when.
QA
Reviewability beats demo feeling.
The team checks sources and gaps on the concrete process.IT
System boundaries become visible.
Hosting, data flow, roles and audit trail are traceable.Business
Expansion stays bounded.
One use case first, then further processes. No big bang.This lets a buying center decide whether the first use case should go live.
What the product does
The difference is not AI. It is controlled AI work.
traqx turns scattered sources, templates and decisions into a guided work process.
01 · Source Control
Source room before draft
Outputs are created from approved GxP knowledge, your SOPs, policies, templates and case material.
02 · Process Reuse
Template engine
Recurring documents, data fields, methods and review steps are operated as controlled work objects.
03 · GxP Agents
Role agents
Compliance, Audit, Validation, SOP and Reviewer Agent work with fixed structures and source binding.
04 · Verification
Binary source check
A citation is evidenced or open. Unsupported statements are not polished into claims.
05 · Human-in-the-Loop
Human release
AI stays a suggestion. Release, rejection and rationale stay with the human and in the audit trail.
Agent library
GxP role agents for recurring process work.
The agents are not free chatbots. They work along sources, role logic and review boundaries.
Compliance-Agent
Classifies requirements and evidences statements against controlled sources.
Typical requests
Regulatory questions
Policy comparison
QA decision note
Audit-Agent
Prepares audit answers, evidence paths and gap lists.
Typical requests
Audit questions
Finding patterns
Evidence lists
Boundary Does not guarantee audit readiness.
Validation-Agent
Structures validation work risk-based and source-bound.
Typical requests
URS/FS/DS
Test strategy
Risk assessment
Boundary Does not make the final validation decision.
SOP-Agent
Drafts and updates SOPs along existing templates and policies.
Typical requests
SOP delta
Template comparison
Role logic
Boundary Does not invent references.
Reviewer-Agent
Reviews documents before formal review for gaps and contradictions.
Typical requests
Document review
Critical/Major/Minor
Sign-off prep
Boundary Does not release.
Each agent answers with sources, boundaries and visible open points.
Custom agents
Your working logic for recurring special cases.
If a process is reviewed the same way repeatedly, the method can become a custom agent or template workflow.
Supplier assessment
Review documents against qualification criteria.
Change impact
Connect affected artefacts, risks and tests.
Site rollout
Use the same method across multiple sites.
- Your rules first — internal requirements override generic knowledge.
- Repeatable method — same check, same output, same limits.
- EU-hosted — no model training on your data.
Use cases
Use cases are productized process packages.
A use case is the purchasable, operable process in traqx: scope, sources, templates, agents, review and success criteria.
Cluster A
Computer System Validation
Handle URS, risks, tests, traceability and validation documentation from a controlled source room.
Cluster B
SOP management
Keep SOP deltas, template comparison, role logic and review trail in one guided process.
Cluster C
Audit readiness
Prepare audit questions, evidence, gaps and answer drafts source-bound.
Cluster D
Qualification
Review equipment, process, cleanroom or IT infrastructure along defined methods and templates.
Cluster E
Quality processes
Expand CAPA, Change Control and Supplier Qualification as next process packages.
Use cases are activated with clear scope. Not every process has to run in traqx at once.
Maturity
What is solid today — and what is scoped per use case.
The foundation is live. Process and workflow depth are scoped cleanly per use case.
Solid today
✓ Source room
✓ RAG citations
✓ Role agents
✓ Deterministic source check
✓ Evidence Pack
✓ Audit trail
✓ EU hosting
✓ No model training
Scoped per use case
in development Formal approval workflows
in development E-signature scope
in development Multi-site rollout
in development deep system integration
in development Self-service licensing
traqx does not sell a big bang. The next process is scoped only when the first one is solid.
Positioning
Why traqx is not just an AI chat
The difference sits in sources, process object, review and operation.
| traqx System | AI chat | Office copilot | AI notebook | classic eQMS | |
|---|---|---|---|---|---|
| Source binding | ✓ enforced | ✗ | partial | ✓ | record instead of draft |
| GxP role agents | ✓ | ✗ | ✗ | ✗ | ✗ |
| Template engine | ✓ per scope | ✗ | ✗ | ✗ | partial |
| Audit trail per AI work | ✓ | ✗ | partial IT log | ✗ | ✓ record level |
| Human release | ✓ mandatory | ✗ | ✗ | ✗ | ✓ workflow |
traqx connects AI draft and GxP control in the work object — where review time is created.
The eQMS remains the system of record if the customer operates it that way. traqx makes the AI work before it verifiable.
Validation
Does traqx have to be validated?
What traqx provides
Validation support materials, technical evidence, audit trail, source check and controlled boundaries.
What stays with you
The final assessment and release in your QMS stay with the customer. traqx does not replace that responsibility.
Existing processes
Your as-is process is not a blocker. It is the starting point.
The customer does not have to rebuild the organization around traqx first.
Policy
Which rules apply?
Policies and SOPs are ingested as leading sources.
Template
What should output look like?
Existing templates continue through the template engine.
Workflow
Who reviews and releases?
Review and approval paths are scoped visibly.
Data control
Where is the boundary?
Documents, data and audit history remain controllable.
This is stronger than a module promise: traqx carries the working logic forward without forcing a system replacement.
Commercial entry
Demo on one process, then scope the use case cleanly.
traqx System · commercial entry
Product demo · then core licence and use-case scope
The product demo clarifies the first process. Then core licence (user licence and system operation), process depth and required template/workflow configuration are offered cleanly.
Directional anchor: core licence from approx. €200 per user licence per month; use-case and implementation depth depend on scope.
Request product demo →
Product demo · one process · clear boundaries
Do not start with a broad rollout.
Do not start with a broad rollout.
Start with the right process.
We review whether a traqx standard process fits or whether your existing process should be carried forward through policies, SOPs, templates and review paths.
EU-hosted. No model training on your data. Release stays human.