traqx
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Trust · provable for QA, IT and business

Trust is built in the flow of work.

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

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Registration → 15-minute intro call → personal activation

Exported Word review version of a URS with tracked changes, source and rationale comments and a binary source check
Sample review version · synthetic demo data

What QA, IT and business need to see

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

The human defines the task and standard. traqx connects knowledge, documents and agents. The Trust System keeps the basis, change and decision reviewable.

traqx REVIEW OBJECT · CHANGE CONTROL Human review open
Controlled document CC-2026-014 · v0.4

Impact assessment for the proposed system change

The proposal is prepared from the applicable SOP, the current system context and the selected template.

PROPOSED CHANGE

Affected requirements and documents are listed with their source and review state.

↳ SOP-042 · § 7.3 Source check passed
  1. 01
    SourceSOP-042 · approved
    Verified
  2. 02
    Versionv3.4 · valid
    Current
  3. 03
    DecisionAI suggestion · review open
    Human
  4. 04
    TrailWho · what · when · why
    Recorded
✓ Less manual effort✓ Shorter cycle times✓ Traceable decisions

VISIBLE IN THE PRODUCT

Trust is not a promise beside the system.

It is a visible state in the work itself: sources, links, changes and human decisions stay reviewable where the document is created.

Controlled sources in traqx
Real product view · synthetic demo data

01 · Controlled sources

Relevant knowledge stays controlled and connected.

Policies, SOPs, statutory requirements, guidance, best practices, manuals and project files form the defined source space — not the open web.

The expert reviews and decides.

Assurance Ledger

What matters later in an audit is created while you work.

traqx does not turn trust into documentation after the fact. Evidence is created while the work happens: source, version, role, review, decision and boundary stay visible on the work object.

Regulatory references are an assessment frame for the concrete use case. They do not replace a customer-specific validation decision.

Read next: EU GMP Annex 11 vs Annex 22 · EU GMP Annex 22 for AI · ALCOA+ in GxP

Claim Control Boundary
01

“AI supports GxP work.”

Every AI output stays marked as a suggestion until expert review.

02

“Sources are verifiable.”

traqx verifies source references deterministically — independently of human review.

03

“Your data stays your data.”

Customer documents stay within the agreed tenant and hosting scope.

QA

sees not just text, but source verification, review obligation, rationale and decision.

IT

sees data flow, model boundary, hosting setup and deletion logic.

Business

sees speed that is not lost later through rework.

CERTIFICATION STATUS

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

BC/DR · INCIDENT HANDLING

Current status on business continuity, disaster recovery and incident handling: available on request as part of vendor qualification.

PUBLIC BOUNDARY

EU-hosted. No model training on customer data. Validation responsibility and intended use remain customer- and scope-specific.

Quality sign-off · operational review frame

What evidence should Quality require before releasing a GxP AI use?

Before productive use, Quality needs more than a convincing output: a scope-specific evidence package for the system, data, testing and human decision. This frame connects EU GMP Annex 11, the EMA AI reflection paper and the risk-based GAMP lifecycle. The rows are practical go/no-go questions, not a verbatim universal mandatory checklist. Roles and release paths follow the customer-specific PQS and its responsibility matrix.

Sources checked: 18 July 2026 · Evidence depth remains intended-use- and risk-based.
01
Evidence

Intended use & system boundary

Process Owner + QA · approved before use

02
Evidence

Data & source space

Data Owner + QA · permitted space documented

03
Evidence

System & model state

IT / System Owner · release state identified

04
Evidence

Test evidence & acceptance limits

Validation Owner + SME · criteria set in advance

05
Evidence

Human review

Process Owner + QA · role and review depth named

06
Evidence

Audit trail & decision record

System Owner · evidence path checked

07
Evidence

Monitoring & change

System / Model Owner + QA · triggers and escalation defined

08
Evidence

Supplier accountability

Procurement + IT + QA · responsibilities and evidence assessed

DATA AND CONTRACT BASIS

What applies to your data — before you register.

Processing location EU

Hosting and model inference run entirely in the EU. Details on processing are documented in the privacy policy.

Read the privacy policy →

No model training on your data

Your data is not used to train AI models — it remains your data, within the agreed tenant and hosting scope.

DPA and terms available before registration

You can review the contract documents in advance; after registration you receive them automatically by email.

View terms and downloads →

Deletion on request

On request, your data is deleted; we clarify the concrete procedure for the agreed scope.

Built for the AI requirements of EU GMP Annex 22: AI prepares the work, your experts review and decide — traceable in the audit trail.

The draft EU GMP Annex 22 addresses the use of AI in the GMP environment. The controls in traqx — source binding, deterministic source verification, ghost values, human review and the audit trail — keep AI groundwork reviewable along those requirements.

Not a conformity certificate — the customer remains responsible for validating the configured application for its intended use.

INSPECT THE CONTROL LOGIC

Bring one work case. We clarify the required evidence path.

The first appointment is a 15-minute introductory call. If a product walkthrough is the right next step, we arrange the system and strategy call separately.

Start free now →

Registration → 15-minute intro call → personal activation

Continue with: traqxUse casesFAQ