traqxGxP Compliance Software
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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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Two quality professionals concluding a document review together

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 Architecture 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

AI preparesresearch · drafts · updates · candidate traces
Experts verifycorrectness · correction · acceptance · decision
traqx makes visiblesource · status · change · review path · audit trail
Customer data stays protectedagreed tenant and hosting scope · no model training on customer data

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.

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