Work case and GxP relevance
Which regulated work is affected, and does every stakeholder understand the same scope?
Decision frame · free PDF
Is your GxP AI pilot ready for a decision? Move from demo to a defensible decision.
Twelve questions help QA, CSV/Validation, IT and business test whether one concrete AI use case stands up technically, functionally and procedurally.
- 12 assessment questions
- for QA · CSV · IT
- no registration
FOUR ANSWERS EVERY TEAM NEEDS FIRST
Work case, sources, human decision, evidence.
- 01Narrow the use case
- 02Set the source scope
- 03Clarify system limits
- 04Define expert review
- 05Measure success and stop signals
Updated 11 July 2026 · traqx GmbH
Direct answer
When is a GxP AI pilot ready for a decision?
A GxP AI pilot is ready for a decision when every role is testing the same use case, the approved source scope is fixed and the team has defined how quality, time, errors and review effort will be measured. The result is a documented decision with clear limits, not a general impression from the demo.
What to assess
Assess the workflow, not just the feature list.
The twelve questions take your decision team from the first task description to a documented decision about use.
Sources and source verification
Which files and versions count, and can every reference be checked against file and section?
Output and expert decision
What may AI prepare, and which assessment explicitly stays with a human?
Data, IT and validation
Where is data held, who has access and when does risk-based controlled operation begin?
Measurement and right to stop
How will benefit and errors be measured, and who may limit or stop use?
Three core questions
Questions many AI demos cannot answer.
The PDF contains twelve assessment questions, each with a good target state and a clear stop signal.
Which sources may AI use?
Documents, versions, owners and excluded drafts need to be fixed before the test.
Stop: the model may draw on arbitrary knowledge.Which review stays with the expert?
Content, sources, changes and open points are reviewed before anything is accepted.
Stop: the same AI reviews and accepts its own output.How will quality, review effort and speed be measured?
A small baseline makes benefit, errors and shifts in review work visible.
Stop: a broad ROI promise replaces measurement.Decision frame
All twelve questions in a print-ready PDF.
For joint preparation by QA, CSV/Validation, IT and business.
How to use the questions
From demo to documented decision.
- 01
Answer them together before the demo
QA, CSV, IT and business align their boundaries before the meeting.
- 02
Verify them on a real use case
Ask to see sources, changes, open points and review status in the system.
- 03
Record the decision with a baseline
Document scope, owners, stop signals, measures and the next review date.
FAQ
Common questions about assessing GxP AI.
Does a first GxP AI test already need validation?
That depends on intended use. A pure evaluation with synthetic data is different from a system whose output already supports regulated work or a GxP record. Control and test depth need to match the actual risk.
Which roles should take part in the assessment?
At minimum, include the process owner, QA, CSV/Validation and IT. Depending on the use case, privacy, information security or further subject-matter experts may be needed. Functional, technical and process boundaries should be assessed together.
Which measures are useful in the first assessment?
Measure time to the first review-ready draft, review effort, detected errors, missing sources and required corrections. A small before-and-after baseline is stronger than a broad efficiency claim.
What should a GxP AI demo actually show?
Not only a good answer. Ask to see the controlled source scope, source verification, document changes, open points, traceability, review status and the path back to a human decision.
Assess the real system
Bring one use case.
We show the traqx System through its sources, document changes and review status. Then we assess how your process and the right module scope fit together.
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