How to Separate an AI Draft From an Approved Laboratory Record

Name the stages used locally, such as generated draft, under review, returned for correction and approved record. Define what each state permits.

Do not rely on colour alone or informal wording that staff may interpret differently.

Display the draft status, source workflow, generation time and relevant version wherever the content is viewed or exported.

A polished format must not make unreviewed content appear authorised.

Prevent drafts from entering reporting, release or decision workflows until the required controls are complete. Use technical and procedural controls appropriate to the system.

Qualified human oversight remains essential wherever professional, regulatory or safety judgement is required.

Keep the relevant inputs, model or workflow version, reference sources and changes available under suitable access controls.

Minimise sensitive data and follow applicable retention, privacy and information-governance requirements.

Record the authorised reviewer, date, scope, rationale and final version. Approval should apply to an identifiable record, not an evolving draft.

Do not treat silence, elapsed time or an automated status change as professional approval.

Retain the approved version and create a controlled amendment or replacement according to local procedure. Link the reason and responsible reviewer.

Test the separation through approved scenarios and include it in change control, training and periodic review.

Can an AI draft be used because it looks complete? No. Can the same person always generate and approve it? Follow the organisation's segregation and competence rules. Is this clinical advice? No.