AI Change Assessment

Blank template

1. Change and authoritative information
2. Approved intended use
3. Affected AI and GxP functions
4. Prompt, source, retrieval, or parser impact
5. Model or version impact
6. Guardrail, workflow, tool, or role impact
7. Acceptance-criteria impact
8. Regression and critical-miss evaluation
9. Human-review impact
10. Rollback, monitoring, and stop criteria
11. Release decision
12. Revalidation criteria and approval

Completed fictional example

Fictional teaching example: This is not an executed or approved validation record.

Change and authoritative information

Fictional provider model quality update and parser 3.2

Approved intended use

Source-linked protocol review comments; no approval authority

Affected AI and GxP functions

Finding generation and scanned-table parsing

Prompt, source, retrieval, or parser impact

Parser changes table extraction; prompt and corpus unchanged

Model or version impact

Provider label is minor but exact behavior may change

Guardrail, workflow, tool, or role impact

No action permissions; source-open requirement retained

Acceptance-criteria impact

Critical-miss criteria by format remain controlling

Regression and critical-miss evaluation

Locked reference set shows two new critical scanned-table misses

Human-review impact

Source inspection falls under representative workload

Rollback, monitoring, and stop criteria

Retain prior path; exclude scanned tables; monitor critical misses and source opens

Release decision

Approve supported text documents only after controls pass

Revalidation criteria and approval

Model, parser, prompt, source, role, threshold, or critical incident; Quality approval