# AI Change Assessment

Version 1.0 | CSVtoCSA practitioner template | Updated 12 September 2026

## Purpose

Determine whether an AI model, prompt, source, retrieval, parser, guardrail, workflow, or role change affects approved use or demonstrated performance.

## When to use

For planned and supplier-managed AI changes before release.

## Instructions

- Define the specific system, service, change, population, and intended use.
- Complete each field from available records and accountable interviews; record unknowns rather than guessing.
- Link conclusions to affected GxP functions, failure scenarios, controls, evidence, and approval.
- Adapt the structure to the organization’s approved procedures and document-control process.

## Blank template

1. Change and authoritative information

   Response: 

2. Approved intended use

   Response: 

3. Affected AI and GxP functions

   Response: 

4. Prompt, source, retrieval, or parser impact

   Response: 

5. Model or version impact

   Response: 

6. Guardrail, workflow, tool, or role impact

   Response: 

7. Acceptance-criteria impact

   Response: 

8. Regression and critical-miss evaluation

   Response: 

9. Human-review impact

   Response: 

10. Rollback, monitoring, and stop criteria

   Response: 

11. Release decision

   Response: 

12. Revalidation criteria and approval

   Response: 

## Completed fictional example

The example below is teaching material, not an executed or approved validation record.

1. Change and authoritative information

   Fictional provider model quality update and parser 3.2

2. Approved intended use

   Source-linked protocol review comments; no approval authority

3. Affected AI and GxP functions

   Finding generation and scanned-table parsing

4. Prompt, source, retrieval, or parser impact

   Parser changes table extraction; prompt and corpus unchanged

5. Model or version impact

   Provider label is minor but exact behavior may change

6. Guardrail, workflow, tool, or role impact

   No action permissions; source-open requirement retained

7. Acceptance-criteria impact

   Critical-miss criteria by format remain controlling

8. Regression and critical-miss evaluation

   Locked reference set shows two new critical scanned-table misses

9. Human-review impact

   Source inspection falls under representative workload

10. Rollback, monitoring, and stop criteria

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

11. Release decision

   Approve supported text documents only after controls pass

12. Revalidation criteria and approval

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

## Use and limitations

Adapt this template to the applicable regulation, approved validation procedure, document-control process, risk method, and approval roles. CSVtoCSA does not present this template as a universally required validation record.