# AI Use Assessment Template

Version 1.0 | CSVtoCSA practitioner template | Updated 12 September 2026

## Purpose

Define and evaluate an AI-enabled GxP use, its decision authority, failure scenarios, human review, evidence, monitoring, and revalidation criteria.

## When to use

Before pilot or production use of machine learning, generative AI, retrieval-augmented generation, or agentic functions in a regulated process.

## Instructions

- Define the AI task and prohibited actions at feature level.
- Identify decision authority and realistic failures, including critical misses.
- Specify reference data, metrics, acceptance criteria, and human-review effectiveness.
- Control model, prompt, retrieval, data, tools, access, monitoring, and change.

## Blank template

1. Intended use and AI function

   Response: 

2. Decision authority and prohibited uses

   Response: 

3. Data, population, and reference dataset

   Response: 

4. Failure scenarios and critical misses

   Response: 

5. Human review design

   Response: 

6. Performance measures and acceptance criteria

   Response: 

7. Source verification and data integrity

   Response: 

8. Access, audit trail, and supplier responsibilities

   Response: 

9. Testing and release conditions

   Response: 

10. Monitoring, stop, and revalidation criteria

   Response: 

## Completed fictional example

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

1. Intended use and AI function

   Draft nonauthoritative validation-protocol review comments from permitted documents

2. Decision authority and prohibited uses

   Qualified reviewer disposes findings; AI cannot approve, reject, sign, or release a document

3. Data, population, and reference dataset

   Approved English-language protocol types with independently established reference findings

4. Failure scenarios and critical misses

   Missed approval, false traceability gap, wrong source version, unsupported compliance claim

5. Human review design

   Reviewer sees source passage, requirement, and rationale and can accept, reject, or request clarification

6. Performance measures and acceptance criteria

   Critical-finding recall, false findings, citation correctness, performance by issue type, and reviewer detection

7. Source verification and data integrity

   Immutable source version and page/section reference retained with the potential finding

8. Access, audit trail, and supplier responsibilities

   Role-restricted use; input, version, output, disposition, and change recorded

9. Testing and release conditions

   Representative challenge set and human-workflow study; scanned handwritten records excluded

10. Monitoring, stop, and revalidation criteria

   Stop on critical-miss threshold, source failure, unauthorized action, or material model/prompt/parser change

## 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.