# Automated Test Evidence Assessment

Version 1.0 | CSVtoCSA practitioner template | Updated 12 September 2026

## Purpose

Determine whether automated testing is suitable, controlled, traceable, and capable of detecting the relevant failure.

## When to use

Before using automated execution records as validation evidence and after material test-tool or application change.

## 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. Validation objective

   Response: 

2. Automated scope and exclusions

   Response: 

3. Test tool intended use and version

   Response: 

4. Test code and review

   Response: 

5. Environment and test data

   Response: 

6. Expected-result independence

   Response: 

7. Failure-detection challenge

   Response: 

8. Execution records and traceability

   Response: 

9. Failure review and rerun rules

   Response: 

10. Maintenance and change impact

   Response: 

11. Coverage limitations

   Response: 

12. Conclusion and approval

   Response: 

## Completed fictional example

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

1. Validation objective

   Detect unauthorized CAPA closure and verify the resulting audit record

2. Automated scope and exclusions

   Stable configured closure path; excludes unusual concurrency exploration

3. Test tool intended use and version

   Execute approved regression and retain machine-readable result

4. Test code and review

   Version controlled and independently reviewed

5. Environment and test data

   Qualified test tenant with representative roles and records

6. Expected-result independence

   Expected rejection derived from approved requirement

7. Failure-detection challenge

   Deliberately enabled unauthorized closure causes test failure after correction

8. Execution records and traceability

   Requirement, risk, test version, input, output, log, result, and reviewer retained

9. Failure review and rerun rules

   Root cause and impact documented before controlled rerun

10. Maintenance and change impact

   Application, test code, library, data, or environment change assessed

11. Coverage limitations

   Does not replace exploratory interruption or role-administration testing

12. Conclusion and approval

   Suitable for defined regression scope after correction

## 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.