# Automated Test Evidence Assessment

Version 2.0 · Updated 2026-09-21 · Testing

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

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

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

## Information needed before starting

- Defined claims and risks the tests address
- Versioned test code, test data and expected results
- Evidence of review, execution and failure-detection challenges

## Field instructions

- **Validation objective:** Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- **Automated scope and exclusions:** State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- **Test tool intended use and version:** Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- **Test code and review:** Identify the test method/tool version and review evidence. Challenge known failures to show the method can detect the errors it is relied on to find.
- **Environment and test data:** Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- **Expected-result independence:** Identify an independently reviewed specification or calculation for expected results; do not reuse the same unverified algorithm being tested.
- **Failure-detection challenge:** Introduce a known incorrect result or condition and demonstrate that the test method detects it. Preserve the challenge and observed failure record.
- **Execution records and traceability:** Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- **Failure review and rerun rules:** Describe a credible incorrect, missing or delayed result and trace it to the affected process, record or decision. Distinguish severity from how often it could occur.
- **Maintenance and change impact:** Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- **Coverage limitations:** State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- **Conclusion and approval:** Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.

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

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Validation objective | ____________________ |
| Automated scope and exclusions | ____________________ |
| Test tool intended use and version | ____________________ |
| Test code and review | ____________________ |
| Environment and test data | ____________________ |
| Expected-result independence | ____________________ |
| Failure-detection challenge | ____________________ |
| Execution records and traceability | ____________________ |
| Failure review and rerun rules | ____________________ |
| Maintenance and change impact | ____________________ |
| Coverage limitations | ____________________ |
| Conclusion and approval | ____________________ |

## Related guidance

- [Read the related practical guide](https://csvtocsa.com/learn/guidance/automated-testing-evidence)

Canonical page: https://csvtocsa.com/templates/automated-test-evidence-assessment