# Test Strategy Template

Version 2.0 · Updated 2026-09-21 · Testing

Select a proportionate mix of scripted, unscripted, exploratory, automated, supplier, qualification, and user testing.

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

## When to use it

After the functional risk assessment and evidence review, before protocol or charter approval.

## Information needed before starting

- Approved intended use and functional-risk assessment
- Available supplier and local evidence
- Test environment, representative data and competent reviewers

## Field instructions

- **Function:** Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- **Failure scenario:** 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.
- **Potential impact:** 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.
- **Existing controls:** Describe the preventive or detective control, its owner and evidence that it works in the assessed configuration.
- **Existing evidence:** Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- **Complexity and uncertainty:** Explain the remaining uncertainty and consequences after controls. State how an error would be detected before it affects the regulated decision.
- **Selected testing mix:** Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- **Test data and environment:** Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- **Expected records:** Reference the exact evidence, version, date and assessed conditions. Explain the claim it supports, how it was reviewed and what remains unproven locally.
- **Coverage limitations and approval:** Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.

Start from the failure scenario and potential impact.

Record existing controls and applicable evidence.

Choose the method that can expose the failure.

Define expected records, deviation handling, and coverage limitations.

## Completed fictional example

Fictional teaching example; this is not an executed or approved validation record.

| Field | Completed example |
| --- | --- |
| Function | CAPA approval and closure |
| Failure scenario | Required Quality approval is bypassed |
| Potential impact | CAPA closes without required review |
| Existing controls | Workflow rule and role restriction |
| Existing evidence | Supplier regression for standard workflow engine |
| Complexity and uncertainty | Configured branches, legacy blank values, API transition path |
| Selected testing mix | Targeted scripted branch tests plus exploratory interruption and alternate-path charter |
| Test data and environment | Representative open records, roles, and legacy site values in the qualified test tenant |
| Expected records | Executed protocol, charter notes, audit-trail extract, deviations, retest, and conclusion |
| Coverage limitations and approval | Does not cover disabled modules; Quality approval required |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Function | ____________________ |
| Failure scenario | ____________________ |
| Potential impact | ____________________ |
| Existing controls | ____________________ |
| Existing evidence | ____________________ |
| Complexity and uncertainty | ____________________ |
| Selected testing mix | ____________________ |
| Test data and environment | ____________________ |
| Expected records | ____________________ |
| Coverage limitations and approval | ____________________ |

## Related guidance

- [Choose a testing approach](https://csvtocsa.com/learn/foundations/testing)

- [Open the exploratory test charter](https://csvtocsa.com/worksheets/test-charter)

Canonical page: https://csvtocsa.com/templates/test-strategy