# Test Strategy Template

Version 1.0 | CSVtoCSA practitioner template | Updated 12 September 2026

## Purpose

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

## When to use

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

## Instructions

- 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.

## Blank template

1. Function

   Response: 

2. Failure scenario

   Response: 

3. Potential impact

   Response: 

4. Existing controls

   Response: 

5. Existing evidence

   Response: 

6. Complexity and uncertainty

   Response: 

7. Selected testing mix

   Response: 

8. Test data and environment

   Response: 

9. Expected records

   Response: 

10. Coverage limitations and approval

   Response: 

## Completed fictional example

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

1. Function

   CAPA approval and closure

2. Failure scenario

   Required Quality approval is bypassed

3. Potential impact

   CAPA closes without required review

4. Existing controls

   Workflow rule and role restriction

5. Existing evidence

   Supplier regression for standard workflow engine

6. Complexity and uncertainty

   Configured branches, legacy blank values, API transition path

7. Selected testing mix

   Targeted scripted branch tests plus exploratory interruption and alternate-path charter

8. Test data and environment

   Representative open records, roles, and legacy site values in the qualified test tenant

9. Expected records

   Executed protocol, charter notes, audit-trail extract, deviations, retest, and conclusion

10. Coverage limitations and approval

   Does not cover disabled modules; Quality approval required

## 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.