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.
- 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.
Blank template
System / record ID: ____________________
Prepared by / date: ____________________
Required review / approval under local procedure: ____________________
Relevant regulations and guidance
These sources apply within their stated scope. The suggested worksheet fields, test designs and fictional decisions are practitioner recommendations, unless a source requirement is expressly identified. Completing a template does not establish compliance.
Regulatory guidance / GMP guideline · United States · February 2026
Scope: Medical-device manufacturers assuring software used in production or their quality management system.
Relevance: For medical-device production or QMS software, supports selecting assurance activities from intended use, risk and available evidence. It is nonbinding guidance and does not determine other sectors’ obligations.
Status: Final / published · Checked 2026-09-21
Publication identity, scope and status checked against the linked official source. This is not an independent audit of every retained guide statement.
Read source details and applicability →Regulatory guidance / GMP guideline · European Union · January 2011 revision
Scope: Computerised systems supporting activities in the applicable EU pharmaceutical GMP context.
Relevance: For computerised systems used in EU GMP activities, informs lifecycle, supplier and record controls. Confirm applicability to the actual activity; the example does not establish it.
Status: Final / published · Checked 2026-09-21
The Commission index confirms the January 2011 operative revision. The linked PDF could not be retrieved in this check; retained detailed section mappings need review against an authorized copy.
Read source details and applicability →