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.
- 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.
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 →Regulation · United States · Current eCFR text
Scope: Electronic records and signatures within FDA Part 11 scope, tied to the underlying required records.
Relevance: Assess applicability to electronic records required by FDA predicate rules and electronic signatures used in their place. The presence of an electronic record alone is not an applicability conclusion.
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 →