Version 2.0 · Updated 2026-09-21 · Testing
Record issue-level results and retain a traceable basis for metrics and the decision.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use when you need to record issue-level results and retain a traceable basis for metrics and the decision.
- Defined AI use, authority limits and assessed configuration
- Controlled sources and independent reference results relevant to this worksheet
- Applicable risk assessment, acceptance basis and responsible reviewers
Field instructions
- Requirement or risk reference: Link the requirement and failure being evaluated.
- Test category: State normal, negative, boundary, source, repeatability or other defined category.
- Reference result: Record the independently established expected finding and its source.
- AI result: Record the actual finding or omission and execution/configuration identifiers.
- Severity: Use the predefined local rubric and keep critical results separate.
- Outcome: Record correct, false, missed or unresolved, with adjudication rationale.
- Deviation reference: Link failed criteria and required actions; do not hide failures from totals.
- Conclusion: Explain permitted reliance, exclusions and unresolved uncertainty.
- Units and design: Record distinct documents, reference issues and repeated runs separately; identify dependencies.
Completed fictional example
Synthetic T-01 includes 12 documents and 40 reference issues: 10 critical and 30 major. The AI reports 38 findings: 32 correct and six false. Eight issues are missed, including two critical. Precision 84.2%; recall 80%; critical recall 80%. The rows below are illustrative extracts, not the entire 40-issue register.
Blank template
System / record ID: ____________________
Prepared by / date: ____________________
Required review / approval under local procedure: ____________________
Blank results or assessment rows
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 →Industry guidance / framework · United States · AI RMF 1.0 (2023); GenAI Profile (2024)
Scope: Cross-sector AI governance and risk management, including generative AI.
Relevance: A voluntary framework for describing AI risks, evaluation and ongoing management. Its suggested practices are not regulatory requirements.
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 →