Version 2.0 · Updated 2026-09-21 · Testing
Test whether the complete review workflow delivers the risk reduction being claimed.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use when you need to test whether the complete review workflow delivers the risk reduction being claimed.
- 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
- Task and proposed reliance: Define what reviewers must decide and what AI output may influence.
- Reviewer prerequisites: Record process knowledge, source access, AI limitations, time, authority and procedural training.
- Cases and expected results: Identify representative cases, independently adjudicated reference results and scoring rubric.
- Design and independence: Record users, conditions, assignments, order and measures against answer leakage.
- Acceptance criteria: Set outcome and critical-failure rules before testing; justify them for the intended use.
- Observed outcome: Score final correct/false/missed findings, source verification and escalation.
- Limits and deviations: Retain dependency/coverage limits, failures and open corrective actions.
- Decision and retest: State reliance restrictions and the fresh evidence needed after changes.
Completed fictional example
Synthetic HR-01 uses six reviewers, each completing two assisted and two unassisted sessions. Twelve documents appear once per condition with different reviewers: 24 sessions total. Each condition covers 40 reference issues including ten critical.
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 →