Version 2.0 · Updated 2026-09-21 · Operations
Determine whether an AI model, prompt, source, retrieval, parser, guardrail, workflow, or role change affects approved use or demonstrated performance.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
For planned and supplier-managed AI changes before release.
- Authoritative AI change and version/configuration baseline
- Source, retrieval, model, prompt, parser and workflow dependencies
- Previous evaluation results, acceptance criteria and rollback/monitoring plan
Field instructions
- Change and authoritative information: Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- Approved intended use: Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- Affected AI and GxP functions: Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- Prompt, source, retrieval, or parser impact: Identify the applicable retention basis, accountable record owner and retrieval method. Confirm obligations and test retrieval before deletion or ending supplier access.
- Model or version impact: Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- Guardrail, workflow, tool, or role impact: Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- Acceptance-criteria impact: Define the measures, denominators and risk-based acceptance criteria before execution. Report critical misses separately and explain dataset limitations.
- Regression and critical-miss evaluation: Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- Human-review impact: Define the reviewer’s independent checks, source access, competence and escalation route. Reference evidence that the review detects important errors.
- Rollback, monitoring, and stop criteria: State what will be compared or monitored, against which baseline, by whom and how often. Define discrepancy thresholds and the response.
- Release decision: Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
- Revalidation criteria 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 →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 →