Version 2.0 · Updated 2026-09-21 · Assessment
Assess the AI provider, service boundary, data handling, changes, performance information, security, continuity, and responsibilities.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Before approved AI use and after material supplier, model, data, security, or contract change.
- Approved AI use and data flows
- Provider terms, evidence and subcontractor information
- Version/change controls and customer responsibilities
Field instructions
- Provider and service: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Approved intended use: Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- Customer data handled: Record the agreed responsibilities, permitted data use, locations and third parties. Identify the supporting contract/source and any unresolved dependency.
- Retention and training use: Identify the applicable retention basis, accountable record owner and retrieval method. Confirm obligations and test retrieval before deletion or ending supplier access.
- Sub-processors and locations: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Security and access: Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- Model and service version: Record the exact version/release and effective date from an authoritative source, including configuration identifiers needed to reproduce the assessment.
- Change notification and rollback: Identify the controlled transition or recovery plan, decision owner and evidence of restoration/retrieval. State how incomplete work is detected and reconciled.
- Performance and limitations: State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- Incident and continuity response: Identify the controlled transition or recovery plan, decision owner and evidence of restoration/retrieval. State how incomplete work is detected and reconciled.
- Contractual responsibilities: Record the agreed responsibilities, permitted data use, locations and third parties. Identify the supporting contract/source and any unresolved dependency.
- Conclusion and actions: 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 →