Version 2.0 · Updated 2026-09-21 · Assessment
Define the proposed use precisely enough to select risks, controls and evidence.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use when you need to define the proposed use precisely enough to select risks, controls and evidence.
- 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
- System and configuration: Identify the application, version and relevant model/service identifiers.
- Users and process: Name the qualified users and the activity supported.
- Inputs and source documents: Identify source types, permissions, versions and supported formats/languages.
- Outputs and reliance: State the output and how it can influence a decision or record.
- Permitted use: Describe the bounded task and approved conditions of use.
- Exclusions: State prohibited actions and unsupported uses.
- Human review: Specify source verification, independent work, escalation and decision ownership.
- Acceptance basis: Link intended use and failure consequences to the planned evidence.
- Owner and reassessment triggers: Identify accountable roles and changes that require review.
Completed fictional example
Fictional record IU-01 for PRA-01. This is a restricted evaluation use, not an approval for production.
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 →