Version 2.0 · Updated 2026-09-21 · Assessment
Record actual use, influence and the requirements that need a local applicability decision.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use when you need to record actual use, influence and the requirements that need a local applicability 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
- Intended use: Describe the specific task, permitted reliance and exclusions.
- Users: Identify roles, qualifications and responsibility for decisions.
- Process supported: Identify the regulated or nonregulated process and jurisdiction.
- Inputs and sources: Identify source documents, revisions and authority.
- Outputs: Describe drafts, findings, records and actions.
- Influence on work or decisions: Trace how output or omission can change work or a decision.
- Human review: Describe the full verification and independent review required.
- Failure consequences: Describe incorrect and missing outputs and possible process effects.
- Requirements requiring assessment: Identify relevant sector, record and local requirements without assuming universal applicability.
- Scope conclusion and rationale: State included functions, limits, assumptions and unresolved questions.
- Responsible roles and evidence: Record the actual local assessment and approval process; never copy fictional approval.
Completed fictional example
Fictional GXP-01 assumes a US-market medical-device manufacturer and protocol review in a production-equipment validation process.
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 →