Version 2.0 · Updated 2026-09-21 · Operations
Connect signals and changes to impact, containment, evidence and continued-use decisions.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use when you need to connect signals and changes to impact, containment, evidence and continued-use decisions.
- 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
- Use and baseline: Record current intended use, configuration and evidence basis.
- Signal or change: Describe observed error, model/source/interface change or changed user reliance.
- Affected requirements and risks: Identify what claims or controls might no longer be supported.
- Impact and containment: Identify affected outputs/decisions and any temporary restrictions.
- Evidence and retest: Specify targeted regression, source, permission and reviewer evaluation needed.
- Monitoring owner and frequency: Name responsible roles and a risk-appropriate review schedule.
- Incident / deviation / CAPA: Link the applicable procedure and actual investigation/action records.
- Periodic review and conclusion: Reconcile trends, changes and open issues; state continued-use disposition.
- Approval and reassessment trigger: Identify local approval responsibilities and future triggers.
Completed fictional example
Fictional restricted pilot controls. Frequencies are teaching choices, not universal requirements.
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 →