Version 2.0 · Updated 2026-09-21 · Release
Reconcile the evidence, failures and operating restrictions into an assessable release decision.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use when you need to reconcile the evidence, failures and operating restrictions into an assessable release 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
- Use and configuration: Identify the exact proposed use, users and evaluated configuration.
- Applicable scope: Link the local GxP, record and jurisdiction assessment.
- Evidence reviewed: List requirements, risks, supplier evidence, tests and reviewer evaluation.
- Acceptance results: Report successes and failures by their stated criteria.
- Traceability: Link each relevant requirement/risk to evidence and deviation disposition.
- Open issues: State the impact of each unresolved deviation or dependency.
- Conclusion and restrictions: Describe what is permitted, withheld or excluded, and why.
- Operational readiness: Identify record, monitoring, incident, change and periodic-review arrangements.
- Approval responsibility: Identify required local approval roles; do not invent a signature.
- Reconsideration triggers: State the additional evidence needed before changing the decision.
Completed fictional example
Fictional VSR-01 records a withheld expansion, not a successful production validation.
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 →