Version 2.0 · Updated 2026-09-21 · Release
Summarise completed testing, unresolved deviations, residual risks, and the conclusion supporting release.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
Use before documenting the corresponding assessment or decision.
- Approved intended use and functional-risk assessment
- Available supplier and local evidence
- Test environment, representative data and competent reviewers
Field instructions
- Proposed use: Define the precise use proposed for release, including users, functions, environment and excluded actions.
- Evaluated configuration: Identify the exact version and local settings covered by the evidence; explain differences from the proposed release configuration.
- Acceptance basis: Reference approved requirements, risks and predefined acceptance criteria. Identify any changes and their justification.
- Evidence reviewed: List the executed tests, supplier evidence and other reviewed records, including identifiers, versions and material limitations.
- Unresolved issue: Identify each remaining deviation or evidence gap, its impact, owner and proposed restriction or follow-up.
- Impact rationale: Explain why the remaining issue does or does not affect the proposed use, referencing controls and supporting evidence.
- Decision: Record the supported use or restriction, the evidence and unresolved issues behind it, and the accountable decision owner.
- Follow-up: Assign each unresolved finding or additional check to an owner and due date; state the completion evidence required.
- Monitoring: State what will be compared or monitored, against which baseline, by whom and how often. Define discrepancy thresholds and the response.
- Reassessment: Define changes, incidents, performance signals or dates that require review of the release conclusion.
Could the conclusion still be defended if the reviewer only had the linked evidence and this record? An approval signature cannot replace a missing technical basis.
Completed fictional example
Fictional teaching example; replace its values with your own assessed facts and evidence.
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 →