Version 2.0 · Updated 2026-09-21 · Operations
Determine whether current operational evidence continues to support the approved intended use and validated state.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
At the approved review frequency and after significant accumulated change, incident trends, or supplier changes.
- Review period and current approved system baseline
- Change, incident, access and service records
- Backup/recovery evidence and previous review actions
Field instructions
- System, scope, and review period: Identify the system/configuration, included uses and start/end dates of the review. Explain any excluded function or evidence period.
- Current intended use and configuration: Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- Changes and releases: Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- Incidents, deviations, and CAPA: Record the issue, affected functions/records, impact, containment, action owner and resolution or expiry. Link correction and retest evidence; retain unfavorable results.
- Access and audit-trail review: Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- Backup, restore, and continuity: Identify the controlled transition or recovery plan, decision owner and evidence of restoration/retrieval. State how incomplete work is detected and reconciled.
- Supplier and service performance: Summarise relevant service metrics, incidents, support, change notices and contract performance during the review period, including trends and actions.
- Open actions and evidence gaps: List the unanswered questions or missing evidence, the action owner and due date. Explain what cannot be concluded until they are resolved.
- Validated-state conclusion: Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
- Next review or event trigger: Define changes or events that reopen this assessment, the responsible role and the required response or review date.
Confirm the current intended use, owner, version, and configuration.
Review changes, deviations, incidents, access, audit trails, backup/restore, supplier status, and performance.
Identify stale evidence or changed assumptions.
Record actions, residual risk, and the validated-state conclusion.
Completed fictional example
Fictional teaching example; this is not an executed or approved validation record.
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 →