Version 2.0 · Updated 2026-09-21 · Assessment
Record whether and how a computerized-system use supports a regulated process, required record, calculation, control, or decision.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
At intake, before choosing a validation category or test package, and whenever intended use changes.
- Proposed process, users and outputs
- Applicable quality process and record requirements
- System and process owners who can resolve uncertainties
Field instructions
- System and owner: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Business process: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- Intended use: Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- Regulated record or decision: Name the output or controlled record, its recipient and the decision that relies on it. Include acceptance limits or retention needs where relevant.
- Potential GxP impact: Describe a credible incorrect, missing or delayed result and trace it to the affected process, record or decision. Distinguish severity from how often it could occur.
- Applicability conclusion: Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
- Information needed: List the unanswered questions or missing evidence, the action owner and due date. Explain what cannot be concluded until they are resolved.
- Approver and date: Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.
Assess the proposed use, not the product name.
Identify the applicable regulated process and record.
Trace a realistic software failure to its potential GxP consequence.
Record uncertainties and the accountable approval route.
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 →