Version 2.0 · Updated 2026-09-21 · Planning
Link each important GxP function to a failure scenario, process effect, potential consequence, controls, and required evidence.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
After intended use and requirements are sufficiently understood and before finalizing test depth.
- Defined intended use and important requirements
- Credible failure scenarios and consequences
- Existing controls and available evidence
Field instructions
- GxP function or requirement: Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- Failure scenario: 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.
- Process effect: 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.
- Potential 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.
- Existing controls: Describe the preventive or detective control, its owner and evidence that it works in the assessed configuration.
- Detectability: Explain the remaining uncertainty and consequences after controls. State how an error would be detected before it affects the regulated decision.
- Risk rationale: Explain the remaining uncertainty and consequences after controls. State how an error would be detected before it affects the regulated decision.
- Mitigation or evidence needed: List the unanswered questions or missing evidence, the action owner and due date. Explain what cannot be concluded until they are resolved.
- Residual risk: Explain the remaining uncertainty and consequences after controls. State how an error would be detected before it affects the regulated decision.
- 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.
Assess functions separately rather than assigning one risk to the whole system.
Describe observable failure and process effect.
Credit only controls that address the failure and can be shown to work.
Use the remaining risk and uncertainty to select evidence.
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 →