Version 2.0 · Updated 2026-09-21 · Assessment
Define what users rely on the system to do, the data and outputs involved, the operating boundary, and prohibited uses.
Adapt this template to your intended use, applicable requirements, and approved procedures.
When to use it
During validation planning, requirements development, change assessment, and AI-use approval.
- Process owner’s task description
- User roles, inputs, outputs and receiving decisions
- Assessed configuration and excluded uses
Field instructions
- Users: Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- 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.
- Task: Describe the specific task, users, outputs and decisions supported. Identify the assessed environment and limits of reliance.
- Inputs: Identify authoritative sources, receiving systems and record identifiers. Describe supported formats, units, timing, transformations and error handling.
- Output: Name the output or controlled record, its recipient and the decision that relies on it. Include acceptance limits or retention needs where relevant.
- Decision or record affected: Name the output or controlled record, its recipient and the decision that relies on it. Include acceptance limits or retention needs where relevant.
- Approved environment: Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- Exclusions and prohibited uses: State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- Failure response: State the safe or controlled behavior when inputs, services or results are unavailable or incorrect. Define containment, escalation and recovery responsibilities.
- Reassessment criteria: Define changes or events that reopen this assessment, the responsible role and the required response or review date.
Describe one meaningful regulated use.
Name users, process, inputs, output, and decision authority.
State the approved environment and relevant exclusions.
Make the statement specific enough to drive risk assessment and testing.
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 →