# Intended Use Template

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.

## Information needed before starting

- 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.

| Field | Completed example |
| --- | --- |
| Users | Training coordinators and manufacturing supervisors |
| Process | Manufacturing training qualification |
| Task | Determine operator eligibility for OP-21 |
| Inputs | Identity, role curriculum, completion, and expiry |
| Output | Eligible or not eligible status |
| Decision or record affected | MES permits or prevents operation start |
| Approved environment | Approved production sites and role mappings |
| Exclusions and prohibited uses | Does not establish practical competency or authorize identity provisioning |
| Failure response | Unavailable status prevents start and invokes escalation |
| Reassessment criteria | New role, curriculum-effectivity rule, interface, or override behavior |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Users | ____________________ |
| Process | ____________________ |
| Task | ____________________ |
| Inputs | ____________________ |
| Output | ____________________ |
| Decision or record affected | ____________________ |
| Approved environment | ____________________ |
| Exclusions and prohibited uses | ____________________ |
| Failure response | ____________________ |
| Reassessment criteria | ____________________ |

## Related guidance

- [Write an intended-use statement](https://csvtocsa.com/learn/foundations/intended-use)

- [View the concise intended-use worksheet](https://csvtocsa.com/worksheets/intended-use)

Canonical page: https://csvtocsa.com/templates/intended-use