# GxP Assessment Template

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.

## Information needed before starting

- 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.

| Field | Completed example |
| --- | --- |
| System and owner | Training Management System; Training Process Owner |
| Business process | Qualification of manufacturing personnel |
| Intended use | Calculate whether an operator has completed effective training required for operation OP-21 |
| Regulated record or decision | Training status used to permit controlled work |
| Potential GxP impact | An expired operator could be treated as qualified |
| Applicability conclusion | GxP-relevant use; include qualification logic, status interface, access, and record retention |
| Information needed | Confirm the authoritative curriculum version and interface failure response |
| Approver and date | Fictional example - to be completed through the organization's approved process |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| System and owner | ____________________ |
| Business process | ____________________ |
| Intended use | ____________________ |
| Regulated record or decision | ____________________ |
| Potential GxP impact | ____________________ |
| Applicability conclusion | ____________________ |
| Information needed | ____________________ |
| Approver and date | ____________________ |

## Related guidance

- [Assess the system’s GxP use](https://csvtocsa.com/learn/gxp-assessment)

- [Review the training-system example](https://csvtocsa.com/case-studies/training-management-qualification-status)

- [Open System Assessment](https://csvtocsa.com/tools/system-use)

Canonical page: https://csvtocsa.com/templates/gxp-assessment