# GxP Assessment Template

Version 1.0 | CSVtoCSA practitioner template | Updated 12 September 2026

## Purpose

Record whether and how a computerized-system use supports a regulated process, required record, calculation, control, or decision.

## When to use

At intake, before choosing a validation category or test package, and whenever intended use changes.

## Instructions

- 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.

## Blank template

1. System and owner

   Response: 

2. Business process

   Response: 

3. Intended use

   Response: 

4. Regulated record or decision

   Response: 

5. Potential GxP impact

   Response: 

6. Applicability conclusion

   Response: 

7. Information needed

   Response: 

8. Approver and date

   Response: 

## Completed fictional example

The example below is teaching material, not an executed or approved validation record.

1. System and owner

   Training Management System; Training Process Owner

2. Business process

   Qualification of manufacturing personnel

3. Intended use

   Calculate whether an operator has completed effective training required for operation OP-21

4. Regulated record or decision

   Training status used to permit controlled work

5. Potential GxP impact

   An expired operator could be treated as qualified

6. Applicability conclusion

   GxP-relevant use; include qualification logic, status interface, access, and record retention

7. Information needed

   Confirm the authoritative curriculum version and interface failure response

8. Approver and date

   Fictional example - to be completed through the organization's approved process

## Use and limitations

Adapt this template to the applicable regulation, approved validation procedure, document-control process, risk method, and approval roles. CSVtoCSA does not present this template as a universally required validation record.