# Low-Code Application Assessment

Version 1.0 | CSVtoCSA practitioner template | Updated 12 September 2026

## Purpose

Separate platform assurance from locally configured GxP rules, workflows, permissions, interfaces, records, and releases.

## When to use

For citizen-developed or centrally configured low-code and no-code applications.

## Instructions

- Define the specific system, service, change, population, and intended use.
- Complete each field from available records and accountable interviews; record unknowns rather than guessing.
- Link conclusions to affected GxP functions, failure scenarios, controls, evidence, and approval.
- Adapt the structure to the organization’s approved procedures and document-control process.

## Blank template

1. Platform and supplier

   Response: 

2. Application owner and developer

   Response: 

3. Intended use and prohibited use

   Response: 

4. GxP functions

   Response: 

5. Local rules and workflow

   Response: 

6. Permissions and segregation

   Response: 

7. Interfaces and data

   Response: 

8. Electronic records and signatures

   Response: 

9. Environment and deployment

   Response: 

10. Testing and evidence

   Response: 

11. Change and citizen-developer governance

   Response: 

12. Conclusion and approval

   Response: 

## Completed fictional example

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

1. Platform and supplier

   Fictional managed low-code platform

2. Application owner and developer

   Quality Systems owner; trained configuration developer

3. Intended use and prohibited use

   CAPA intake and draft creation; no approval or closure

4. GxP functions

   Mandatory intake, routing, source attachment, draft eQMS creation

5. Local rules and workflow

   Priority, due date, duplicate check, and owner routing

6. Permissions and segregation

   Submitter, triage, administrator, and service account separated

7. Interfaces and data

   Acknowledged draft creation in eQMS

8. Electronic records and signatures

   eQMS remains authoritative; source link and audit event retained

9. Environment and deployment

   Controlled development, test, and production promotion

10. Testing and evidence

   Scripted rules and permissions plus exploratory interruption and concurrency

11. Change and citizen-developer governance

   Peer review, source control, release approval, periodic inventory

12. Conclusion and approval

   Released after server-side rule and service-account correction

## 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.