# Low-Code Application Assessment

Version 2.0 · Updated 2026-09-21 · Assessment

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

Adapt this template to your intended use, applicable requirements, and approved procedures.

## When to use it

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

## Information needed before starting

- Application/platform configuration and intended use
- Local workflow rules, permissions and interfaces
- Developer governance, release controls and test evidence

## Field instructions

- **Platform and supplier:** Identify the system/service or process, version and accountable roles. Specify the scope and supporting record rather than relying on a product name alone.
- **Application owner and developer:** 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 and prohibited use:** State what is outside the assessed use or evidence. Explain the consequence and any restriction; do not treat missing information as a pass.
- **GxP functions:** Identify the function or requirement and its controlled reference. Explain the regulated process or record that depends on it.
- **Local rules and workflow:** Identify the approved rule and authoritative source. Include units, identifiers, rounding, missing values and exceptional paths that could change the result.
- **Permissions and segregation:** Identify the account or role, permitted actions and business justification. Check authorization, inappropriate combinations, inactive accounts and evidence of removal or correction.
- **Interfaces and data:** Identify authoritative sources, receiving systems and record identifiers. Describe supported formats, units, timing, transformations and error handling.
- **Electronic records and signatures:** Identify the required record context, history, identity and relationships. Explain how integrity, attribution and retrieval will be preserved and checked.
- **Environment and deployment:** Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- **Testing and evidence:** Identify the assessed configuration, representative data, selected activities and expected results. Include abnormal and recovery paths and explain remaining coverage gaps.
- **Change and citizen-developer governance:** Identify the authoritative change, affected configuration and dependencies. Trace the impact to approved use, controls, evidence and the local change/approval process.
- **Conclusion and approval:** Record the supported decision, restrictions, unresolved issues and rationale. Identify the accountable reviewer/approver and dated evidence under your procedure.

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.

## Completed fictional example

Fictional teaching example; this is not an executed or approved validation record.

| Field | Completed example |
| --- | --- |
| Platform and supplier | Fictional managed low-code platform |
| Application owner and developer | Quality Systems owner; trained configuration developer |
| Intended use and prohibited use | CAPA intake and draft creation; no approval or closure |
| GxP functions | Mandatory intake, routing, source attachment, draft eQMS creation |
| Local rules and workflow | Priority, due date, duplicate check, and owner routing |
| Permissions and segregation | Submitter, triage, administrator, and service account separated |
| Interfaces and data | Acknowledged draft creation in eQMS |
| Electronic records and signatures | eQMS remains authoritative; source link and audit event retained |
| Environment and deployment | Controlled development, test, and production promotion |
| Testing and evidence | Scripted rules and permissions plus exploratory interruption and concurrency |
| Change and citizen-developer governance | Peer review, source control, release approval, periodic inventory |
| Conclusion and approval | Released after server-side rule and service-account correction |

## Blank template

System / record ID: ____________________

Prepared by / date: ____________________

Required review / approval under local procedure: ____________________

| Field | Your entry |
| --- | --- |
| Platform and supplier | ____________________ |
| Application owner and developer | ____________________ |
| Intended use and prohibited use | ____________________ |
| GxP functions | ____________________ |
| Local rules and workflow | ____________________ |
| Permissions and segregation | ____________________ |
| Interfaces and data | ____________________ |
| Electronic records and signatures | ____________________ |
| Environment and deployment | ____________________ |
| Testing and evidence | ____________________ |
| Change and citizen-developer governance | ____________________ |
| Conclusion and approval | ____________________ |

## Related guidance

- [Read the related practical guide](https://csvtocsa.com/learn/guidance/low-code-no-code-validation)

Canonical page: https://csvtocsa.com/templates/low-code-application-assessment