Low-Code Application Assessment

Blank template

1. Platform and supplier
2. Application owner and developer
3. Intended use and prohibited use
4. GxP functions
5. Local rules and workflow
6. Permissions and segregation
7. Interfaces and data
8. Electronic records and signatures
9. Environment and deployment
10. Testing and evidence
11. Change and citizen-developer governance
12. Conclusion and approval

Completed fictional example

Fictional teaching example: This is not an executed or approved validation record.

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