RhizomeOS application boundary
About Validation
V0 foundation
A governed execution environment for proving and maintaining fitness for intended use.
No compliance claim
V0 does not claim electronic signatures, Annex 11 or Part 11 compliance, validated operation, cryptographic immutability, or a compliant audit trail.
Validation owns
- Validation planning and programmes
- Protocols, test execution and evidence references
- Controlled variances and validation risk
- Validation reports and qualification recommendations
- Validated-state decisions, restrictions and periodic review
Explicit boundaries
- Formal deviations, CAPA and change control — Sentinel
- Controlled-document publication — Sentinel
- Raw analytical data and chromatograms — Prism
- Manufacturing, laboratory, warehouse or security execution — domain applications
- Competency records and employee master data — Competency and Personnel
Augustus
Read-only deterministic findings may explain gaps and consequences. They never change regulated state.
Sentinel
Seeded references expose external quality-system decisions. Validation does not duplicate Sentinel workflows.
Local V0 state
Session-persistent browser state supports evaluation of the shell without implying a production backend.