What you are proving
Validation shows whether an asset version was challenged against requirements with evidence and approvals. Formal deliverable documents use QualityDocs.
Object layers
| Object | Purpose |
|---|---|
| Validation entity family | Group equivalent assets; shared mandatory requirements |
| Validation entity | Asset under validation (e.g. a MES line) |
| Validation entity version | Point-in-time version — requirements and activities attach here |
| Validation requirement | URS/FRS/spec item |
| Validation activity | Project with scope, dates, participants, deliverables |
| Validation deliverable | Placeholder in an activity; body in document or test record |
Attach requirements to entity versions, not a vague asset label.
Team vs script roles
| Layer | Purpose |
|---|---|
| Validation Team on entity | Visibility to requirements, scripts, deliverables |
| Script lifecycle roles | Author, execute, independent review, approve via tasks |
Team membership does not assign execution tasks.
Activity lifecycle (summary)
- Create activity on entity version.
- Maintain deliverable list.
- Send for approval — workflow tasks (test execution).
- Complete activity only when deliverables and script conclusions satisfy checks.
Cross-links
QMS change control may require new activities or regression OQ. Requirements may reference change numbers and controlled SOPs.
FAQ
| Symptom | What to check |
|---|---|
| Requirement on wrong level | Move to entity version |
| Cannot see scripts | Team assignment / DAC |
| Cannot complete activity | Deliverable and script rollup checks |