When to read this
You upload content, replace PDFs, interpret 0.1 vs 1.0, or find old versions read-only. Platform rules here; trial review in eTMF, controlled docs in QualityDocs.
Document family
A library document is a family:
| Concept | Meaning |
|---|---|
| Latest version | Only editable entry: file, state, attributes |
| Version rows | One row per bump; prior latest freezes read-only |
| Placeholder | Shell first; first file still on current latest (e.g. 0.1) |
Work on latest; history for comparison and audit.
Create and first file
- Create document, pick type/subtype.
- First upload → usually 0.1, not 1.0.
- Placeholder allowed before first binary.
See Security basics if Create is missing.
Metadata sync vs bump
| You do | Version | Notes |
|---|---|---|
| Metadata only | Unchanged | Syncs to current version row |
| Check in / new version | Minor +1 | Old latest frozen |
| Steady state (approved/effective) | Major +1, minor reset | e.g. 0.3 → 1.0 |
| Change PDF while effective | New draft/bump | Cannot overwrite 1.0 file in place |
Replace file = bump, never same version number overlay.
Examples
| Path | Meaning |
|---|---|
| 0.1 → 0.2 → 0.3 | Draft iterations |
| 0.3 → 1.0 | Promotion at steady state |
| 1.0 → 1.1 | Post-effective minor change (if allowed) |
| Parallel 0.1 | Often create draft from effective |
Exact numbering is vault-defined.
State and lifecycle
state__v on latest version via user actions or workflow.
| Line | Read |
|---|---|
| Trial TMF | eTMF review |
| Quality controlled | QualityDocs overview |
| After review | Document review, Change control |
Approval completes in My Tasks like records.
View, preview, download
| Action | Constraints |
|---|---|
| Preview | Viewable rendition per type |
| Download | download + state |
| Open history | Read-only snapshot |
| Audit | View/download/check-out; E-signature and audit |
Check-out (if enabled)
Checkout may block concurrent bumps—check in or cancel per procedure.
Links to business records
Relationships to deviations, change controls, studies, etc. Removing a link does not delete the family.
FAQ
| Symptom | Try |
|---|---|
| No 1.0 yet | Not promoted; check history list |
| Cannot edit old PDF | Frozen; bump latest or create draft |
| Title change, same version | Expected until file bump |
| Confusing state name | Application help; platform keeps state on latest |
Next
- Workflow → Lifecycles and user actions, My tasks
- Signatures → E-signature and audit