Platform and applications
The platform is the base every vault uses. Clinical Operations and Quality are application families on that base. Applications in one family can live in the same vault and share the same objects, documents, and security model.
Application help describes only what that application adds. How a deviation is opened is in QMS. How a document moves from draft to effective is in QualityDocs. How a trial master file is completed is in eTMF. The capabilities below are not repeated in each application; use the learning path before diving into product lines.
Shared capabilities (expanded)
Objects and records
Business data is records on objects. Fields, object types, page layouts, and related lists decide what a record looks like and which related rows are visible. List pages use columns and filters; detail pages change visible and read-only fields by lifecycle state.
Documents
Documents have types, a version family, and a lifecycle. The latest version is the only editable entry point; historical versions are frozen read-only. QualityDocs and eTMF both sit on this capability, then add state names, review roles, and filing rules.
Lifecycles and workflows
A lifecycle is the step a record or document is in. Simple moves use user actions on the record. When participants, comments, or e-signatures are required, use a workflow: send for approval, then complete tasks in My Tasks—not approve/reject from the state menu alone.
Security and audit
Who can see, create, or edit is decided by Security Profile, PermissionSet, record sharing, and lifecycle roles together. Important changes write object audit rows; signatures on workflow tasks create read-only signature child records. When an application creates a child record on behalf of someone, audit still shows the click user as On Behalf Of.
Learning path (business users)
| You mainly… | Suggested order |
|---|---|
| Create records, edit fields, related lists | Objects, lists, and detail → Security basics |
| Send for approval, confused with state menu | Lifecycles and user actions → My tasks |
| Upload files, major/minor versions | Documents and versions → Clinical or QualityDocs |
| Sign-off, who changed what | E-signature and audit |
| Quality deviations / change control | Quality help |
| Trial eTMF | Clinical Operations |
Day-to-day index
| Goal | Article |
|---|---|
| Tabs, lists, create, saved views | Objects, lists, and detail |
| State menu vs workflow | Lifecycles and user actions |
| Approve tasks, due dates, filters | My tasks |
| Missing tab or forbidden | Security basics |
| Minor/major version, frozen history | Documents and versions |
| Task e-sign, audit trail | E-signature and audit |
Relation to Vivarcus specs
This help is for logged-in business users, not MDL load or Admin click paths. Behavior aligns with in-repo product semantics; when your vault differs from a Veeva sandbox label, trust your vault configuration and audit.
Application families
- Trial documents and study operations: Clinical Operations
- Controlled documents and quality processes: Quality