From document structure to audit trails, every capability is built to keep your trial master file complete and compliant.
Every document maps to the DIA TMF Reference Model. Zones, sections, and artifacts are predefined. Add custom artifacts when your study requires it.
See how complete your TMF is at any point in the trial. Identify missing or overdue documents before they become findings. Filter by zone, site, or study phase.
Full version history on every document. Role-based permissions at study, site, and zone level. Lock finalized versions while keeping drafts editable.
Every upload, view, approval, and change is recorded automatically. Immutable, timestamped logs filterable for inspectors and quality teams.