H1ST-AI-DOC-006 · Task 6.1
Your TMF shouldn't scare you before an inspection
Walking into an inspection already ready, because the file has been ready all along, is the difference this makes. The agent orchestrates document movement through configurable BPMN workflows aligned to the TMF Reference Model v3.3.1 (250 artifacts across 11 zones), enforcing review, approval, and QC steps with SLA timers, and capturing every routing decision, hand-off, and status change to an ALCOA+ audit trail. Sponsors and CROs get a single, visual system of record for document flow instead of email chains and shared drives.
The grind you know
When your TMF documents move through ad hoc email approvals and manual filing, you are left without a reliable record of who did what, or when. The missing or late artifacts you dread surface only at inspection, the one moment you can no longer reconstruct the workflow. You cannot see SLA status in real time, so you cannot prove timeliness or completeness against the Reference Model until someone asks and it is too late.
Part of the eTMF & Documents family
An eTMF that files and manages itself.
Walking into an inspection already ready, because the file has been ready all along, is the difference this makes. The agent orchestrates document movement through configurable BPMN workflows aligned to the TMF Reference Model v3.3.1 (250 artifacts across 11 zones), enforcing review, approval, and QC steps with SLA timers, and capturing every routing decision, hand-off, and status change to an ALCOA+ audit trail. Sponsors and CROs get a single, visual system of record for document flow instead of email chains and shared drives.
QA designs approval and QC routes in the BPMN designer, mapping each step to TMF zones, roles, and SLA targets.
Incoming documents enter the engine, which assigns owners, opens review tasks, and starts SLA timers automatically.
Status, bottlenecks, and breaches surface on a live dashboard while every action is logged to the audit trail.
Capabilities
Drag-and-drop BPMN canvas lets QA build routing, review, and approval flows mapped to TMF zones without code.
Configurable due-date clocks trigger reminders and automatic escalation when a review or approval step breaches its SLA.
Workflows are pre-mapped to the 11 TMF zones and 250 artifacts of Reference Model v3.3.1 to enforce expected-document logic.
Every state transition, actor, and timestamp is written to an immutable, ALCOA+ compliant audit trail for inspection readiness.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
It's six weeks to your inspection and you need to prove the TMF stayed complete and timely. The live dashboard shows SLA status per zone in real time, and the ALCOA+ audit trail reconstructs every routing decision and hand-off on demand.
A country-specific document sits unreviewed past its due date. The SLA timer triggers reminders and tiered escalation to the manager automatically, so the artifact doesn't quietly go missing until inspection.
A new ICF version needs parallel QA and medical review before filing. QA models the route on the BPMN canvas mapped to the right TMF zone, and the engine assigns owners and opens tasks instead of an email chain.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Veeva Vault
EDC
Who it's for
An intelligent dump-folder that auto-assigns metadata and files documents to the correct TMF location behind a review-and-approve gate.
Learn moreA review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
Learn moreDocument version control with change tracking, side-by-side comparison, and controlled archive management for the TMF.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
