Solutions · Regulatory Affairs & Quality Assurance
You know the TMF has been drifting since the last audit — you just don't know exactly where. Health1st AI keeps an electronic Trial Master File that files and classifies itself to the TMF Reference Model, with 21 CFR Part 11 e-signatures, complete audit trails, and Computer System Validation documentation built in — so ready is the resting state, not a six-week sprint.
What you own
We know how this feels
Every inspection notice starts the same quiet dread: you know gaps have crept into the file, and now you have to find and fix them all before someone else does.
And the part no one says out loud:
Where the agents fit
The grind you just read isn't abstract — each piece of it already has an agent assigned. Here's which one picks up which fight, so you can see exactly where the help lands before you commit to anything.
The pain
Your TMF shouldn't scare you before an inspection
The agent on it
eTMF Workflow AgentA BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
The pain
Filing a document shouldn't be a judgment call
The agent on it
Document Classification AgentAn AI classifier that reads clinical documents and assigns the correct TMF zone, section, and artifact with extracted metadata.
The pain
Fast filing shouldn't mean a mass-upload red flag
The agent on it
Auto-Filing AgentAn intelligent dump-folder that auto-assigns metadata and files documents to the correct TMF location behind a review-and-approve gate.
The pain
A wet-ink scan shouldn't be your approval record
The agent on it
Review, Approval & e-Signature AgentA review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
The pain
No one should work from last month's protocol
The agent on it
Version Control AgentDocument version control with change tracking, side-by-side comparison, and controlled archive management for the TMF.
The pain
An SAE mismatch shouldn't become a reporting failure
The agent on it
Safety Review AgentSAE and SUSAR tracking with automated reconciliation between the EDC and the safety database.
Your agentic workforce
These feature agents map most directly to regulatory affairs & quality assurance. Enable the ones you need, per study and per deliverable, and expand over time.
A BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreAn AI classifier that reads clinical documents and assigns the correct TMF zone, section, and artifact with extracted metadata.
Learn moreAn 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 moreSAE and SUSAR tracking with automated reconciliation between the EDC and the safety database.
Learn moreOutcomes
Quantified targets we build toward with each engagement.
Every output is grounded, reviewed, and inspection-ready
“For the first time the file was already inspection-ready when the notice came, instead of the trigger for a six-week scramble. The gaps surface as they happen, and every AI filing is reviewed and audit-trailed — so I'm not defending a black box.”
Illustrative — representative of the workflows we build toward during our pre-launch pilot.
No pressure, straight answers
The doubts that usually surface before a team like yours says yes — answered plainly, including the places where the honest answer is a limit rather than a promise.
See it run on one of your own studies — no pressure, no obligation, and honest answers, including on the limits. We will walk regulatory affairs & quality assurance through exactly what stays under your control.
