eRegulatory

eISF binders tied to real roles, real documents, real expirations.

Per-study binders structured on the eISF reference model, with placeholder slots for every expected document, expiration tracking that warns before a lapse, and a completeness score a coordinator can act on.

Binders that know what is missing

Each binder carries the standard section set: protocol and amendments, FDA 1572, delegation log, IRB approvals, ICF versions, financial disclosures, CVs and licenses, training records, lab certifications, monitoring log, notes to file, safety, drug accountability, and enrollment logs.

Placeholder slots for expected documents drive a true completeness percentage
Per-document expiration dates feed an expiring-soon view
Document versioning with Part 11 signatures
Certified-copy ingestion for scans and uploads

A delegation log that cannot drift

The delegation of authority log is generated from actual user roles and grants in the system, so what the log says people may do and what the software lets them do are the same thing.

Delegation entries tied to audited role grants
Grant lifecycle changes update the log automatically

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