.webp)
Stop chasing documents - start proving TMF integrity
eTMF cuts down on manual filing like which document was uploaded, where it was filed, which version is approved, who evaluated it, and when it was ready for inspection.
eTMF lets sponsors, CROs, and clinical teams keep a Trial Master File that is ready for an audit. eTMF automatically classifies, files, and routes data for quality control and approval when sites upload important documents or protocol changes are made. This closes TMF gaps faster and makes it easier to see what's going on across studies, nations, and vendor partners. It's designed to make being ready for an inspection a habit.
- •Tracking the completeness of the TMF and the readiness of the milestones in real time.
- •Controlled versioning with a way to track reviews and approvals.
- •TMF proof that is ready for an audit for sponsors, CROs, and inspectors.
eTMF Features
Automated filing, QC workflows, and inspection-grade traceability designed for regulated clinical trials.
Auto-Filing & AI Document Classification
Automatically classify uploads into the correct TMF zone, artifact, and trial structure with metadata extraction to minimize manual errors.
Milestone-Based TMF Completeness Tracking
Track completeness by study, country, site, and milestone with dashboards that highlight missing artifacts and inspection readiness status.
Configurable QC Workflow Automation
Route documents through configurable QC steps with reviewer assignments, checklists, electronic sign-offs, and exception handling.
Version Control & Controlled Document History
Maintain full traceability across drafts, final versions, superseded files, and amendment-linked documents with time-stamped histories.
Missing Document Alerts & Gap Remediation
Detect and notify stakeholders of missing artifacts early, auto-generate follow-ups, and log remediation actions for audit evidence.
Sponsor & Inspector Review Portals
Provide secure, permissioned sponsor and inspector views with exportable, inspection-ready bundles and controlled access to sensitive artifacts.
Site & Vendor Submission Standardization
Standardize uploads with templates, validation checks, and role-based controls to speed site and vendor document intake and reduce rework.
Integration & Data Flow
Seamless bi-directional connectors for CTMS, EDC, eConsent, safety systems, and vendor platforms so TMF evidence stays synchronized without manual reconciliation.
Compliance,
Security &
Validation Readiness
Built for regulated life sciences workflows with role-based access, secure audit trails, and electronic record controls designed to support GxP requirements and inspection expectations. We combine strong controls (roles, permissions, audit trails, Data integrity) with AI-assisted automation that reduces manual effort while keeping evidence complete.
- •Audit trail, traceability, and evidence-first workflows to support your validation/assurance approach (URS → risk → security test evidence).
- •Access control, segregation of duties, and configurable permissions.
- •Configurable workflows to match your SOPs and quality system.
Want to accelerate your rollout? We can provide a validation-ready evidence framework aligned to your SOPs.
eTMF Use Cases
Designed for TMF completeness, sponsor oversight, inspection readiness, and global documentation control.
Inspection Readiness Automation
Maintain a continuously complete TMF with automated filing, QC, and audit-ready proof.
Sponsor Review & Oversight
Provide controlled sponsor access to real-time completeness and document approval status for faster reviews.
Site Document Collection & Standardization
Standardize site uploads, reduce missing documents with automated reminders, and validate submissions at intake.
QC & Compliance Workflow Control
Enforce consistent QC steps across studies, countries, and vendors with traceable approvals and exception logs.
Milestone-Based Readiness Reporting
Report readiness for study start-up, interim review, database lock, and close-out with downloadable inspection bundles.
Vendor Deliverable Management
Centralize vendor deliverables, map them to TMF artifacts, and maintain traceability across external partners.
Frequently Asked Questions About Smart-eTMF
Smart-eTMF Auto-Pilot is an AI-powered eTMF that automates document classification, filing, QC workflows, and completeness tracking to keep your TMF inspection-ready.
It uses milestone-based dashboards and missing-document alerts to surface gaps early and automate follow-ups, speeding gap closure before audits.
Regulators expect version-controlled documents, QC approvals, timestamps, and complete artifact traceability—all provided by Smart-eTMF's audit trails.
Yes — Smart-eTMF supports bi-directional integration with CTMS, EDC, eConsent, safety systems, and vendor platforms to keep evidence synchronized.
Yes — built for global programs with role-based access, country/site hierarchies, and centralized oversight across sponsors, CROs, and vendors.
Ready to Automate TMF Management with Audit-Ready Evidence?
Get inspection-ready eTMF evidence, auto-classification, QC workflows, and real-time completeness visibility across your trials.