Risk-based oversight, added to eTMF Connect
Score the risk. Scope the review. Document the outcome.
Every review starts with a reason, not a guess. Risk Score and Risk Impact show you where to look. Study Oversight lets you scope, run, and close the review inside eTMF Connect, without a spreadsheet.
FDA 21 CFR Part 11
EudraLex Volume 4 Annex 11
SOC 2® Type I
Audit support
ISO 9001:2015 QMS Alignment
GDPR
Your TMF, inspection ready
eTMF Connect gives scaling life sciences teams automated workflows, pre-configured TMF structures, and real-time completeness tracking through the eTMF Navigator. Study Oversight and Risk Management are available as an add-on for teams holding their eTMF on eTMF Connect.
They extend the same system: Risk Score and Risk Impact draw on the completeness and timeliness data already tracked in your TMF, so review decisions connect directly to the documents behind them, without a separate tool or export.
Every review decision on record, automatically
Score the risk, scope the review, document the reasoning. Every study gets its own review, built the same way each time.
Score the risk, scope the review
Find what matters, fast
Scope, decision, and outcome, always connected
Why you need Oversight
Every study tracked a different way. None of it documented.
Oversight happens outside your system of record: a spreadsheet, a judgment call, a meeting nobody wrote down. The signal exists. The reason a review happened rarely does, and this gap is exactly what inspectors look for.
What this gets you
The decision trail, already assembled
Find what matters, fast
Scope, decision, and outcome, always connected
Built for risk-proportionate oversight
Security & compliance
Montrium protects customer data through vetted personnel, ongoing security training, and regular testing, including penetration testing, vulnerability scanning, and code analysis. Cloud environments run on Microsoft Azure with data isolation, encryption in transit and at rest, and continuous monitoring aligned with SOC 2 standards.
SOC 2® Type I
FDA 21 CFR Part 11
GDPR
.png)
ISO 9001:2015 QMS alignment
CSA Star Enabled Solution
EudraLex Volume 4 Annex 11
See Risk Score, Risk Impact, and Study Oversight together
Book a demo to see how Risk Score, Risk Impact, and Study Oversight work inside eTMF Connect.
Resources for your TMF team
R3 compliance, built-in: Risk-based oversight with eTMF Connect
Discover how eTMF Connect helps teams turn risk signals into documented, inspection-ready oversight workflows aligned with ICH E6(R3).
Building a Risk-based TMF Management Framework
In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management.
Frequently asked questions
Find answers about Montrium product and services, implementation, and how it works for your organization.
