eTMF
Average cost savings of 62% compared to other eTMFs.
Fountayn’s eTMF is Part 11 compliant document repository with compliant audit logs and standardized terminology the eTMF Reference Model. Documents, workflows, and medadata are version controlled, centrally managed, and indexed. Users can be assigned roles for secure access. It is configurable by moving, copying, and deleting. Documents are searchable and exportable in formats conforming to the RM.
Switching from another eTMF to Fountayn is easy because site personnel can send, receive, and approve eTMF documents from EDC dashboards therefore significantly reducing the onboarding process.
Regulatory inspection friendly with audit settings to tailor the viewable documents to information necessary and data definitions. Document data and workflows have settings for Quality Control, Certified Copy, Document Request, and more.
eTMF is closely integrated with Fountayn’s EDC to allow a seamless experience on platform without additional logins. Permissions can be grated to EDC users within the EDC dashboard allowing document sharing, upload document requests, workflow participation, and other features from eTMF.
Fountayn’s eTMF is priced at a fraction of what other eTMFs cost. Schedule your demo meeting with us to find out more.
SWITCHING IS EASY WITH LITTLE ONBOARDING
Users don’t need to transition or learn a new eTMF system because they can access eTMF through the EDC dashboard. Central manager roles at the Sponsor or CRO determine site user access.
FDA CFR 21 PART 11 COMPLIANT eTMF SYSTEM
Fountayn’s eTMF system is fully Part 11 compliant and validated.
Switching provides a 62% cost savings on average when compared to other eTMF systems
