OpenText™ Documentum™ for eTMF allows organizations to plan, collect and maintain essential clinical trial documentation. As part of OpenText™ Documentum™ for Life Sciences, Documentum for eTMF reduces the complexity and risk for sponsors and CROs while ensuring fast, secure access to documentation during and after trials.
Run anywhere with cloud-native software that offers the choice to deploy on-premises, in a hybrid environment or in the cloud.
Comply with GCP and FDA 21 CFR Part 11 with audit trails, access and version control and lifecycle management, and enforce approval processes with automatic assignments.
Leverage containerized architecture to easily upgrade and access new features, capabilities and updates.
Discover the advantages of using Documentum for eTMF.Read the overview
Leverage reusable templates to quickly set up trials and ensure consistency for product, trial, country and site-level artifacts.
Simplify audit preparation with clinical documents and records lifecycle management and auditor-specific views that provide access to required information only.
Link content in a single, authoritative source for accurate, complete and compliant regulated documentation, eliminating noncompliant workarounds and manual re-work.
Customize information views with modular layouts and replace placeholders with completed content and associated detailed audit trail.
Automates quality checks for inappropriate documents, unclear images and missing sign-offs to find and complete missing documents and offers interactive dashboard reports for actionable insights into process inefficiencies.
Links and shares content from clinical, regulatory and quality domains automatically so users can plan, create and locate submission-ready content over the full product lifecycle from development to commercialization.
OpenText offers deployment choice and flexibility for Documentum for eTMF.
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