Documentum for Life Sciences

OpenText Documentum for eTMF

Remove complexity and risk from clinical trial processes and document management

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Overview

See how to optimize clinical trial documentation management with OpenText

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.

Why choose Documentum for eTMF?

  • Flexible deployment

    Run anywhere with cloud-native software that offers the choice to deploy on-premises, in a hybrid environment or in the cloud.

  • Ensured compliance

    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.

  • Easy upgrades

    Leverage containerized architecture to easily upgrade and access new features, capabilities and updates.

How Documentum for eTMF can benefit business

Discover the advantages of using Documentum for eTMF.

Read the overview

  • Speed trial setup

    Leverage reusable templates to quickly set up trials and ensure consistency for product, trial, country and site-level artifacts.

  • Be audit-ready

    Simplify audit preparation with clinical documents and records lifecycle management and auditor-specific views that provide access to required information only.

  • Minimize compliance risk

    Link content in a single, authoritative source for accurate, complete and compliant regulated documentation, eliminating noncompliant workarounds and manual re-work.

  • Improve user experience

    Customize information views with modular layouts and replace placeholders with completed content and associated detailed audit trail.

Features

  • File-planning templates

    Streamlines and automates file planning and workflows to ensure regulatory packages are complete and ready for Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approval.

  • Realtime progress tracking

    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.

  • Seamless collaboration

    Easily collects and synchronizes sponsor, site and CRO trial documentation with workflows and security models that enhance collaboration and productivity.

  • Content linking throughout drug lifecycle

    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.

Take advantage of OpenText and partner services

Deployment

OpenText offers deployment choice and flexibility for Documentum for eTMF.

Professional Services

OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.

Partners

OpenText helps customers find the right solution, the right support and the right outcome.

Training

OpenText Learning Services offers comprehensive enablement and learning programs to accelerate knowledge and skills.

Communities

Explore our OpenText communities. Connect with individuals and companies to get insight and support. Get involved in the discussion.

Documentum for eTMF resources

Digital technologies for clinical trials: Toward faster time to market

Read the position paper

Managing essential clinical trial documentation for Life Sciences

Watch the video

What’s new in OpenText Life Sciences solutions

Read the blog

How can we help?