OpenText™ Documentum™ for Life Sciences is a set of comprehensive, purpose-built solutions to transform how organizations access, manage and share regulated content. Leveraging agency guidance and industry leading practices, Documentum for Life Sciences breaks down information silos, reducing complexity while unifying and streamlining processes.
Leverage a containerized architecture to easily upgrade and get access to new features, capabilities and updates, whether on-premises, in a hybrid environment or in the cloud.
Use multiple solution modules in a single repository for cross-domain searches and linking, eliminating unnecessary importing and exporting between systems.
Demonstrate FDA 21 CFR Part 11 compliance with audit trails, lifecycle management, access and version control and enforce approval processes with automatic assignments.
Leverage industry-standard business processes for document taxonomies, lifecycles and workflows for pharmaceuticals and medical devices that enforce corporate document controls while enhancing local productivity.
Collaborate and reuse content and processes with internal and remote employees, authorized partners and other third parties without compromising security or compliance.
Integrate with existing infrastructure, on-premises systems and in any cloud, including quality management, learning management and enterprise resource planning systems.
Choose from a suite of purpose-built document management solutions for Life Sciences that leverage industry guidance and best practices. Link and seamlessly manage documentation to accelerate clinical trials, improve regulatory submission quality and ensure manufacturing process compliance.
Realize operational efficiencies with secure access, fast deployment and flexible upgrades.
Deliver secure, compliant, cloud-based access to content and processes.
Control critical quality documentation, streamline and automate processes with compliance.
Create, review and approve submission documentation faster.
Get a 360-degree view of regulatory activity and improve archived submissions compliance.
Remove complexity and risk from clinical trial processes and document management.