EMC® Documentum® Research and Development
Accelerate the creation, review and approval of regulatory submission documentation.
Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you’ve outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.
Many organizations use a document management system to support these activities, or the process is manual. To what extent can you help people do their jobs more quickly—for example, to instantly find the documents they need? How easily can they collaborate on authoring, and how user-friendly is the authoring environment? How quickly can you make changes to support process improvements? In most cases, even the smallest changes to a system or process can result in weeks or even months of delays.
The EMC Documentum Research and Development (Documentum R&D) solution addresses these challenges head on. As part of the EMC Documentum for Life Sciences solution suite, the solution enables you to efficiently manage the creation, review and approval of regulatory submission documentation globally. You’ll not only accelerate the submission process, but also benefit from uncompromised compliance, complete global control of content and secure information sharing across the extended enterprise.
ESSENTIALS
- Ensure submission-ready documentation with all required content elements included
- Streamline review and approval processes using collaborative authoring for simultaneous review, editing and approval
- Boost productivity using a template-based authoring process and an intuitive, easy-to-use interface
- Link content across solutions for consistent, simplified document management and user access
- Clearly demonstrate compliance through extensive audit trails, access control, lifecycle management and version control
- Enable mobile workers to participate in review and approval workflows while on the go
- Leverage a proven, trusted, and scalable cloud-ready platform