We all know developing the next miraculous breakthrough in life sciences is not a drag race. It’s an obstacle course. Life sciences organizations continuously battle shrinking development pipelines, expiring patents, generic competition and heightened regulatory pressures. At the same time, there’s a whole new set of demands being placed to deliver uncompromised control, access and visibility to the organization’s most critical content and information while meeting Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) requirements and ensuring inspection readiness at all times.
Thanks to EMC, life sciences organizations can fast track through the obstacles with EMC Documentum for Life Sciences Solution Suite 3.0, a fully integrated, purpose – built solution suite.
Today, I’m excited to share new innovations to help life sciences organizations accelerate the creation, review and approval of regulatory submission documentation; improve user productivity and operational efficiency; and ensure on-going inspection readiness and compliance.
New EMC Documentum Research & Development (Documentum R&D)
As part of the Solution Suite, Documentum R&D is specifically designed to help life sciences companies deliver new products to market faster by streamlining the regulatory submissions process. It includes a robust content repository to manage what can be millions of documents, while maintaining compliance with regulatory requirements. Now, organizations can eliminate information silos, achieve global content control and ensure all documents are submissions ready. That’s not all. Documentum R&D also provides unique capabilities to help:
- Improve author productivity with template-based processing
- Streamline review and approval through collaborative authoring
- Quickly find submission-ready documentation and ensure uncompromised regulatory
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We also enhanced Documentum Electronic Trial Source File and EMC Documentum Quality and Manufacturing solutions to include role-specific workspaces, externalized access, and enhanced mobile support. And together with Documentum R&D, the Solution Suite enables organizations to:
Accelerate creation, review and approval of regulatory submission documentation and eliminate information silos. Simply create, review and link submission-related documentation residing in any solution within the EMC Documentum for Life Sciences solution suite.
Improve user productivity and operational efficiency with role-specific views and tailored feature sets. Pre-configured business rules provide a simplified way of accessing, creating, reviewing, approving and sharing content – even while on the go.
Ensure on-going inspection readiness and compliance with an enhanced security model to provide external parties simple and direct access to authorized information. Inspectors have a dedicated, intuitive interface that allows them to easily access only audit-required documentation, simplifying their training.
EMC understands this market. In fact, EMC Documentum has been proven and trusted in the life sciences industry for 20+ years. And according to an internal survey:
- 94% of customers chose Documentum because it is a proven, trusted platform for regulated content management.
- 88% of customers cite the ability to achieve better scalability and performance with Documentum.
- 82% of our life sciences customers say that they can better respond to business needs with Documentum.
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