Collaboration and Knowledge Management Solutions
- Pharmaceutical companies
- Contract research organizations
- Biopharmaceutical enterprises
- Improve collaboration
- Simplify risk and compliance
- Share information seamlessly
The life sciences industry has undergone radical changes in the business model. The industry is moving towards a more virtual, lean organization that relies more heavily on partners and service providers to bring new products to market.
As competition has increased and product pipelines have dwindled, there is a greater need to enable innovation while managing costs such as one-off, labor-intensive methods of collaborating on documents.
Current processes and applications for managing research and development (R&D) and regulatory submissions documents are no longer effective in today’s model and are costly to maintain. Life science businesses need a way to quickly collaborate with internal and external parties and reduce cycle times for document authoring, review, and approval.
EMC offers a collaboration environment that can start with a Microsoft SharePoint-EMC Documentum collaborative authoring solution. Based on leading industry requirements and processes, this framework can jump-start your implementation efforts.
We start with strategy and planning to mobilize the initiative, clarify objectives, and develop your roadmap for improving collaboration. Our solution enables you to meet global regulations, guidelines, and industry standards including the Electronic Common Technical Document (eCTD) standard and other submissions guidance, Good X Practice (GxP), SAFE-Biopharma, U.S. Food and Drug Administration (FDA) Code of Federal Regulations (CFR) 21 Part 11, Darwin Information Typing Architecture (DITA), and the Drug Information Association (DIA) Entity Data Model (EDM) reference model.
EMC Collaboration and Knowledge Management Solutions enable your organization to increase collaboration and innovation while reducing time to market and maintaining compliance in today’s complex life sciences environment.