News Summary: Suite, which includes four complementary solutions – electronic trial master file (eTMF), research and development (R&D), submission store and view, and quality and manufacturing (Q&M) –supports organizations with combined pharmaceutical and medical device offerings Provides Clinical, Regulatory, and Design History File/Device Master Record document enhancements for full lifecycle support, from design to production manufacturing Increases usability and exceeds good practice regulatory requirements when managing controlled paper copies Extends eTMF capabilities for more granular insight, and provides quality control features and new dashboard metrics to ensure optimal quality of trials Delivers simultaneous eTMF support for both the 2.0 and 3.0 DIA eTMF Reference Models Offers an expanded R&D inventory to help speed regional regulatory submissions and ensure alignment with regulatory guidance Full Story: #Dell #EMC™ Enterprise Content Division (ECD), a leader in the enterprise content management industry, today announced the general availability of EMC® Documentum® for Life Science, which now includes new capabilities for supporting medical device documentation in addition to pharmaceutical documentation. The latest version focuses on driving efficiency, enhancing usability and improving visibility and insight across clinical, regulatory and quality solutions. Enhancements include the addition of a harmonized medical device solution, expanded best practices R&D inventory, support for multiple DIA eTMF reference models, an enhanced, flexible controlled print model and increased capabilities for the eTMF solution. "Life Science organizations are leveraging enterprise content management as part of a holistic strategy that embraces a broader organizational approach to transformation," said Dr. Alan Louie, PhD., Research Director, IDC Health Insights. "The Dell EMC Documentum for Life Sciences solution is well aligned with this market opportunity, providing harmonized data models and document inventories and processes across the clinical, regulatory and quality domains." "Many Life Science organizations have difficulty implementing a cohesive solution for both pharmaceutical and medical device documentation, since available systems are often too complex or cost-prohibitive for smaller businesses," said Andy Crowne, Vice President of Industry Solutions and InfoArchive. "EMC Documentum for Life Sciences solution suite brings both options together in a single repository, giving companies of all sizes the choice and flexibility of implementing a single medical device solution or deploying R&D and Q&M independently to align with business functional areas."
No comments:
Post a Comment