By Clinical Informatics News Staff

October 24, 2016 | Dell Technologies Enterprise Content Division (ECD) announced the general availability of EMC Documentum for Life Sciences 4.2.
The EMC Documentum for Life Sciences solution suite is designed to break down information silos to transform how organizations access, manage, and share regulated content. The solution provides a single source of accurate, complete, and compliant information that reduces risk and helps bring high quality, safe products to market faster and at a lower cost. 
 

“Life Science organizations are leveraging enterprise content management as part of a holistic strategy that embraces a broader organizational approach to transformation,” said Alan Louie, Research Director, IDC Health Insights, in a statement. “The Dell EMC Documentum for Life Sciences solution is well aligned with this market opportunity, providing harmonized data models, document inventories, and processes across the clinical, regulatory, and quality domains.” 


Due to a lack of both global, harmonized industry standards for medical device documentation and requirements for electronic submissions by governing agencies, few vendors provide out of the box documentation support for medical device management. As a result, companies often must deal with the limitations that come with paper-based systems, including process inefficiency and a lack of traceability and control.

EMC Documentum for Life Sciences 4.2 provides a solution that manages quality and regulatory documentation for both medical devices and pharmaceuticals. It a harmonized global, standard document inventory and processes across regulatory and manufacturing, a complete, standard framework for creating and managing global medical device documentation.

The Life Sciences 4.2 release focuses on 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 electronic trial master file (eTMF) solution.