EMC Corporation recently announced that Sanofi Pasteur, a world leading vaccine manufacturer producing more than 1 billion doses of vaccine per year, has deployed EMC Documentum D2, enabling the company to accelerate time-to-value through the power of configuration.

Documentum D2 is a content management application with a modern, configurable and intuitive user experience for the EMC “Documentum” platform, and a key component of the Documentum for Life Sciences solution. This solution has enabled Sanofi Pasteur to transform business, and modernize its content management system into a unified, document control and compliance infrastructure for managing mission-critical regulated content.

Customer Benefits of the EMC Documentum Life Sciences Solution: Simplified IT management. ”Flexible lifecycles, workflow automation, and advanced configuration and usability enables Sanofi Pasteur’s IT staff to focus on innovation and business-critical projects instead of addressing technical issues “providing Sanofi’s IT team a 4x boost in productivity; Cost Savings.” Leveraging pure application configuration vs. internal development enabled Sanofi Pasteur to eliminate need for custom coding and reduce validation costs resulting in a 20 percent TCO savings; Improved process quality and collaboration.” Unified architecture built on DIA EDM reference model, ensures process consistency, enables collaborative authoring, and seamless document control across internal and external boundaries including R&D, quality and manufacturing, clinical development, and contract/clinical research organizations (CROs); Reliable Compliance.” Automated enforcement of policies, reporting, e-signature support, and full audit trails enable compliance with global regulations and industry standards such as FDA 21 CFR Part 11, GxP, and TMF reference models.

Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases across 12 globally dispersed production sites, requiring compliance with local and international quality and regulatory procedures.

Sanofi Pasteur turned to EMC to gain document control and provide a common framework enabling secure collaboration, efficient audit management, and scalability across its global operations. Working with the EMC Information Intelligence Group’s Services organization, Sanofi established an enterprise-wide Global Electronic Document Management Policy to ensure process quality, consistency and control across document lifecycles while corresponding to GxP standards.

This approach enabled Sanofi Pasteur to extend its document management strategy and support electronic Trial Master Files (eTMF) in compliance with good clinical practices and applicable regulatory requirements for greater clinical efficiency, real-time access and collaboration with regional sites and CROs.