Sanofi Pasteur Standardizes on Configurable, Document Control Foundation, Speeds Time to Market and Simplifies Compliance with EMC Documentum D2
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% 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.
Alain Delpuech, VP Information Solutions, Sanofi Pasteur
“Sanofi Pasteur is committed to delivering superior, innovative vaccines for the prevention and treatment of disease. By standardizing on the Documentum Life Sciences solution, we’re able to provide a unified document control foundation for compliance that spans across the vaccine development lifecycle and extended enterprise. This helps us ensure process quality, reduce risk and drive innovation to keep our business highly competitive.”
EMC Corporation is a global leader in enabling businesses and service providers to transform their operations and deliver IT as a service. Fundamental to this transformation is cloud computing. Through innovative products and services, EMC accelerates the journey to cloud computing, helping IT departments to store, manage, protect and analyze their most valuable asset – information – in a more agile, trusted and cost-efficient way. Additional information about EMC can be found at www.EMC.com.
About EMC Documentum For Life Sciences
EMC’s Documentum-based Life Sciences solutions deliver a unified, configurable document control platform for compliance with industry regulations. The foundation of these solutions include the Documentum Enterprise Content Management platform, Documentum D2 for configuration and intuitive user interfaces, implementation and migration services. The D2 configuration technology enables auditing, reporting and e-signature support for compliance, lifecycle management and document control services, and industry-specific modeling capabilities all designed for Life Sciences.
About EMC Documentum D2
Documentum D2 simplifies the user experience for Documentum and enhances the productivity of knowledge workers by easily tailoring their user experience for their specific requirements. It accelerates time-to-value through the power of configuration for building and delivering content centric solutions to meet the needs of the business. In addition, administrators now have consistency of ECM rules and policies through this simplified information management approach based on configuration.