Product/Service

Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

Source: EMC Corporation

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Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.

Challenge

Manufacturing departments are increasingly confronted with time-consuming, manual review and approval processes that lead to insufficient control of critical quality documentation. Many IT departments are tasked with identifying ways to improve the overall efficiency and control of quality and manufacturing documents to mitigate the potential risk of consent decree fines and production delays.

Solution

The EMC Documentum Quality and Manufacturing solution (Documentum Q&M), part of the EMC Documentum for Life Sciences solution suite, enables life sciences organizations to control quality and manufacturing documents, automate workflows across the extended enterprise, and ensure compliance with GMP standards.

Documentum Q&M provides an industry-standard, out-of-the-box document taxonomy to help you quickly create documents and search and navigate within them. This includes documents related to Quality and/or Chemistry, Manufacturing and Controls (CMC) based on the DIA reference model, as well as procedures, governance, corporate policies and validation reports.

With Documentum Q&M, you can clearly prove 21 CFR Part 11 compliance through extensive audit trails, access controls (including e-approval and e-signature support), and document distribution, version control and lifecycle management. The solution also supports print-control services and preconfigured, dynamic watermarking and overlays to ensure document security.

Documentum Q&M delivers innovative functionality designed to address the challenges of managing quality and manufacturing documentation—and the benefits of a trusted and highly scalable foundation: EMC Documentum, the life sciences industry standard for enterprise content management. The result is unprecedented efficiency, agility, document control and compliance that's key to getting products to market ahead of the competition. To learn more, visit us at www.emc.com.