VelQuest, Werum offer Lab-to-Plant Data Strategy for Pharma Industry
Technology partnership enables real-time availability of plant and lab data.
Parsippany, NJ, and Hopkinton, MA, April 6, 2010 — Manufacturing Execution Systems (MES) vendor Werum Software & Systems America and VelQuest® Corporation, the developer of the SmartLab™ GMP Lab Execution System/ELN, announced today, a technology partnership that integrates Werum’s PAS-X MES software with the VelQuest SmartLab Automated Quality System platform providing a linkage for a plant-based manufacturing database including critical process parameters and QC lab-based critical quality attributes.
The partnership is a direct result of several Fortune 500 pharmaceutical companies seeking a QbD-based knowledge management platform to understand and ultimately control the relationships and operational impacts of production data with QC data. Through this integrated solution, production plants can actively define and control process improvements for reduced production cycle times and reduced operational costs while insuring the highest product quality.
“Today the life sciences industry faces significant cost, productivity and compliance challenges” says Ken Rapp, President and CEO, VelQuest Corporation “The Werum/VelQuest integration provides a comprehensive solution for aggregating plant and QC lab data sources”. “Our relationship with Werum was initiated at the request of several multi-national pharmaceutical companies engaged with both VelQuest and Werum. With QbD initiatives (including PAT and ICH) in the spotlight for most companies, the integration of quality data and production data is the first step for true QbD control and process optimization.”
“The life science production environment is aggressively moving towards optimization of business processes within a compliant quality system framework. We see many Werum customers seeking a software platform that can solve manufacturing process variability challenges," says Hartmut Krome, president and CEO of Werum Software & Systems America. "Capturing and understanding the correlation between the CQA’s obtained through the QC/QA lab workflows and the CPPs from our PAS-X MES plant workflows is on the critical-path for long term operational excellence in modern pharmaceutical and biotechnology plant operations."
About Werum Software & Systems
Werum is the international leading supplier of Manufacturing Execution Systems (MES) for the pharmaceutical and biopharmaceutical industries. It’s successful and well-established MES product PAS-X is installed at 16 of the world’s top 30 pharmaceutical and biotech companies. The comprehensive range of functions built into PAS-X is the key to quality and compliance and lays the foundation for operational excellence initiatives in the manufacturing and packaging of pharmaceutical products. The company’s MES-related services include consulting, project management, validation support, system integration, training, maintenance, hotline support, and life cycle management. The software provider supplies turnkey, integrated and ready-to-bevalidated Manufacturing Execution Systems. A global network of local Werum offices and carefully selected regional solution partners guarantees reliable on-site support for clients.
Founded in 1969, the IT company currently employs 400 people at its headquarters in Lueneburg, Germany, U.S. headquarters in Parsippany, NJ, and at seven other locations in Germany, France, the United States, Japan, and Singapore. For more information on Werum and PAS-X, visit www.werum-america.com.
About VelQuest Corporation
Founded in January, 1999, VelQuest Corporation provides a suite of configurable off-the-shelf software products to help transition regulated industries from labor-intensive, paper-based operations to automated, efficient systems with greater confidence in compliance than ever before possible.
The SmartLabTM solution uses VelQuest’s electronic Process Management & Compliance (ePMC™) Core Operating System that is an innovative “method-centric” software automation platform designed to provide the foundation for compliance-based activities in the life science markets. The software embraces the FDA’s “cGMPs for the 21st Century: A Risk Based Approach”, ICH Q-10, and QbD initiatives, and supports the company’s SmartLabTM applications for a fully compliant electronic laboratory, and SmartBatchTM electronic batch record system.
VelQuest is a registered trademark of VelQuest Corporation. ePMC, SmartLab, ThinLIMS and SmartBatch are trademarks of VelQuest Corporation. All other trademarks are the property of their respective owners.