FREMONT, Calif., Feb. 16 ValGenesis, Inc., a world-class leading provider of Validation Lifecycle Management (VLM) software solutions, today announced that Shire HGT has implemented ValGenesis software as its platform for validation process management.
Shire HGT had been seeking a robust validation management software solution to replace its in-house developed system. Upon completion of their evaluation, Shire HGT determined that ValGenesis offered significant improvement to the current validation process in terms of increased efficiency, reduction in validation lifecycle times, improvements in regulatory compliance as well as a holistic view of site validation status, making ValGenesis the system of choice. Given ValGenesis' innate ability to uncover bottlenecks in the validation process in real time, its management and resolution expedites the validation process even further. ValGenesis was configured to meet more than 95% of Shire's requirements out-of-the-box and was implemented, validated and put into production on time. The ValGenesis Rapid Implementation Methodology also helped the information technology and validation experts at Shire manage other projects simultaneously. In addition, the flexibility, web services and scalability tools built into the core solution of ValGenesis software easily integrates with other software applications such as SAP, Oracle ERP, Documentum, SharePoint, SmartSolve, Trackwise, etc. These interfaces provide a framework for a closed loop electronic corporate-quality system platform.
"We had evaluated various options to manage our validation process electronically and ValGenesis was a clear choice for Shire based on the process and functions that are pre-built into the solution," said Chris Mansur, Validation Manager, Shire HGT. "ValGenesis' system is unique because the ValGenesis implementation team clearly understood our vision and requirements and configured the system to meet our specific validation process requirements, especially the automating of our comprehensive smart validation document numbering system and workflow. We expect a significant improvement in our validation process in terms of consistency and in the reduction of the validation cycle time. We also expect the ValGenesis software solution to help us implement and enforce the validation standards and procedures that are typically buried in validation master plans, SOPs and policy documents. ValGenesis' dedicated implementation team helped us implement the system in a very short period of time to meet the implementation target date."
Commented Dr. Siva Samy, ValGenesis' Chief Product Strategist: "Shire is a rapidly growing global specialty biopharmaceutical company and proactively addresses this growing need by automating critical areas including validation processes. ValGenesis is known for helping global companies such as Shire to manage the validation process electronically, reduce the validation cycle time, and enforce consistency and compliance in the corporate validation process. We are very pleased to partner with Shire by expanding on the capabilities of the system to meet Shire's validation lifecycle management needs."
ValGenesis is an innovative software platform designed to provide the foundation for compliance-based validation activities in life science companies. ValGenesis is the first Enterprise application to automate the corporate validation lifecycle and to track the Validation Inventory. Through an industry peer review committee, The Parenteral Drug Association (PDA) recognized ValGenesis by awarding it the very prestigious New Innovative Technology award for the year 2005. ValGenesis is designed to be fully compliant with U.S. FDA 21 CFR Part 11 compliance requirements. For more information, visit the ValGenesis Web site at http://www.valgenesis.com.
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CONTACT: Mike Beaudro, Marketing Manager ValGenesis, Inc. +1-510-445-0505 [email protected]
SOURCE ValGenesis, Inc.