Upon completion of their evaluation, Shire HGT has determined that ValGenesis offered 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.
The ValGenesis Rapid Implementation Methodology also helped the information technology and validation experts at Shire to 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. These interfaces provide a framework for a closed loop electronic corporate-quality system platform.
Chris Mansur, validation manager of Shire HGT, said: 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 an 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 short period of time to meet the implementation target date.
Siva Samy, chief product strategist of ValGenesis, said: Shire is a 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 pleased to partner with Shire by expanding on the capabilities of the system to meet Shire’s validation lifecycle management needs.