Bayer implements ValGenesis validation process management software at Berkeley and Emeryville sites

ValGenesis, Inc., a world-leading provider of Validation Lifecycle Management (VLM) software solutions, today announced that Bayer HealthCare AG has implemented ValGenesis software as their platform for validation process management at their Berkeley and Emeryville sites.

The Quality Validation unit at Bayer HealthCare in Berkeley, led by Elizabeth Bramhall, set out to examine and improve validation activities at the site. The overarching goal was to create leaner, more efficient processes in the validation organization.

Historically, validation activities at the Berkeley site have been performed utilizing a time-consuming paper-based system. Recognizing that this system is highly susceptible to redundancies and inconsistencies, Bramhall and her team wanted a system that would centralize validation activities, providing opportunities for increased productivity and streamlined processes.

Within three months, the team rolled out ValGenesis, a fully compliant electronic-based system, designed to track validation inventory, streamline validation processes, increase efficiency and ensure compliance.

Benefits of ValGenesis from Bayer's Perspective

• Maintains and enforces consistency in the corporate validation methodology
• Through templates and controlled workflows, reduces the risk of non-compliance while at the same time enforces compliance in the corporate validation process
• Provides real-time validation status and eliminates excessive time for tracking validation status and documents
• Audits with readily available electronic validation data and protocols
• Reduces the validation cycle time by 40-50%
• Eliminates the risk of missing periodic reviews and revalidation schedules
• Turns the corporate validation process into a 100% paperless validation system

With the robust flexibility, web services and scalability tools built into the core solutions, ValGenesis software will easily integrate with other software systems such as SAP, EMC Documentum, SharePoint and Quality Management systems, etc. These interfaces would provide a framework for end-to-end closed-loop electronic corporate quality system platforms.

"Traditional validation activities with paper-based validation processes stifle innovation, cause compliance risks and compromise life science firms' ability to bring products to the market on time. ValGenesis helps all regulated manufacturing companies to manage the validation process electronically, reduce the validation cycle time, and enforces consistency and compliance in the corporate validation process," says Siva Samy, ValGenesis' Chief Product Strategist. "The scalability and configurable nature of ValGenesis helps global companies implement at a single site, or department level, and expand globally. ValGenesis allows corporate quality leaders to monitor the validation status of any instrument, equipment, software system or process remotely and in real time for any site. In addition, it enables multi-site companies to reuse validation protocols globally across the sites, which reduces the validation cost and cycle time with improved consistency. We look forward to being a strategic partner and providing a robust framework to meet Bayer's Validation lifecycle management needs."