Through a Closed-loop Process, the ValGenesis System Enables Regulated Life Science Companies to Monitor Real-time Validation Status of GxP Assets in SAP
Regulated Life Sciences companies are compelled to plan, implement and document validation activities for instruments, equipment, computer systems, processes and the methods used for product manufacturing, as a way of meeting regulatory requirements. Predominantly these processes are managed manually in a paper-based process. ValGenesis manages all these processes 100% electronically, in addition to ValGenesis enhancing compliance, improving consistency, significantly reducing validation cycle time and removing any inefficiencies that plague paper-based validation processes.
Regulated manufacturing companies also use SAP for Manufacturing Processes, Plant Maintenance and Asset Management, and as such must have real-time validation status of GxP systems including instruments, equipment, computer systems etc., both during manufacturing and maintenance stages. Currently, these systems are validated and managed largely through a manual, paper-based process, leading to tremendous amounts of information in different formats and storage silos. The validated ValGenesis-SAP connector enables SAP customers to manage their manufacturing process with real time validation status. Through certified integration with SAP NetWeaver, a cornerstone of SAP's Enterprise Services Architecture (ESA), the "Powered by SAP NetWeaver" certification emphasizes how the ValGenesis platform adds significant value to SAP solutions.
"ValGenesis is the ideal complement to SAP's Process Manufacturing Platform," states Siva Samy, Chief Product Strategist at ValGenesis, Inc. "The ValGenesis Validation Lifecycle Management Platform enables organizations to further leverage their existing investment in SAP software. By managing the qualification and validation of all GxP assets in ValGenesis, assets in SAP are successfully maintained with real-time validation status." Samy, further added, "ValGenesis integration with the SAP platform allows corporate leaders to monitor the validation status of any instrument, piece of equipment, software system, or process remotely, and in real time, for any site. Furthermore, the integration can be extended to display the details of any upcoming periodic reviews, revalidation schedule and status of the change requests in the SAP system, so as to better plan production schedules while minimizing downtime. As a result of this integration, ValGenesis looks forward to a strategic partnership with SAP and anticipates providing a robust closed-loop validation framework that meets SAP’s Life Science customer 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
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