ValGenesis, the innovator and market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), today announced that Varian Medical Systems, the world's leading manufacturer of medical devices and software for treating cancer, has implemented the cloud-based ValGenesis system.
Varian has successfully gone live with ValGenesis to manage its validation lifecycle processes for enterprise software and GxP applications, the first phase of implementation.
Varian Medical Systems had been seeking a software solution to assist in maintaining the validation status of GAMP 5 Category 4 and 5 software systems, such as the SAP enterprise software system.
ValGenesis VLMS was selected for its industry-specific functionality offering the potential for dramatic improvements over the company’s current validation maintenance processes.
ValGenesis provides a holistic view of the change control process and associated validation deliverables. All of the validation activities are accessible in real-time from a convenient dashboard within ValGenesis, which provides a direct line to validation tasks, inventory, work in progress, calendars, projects, reports, and a 360-degree view of GxP systems and assets by site.
The validation-centric Application Lifecycle Management function in ValGenesis enables users to manage individual requirements and then dynamically create executable summary documents by consolidating all the impacted items from a range of requirements and test plan documents. The consolidated summary can be routed through a single approval process with all deliverables to significantly reduce the cycle time for compliant change control and validation.
Accessing the application through the enterprise-ready validated ValGenesis Cloud helps companies to implement and deploy the system rapidly with less investment. The ValGenesis Cloud solution is hosted in an SSAE 16 SOC 2 Type 2-certified data center, the most advanced infrastructure available.
Through an independent evaluation, the hosted private ValGenesis Cloud has received a Service Organization Control 2 (SOC 2) Type 1 certification under AT Section 101.
"We knew that by starting with electronic validation for enterprise process-related software, we were tackling the tough part first in a phased implementation," said Larry Lindberg, Varian’s Manager of IT Validation, Planning, Procurement, Security and Data Privacy. "