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. "
