FREMONT, Calif. – Dec. 8, 2014 –
ValGenesis, Inc., 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. “Prior to this effort, we were doing well in validating newly implemented applications, but we wanted to improve upon the laborious manual processes involved in the ongoing maintenance of validation status. ValGenesis has provided the kind of collaborative partnership we were hoping for as we worked together to configure the system. The validated ValGenesis Cloud solution should address our needs and the validation process requirements specific to Category 4 and 5 software systems with a complex and continuous change request process.”
With Phase I of the implementation at Varian Medical Systems completed, 100% of changes made in the process of maintaining the validation status of enterprise and process-related software systems will be managed through ValGenesis. By automatically enforcing validation standards and procedures that lie within validation master plans, standard operating procedures (SOPs), and policy documents, ValGenesis has delivered improvements in consistency and reduced the cycle time. The ValGenesis solution will eventually be rolled out to manage process, equipment, and other validation processes across the company.
“ValGenesis is known for helping global companies such as Varian Medical Systems to manage their validation processes electronically and is an ideal solution for those requiring consistency across all areas that need to be validated.” said Siva Samy, ValGenesis Chief Product Strategist. “We are so pleased to be working with Varian Medical Systems, a leader in its space with a clear vision for achieving company-wide quality and validation goals. In proactively addressing and automating areas critical to maintaining customer satisfaction and regulatory compliance, Varian is also leading in best validation practices, particularly as they relate to GAMP 5 Cat 4 and Cat 5 software systems. We look forward to our continued work in expanding the capabilities of ValGenesis as the solution is rolled out to other areas.”