Software optimizes validation life cycle management.
July 8, 2008 -
Through fully electronic process, ValGenesis v2.0 lets users manage entire validation life cycle. Web-based, scalable, multi-site solution enforces consistency and enhances compliance in corporate validation process. Granted 360į visibility of validation status, users can identify bottlenecks. Centralized solution also offers functionality for requirements management, traceability matrix capability, risk assessment, offline validation execution, workflow design, and collaboration.
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|Original Press release |
47012 Mission Falls Court, Suite 218
Fremont, CA, 94539
ValGenesis, Inc. Announces Worldwide Release of Validation Life Cycle Management System - ValGenesis 2.0
FREMONT, Calif., June 26 -- ValGenesis, Inc., a leading provider of Enterprise Validation Management software solutions, announced the worldwide availability of ValGenesis 2.0, the latest version of its breakthrough Web-based, multi-site, scalable validation life cycle management and automation product.
Life science companies implementing the ValGenesis software suite can efficiently manage the entire validation life cycle and move securely from manual, paper-based validation processes to a 100 percent paperless, fully electronic validation process. ValGenesis enforces consistency and enhances compliance in the corporate validation process. Users see a holistic view of a company's validation status and are able to identify bottlenecks, reducing validation cycle time and cost by 40 to 50 percent.
An out-of-the-box solution, with template-driven rapid implementation methodology requiring less overall implementation and validation time, this allows ValGenesis clients' Information Technology and Validation personnel to easily manage other projects in parallel. Among the enhancements in ValGenesis 2.0 are improved requirements management, expanded traceability matrix capability, risk assessment, offline validation execution, workflow design and collaboration through the robust library module.
ValGenesis 2.0 features the ability to implement a single validation system for all corporate/site validation requirements. A centralized deployment provides easier maintenance. By providing 360-degree visibility to the validation process, communication among all cross-functional users is significantly enhanced, while internal and external audit preparation time is reduced by 90 percent. End-users can easily personalize the web-based interface to their needs and interest.
"ValGenesis 2.0 includes substantial technological advancements, enhances the team-based review and can be hosted at a single location and deployed globally in order to address our customers' increasing need for collaboration in today's stringently regulated marketplace," said Siva Samy, PhD, ValGenesis Chief Product Strategist. "We have incorporated several new features and enhancements based on recommendations from our customers which allow our new customers to fully address their core validation requirements and expedite the validation process while remaining fully compliant with industry regulations." He added, "This version introduces the first phase of our new integration initiative. We've partnered with leading companies in the content management and ERP sectors to provide fully integrated solutions." Samy said, "We are particularly excited about the potential for significant savings to our clients using this version's global validation capabilities in which reviewers, approvers and engineers (developers and testers) can share and review information from different locations simultaneously."
ValGenesis offers an innovative software platform that serves as the foundation for compliance-based validation life cycle management in regulated companies. ValGenesis is the first Enterprise application to automate the validation life cycle of GxP systems and to provide 360-degree visibility to the corporate validation process. ValGenesis is designed to fully conform to FDA 21 CFR Part 11 compliance requirements. Through an industry peer review committee, the Parenteral Drug Association (PDA) awarded ValGenesis the prestigious New Innovative Technology award.
For more information, visit ValGenesis's web site at http://www.valgenesis.com/.