ValGenesis, Inc., a leading provider of Validation Lifecycle Management software solutions, today announced the worldwide availability of its Validation Automation Engine (VAE) within the latest version of ValGenesis 2.0. This breakthrough software solution will further accelerate validation activities by enabling test case execution through the integration with software testing tools. The VAE meets all regulatory requirements such as FDA 21 CFR Part 11 in terms of audit trail, e-sign and security.

Validation, revalidation and regression testing of software and IT systems are mandated by regulatory bodies to ensure functionality, performance and to continuously maintain compliance status as changes occur. However, manually maintaining these processes is expensive and labor-intensive. VAE automates regression testing and revalidation requirements without the need for additional resources. The automated test engine in ValGenesis will significantly reduce validation costs and time for software and IT systems.

Siva Samy, Ph.D., ValGenesis's Chief Product Strategist, stated: "We are excited about the impact of leveraging test automation tools through ValGenesis for software validation requirements. Besides allowing regulated life science companies to improve upon validation processes, it provides quicker ROI and faster 'ready for service' implementation of commercial-off-the-shelf software applications (ERP, LIMS, DMS, QMS etc.) by reducing the validation effort from months to days. The ValGenesis system with VAE provides software vendors the opportunity to reduce the validation cycle time of their software installations by at least 80%, which will enable software vendors to become more competitive in their market segments." Samy further stated, "The many benefits of VAE in ValGenesis include time and cost reduction, greater consistency, enhanced agility and increased compliance in the corporate validation process."