ValGenesis Launches Traceability Matrix and Validation Planner Modules to manage the entire Validation Process electronically and securely to meet Compliance Requirements
Fremont, CA October 04 ,2007, ValGenesis, the pioneer in validation automation and management software for life science companies, announced today the immediate availability of new software modules that take validation processes to new heights. ValGenesis automates the validation process with document development, electronic execution, test case deviations, tracking and scheduling modules. With the addition of new Traceability Matrix and Validation Planner modules, ValGenesis provides end-to-end validation automation and enables a completely paperless validation process.
In that the FDA regulates life science companies, those companies are required to validate processes, software, instruments and equipment used in clinical trials, quality control and manufacturing processes. The new Traceability Matrix and Validation Planner modules are designed specifically to meet the demands of companies dealing with complex validation projects. By implementing the ValGenesis software suite, life science companies can now securely move from manual, paper-based validation processes to fully electronic validation, enforcing consistency, enhancing compliance, furnishing a holistic view of a company’s validation status, identifying bottlenecks and reducing validation cycle time and cost.
The Traceability Matrix module provides comprehensive traceability needed throughout the entire lifecycle of today’s complex projects from requirements, scope, design and test phases, to ongoing changes, problem and impact analysis. Multiple relationships can be established between requirements, design and testing. Risk is better managed with ValGenesis Traceability Matrix as it identifies critical design elements. ValGenesis is the first system in the industry to provide a real time impact assessment on the affected requirements, scope and design elements from test case failures.
The Validation Planner module proves to auditors exactly how the company brings all systems into a validated status. Validation Planner also provides a single, real-time, accurate view of the organization’s compliance status, which reduces the risk of non-compliance. Validation Planner increases effectiveness and efficiency of validation processes through prioritization and by providing a holistic view of the corporate validation process.
“Our clients and prospects have requested traceability matrix and validation planning functionality to complement the existing ValGenesis’s features. The two new modules make ValGenesis an end to end solution that manages the entire corporate validation process,” said Siva Samy, PhD. Chief Product Strategist of ValGenesis. “Life science companies use ValGenesis to reduce the validation cycle time and cost, enforce consistency across the company and enhance compliance, in addition to minimizing production downtime and maximizing revenue.”
About ValGenesis
The ValGenesis software suite automates and manages the compliance-based validation activities in life science companies. ValGenesis received the Parenteral Drug Association (PDA) New Innovative Technology award in 2005. ValGenesi |
