SANTA CLARA, Calif.: ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that a major healthcare provider in the U.S., delivering high-quality services through a complex network of medical institutions, has chosen ValGenesis VLMS to simplify validation complexity and achieve seamless FDA compliance.

The institution’s existing validation activities rely on a combination of disparate applications and manual procedures, resulting in fragmented information stored across locations and formats. This fragmented approach complicates audits and overall regulatory compliance. ValGenesis VLMS was chosen to streamline the entire FDA computer system validation (CSV) lifecycle and provide robust role-based security to ensure data integrity and full 21 CFR Part 11 compliance.

Furthermore, the VLMS will govern both regulated and nonregulated systems, enabling seamless deviation tracking, and provide electronic execution and approval, ensuring full traceability to all testing and configurations. ValGenesis VLMS eliminates the need for time-intensive protocol re-creation, potentially saving the institution hundreds of hours per month. By leveraging decision trees, the system can automatically create protocols simply by answering predefined questions aligned with the institution’s SOPs, ensuring both consistency and efficiency in authoring. Dynamic data visualizations will ensure clarity into validation activities across the enterprise, and enhanced analytics tools will provide valuable insights that will enable the institution to make objective, data-driven decisions.

"As healthcare regulations evolve, ValGenesis VLMS empowers such institutions to adapt seamlessly. Our platform natively supports critical features like risk-based testing and provides intelligent insights across validation activities to unlock unprecedented operational efficiency. We are thrilled to be able to digitally transform this renowned institution and advance its vital healthcare services across the US," said Steve Reynolds, ValGenesis’ chief revenue officer.

ABOUT VALGENESIS

ValGenesis Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and EU Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. For more information, visit www.valgenesis.com.

Fonte: Business Wire