ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a rapidly expanding contract development and manufacturing organization (CDMO), serving a global market, selected ValGenesis e-Logbook to digitize logbook management across its manufacturing sites.
The company uses advanced nitrogen purging capabilities and is a state-of-the-art fill/finish CDMO specializing in sterile filling of vials, syringes, and cartridges for the biotech and pharmaceutical industries. While swiftly expanding its capabilities through state-of-the-art robotic manufacturing lines, the company had invested in new and sophisticated equipment, including autoclaves, water injection systems, scanners and analyzers, cleanroom microplate readers, testing equipment and more. They chose ValGenesis e-Logbook for its ability to digitize the entire process, incorporating business rules to enforce operating procedures to optimize productivity, ensure compliance, and mitigate risk.
ValGenesis e-Logbook is a next-generation electronic logbook application, purpose-built for the stringent demands of the regulated life sciences industry. Part 11 and Annex 11 compliant, it can scale to thousands of users across multiple global sites, even working offline for strictly controlled and secured facilities. The depth and breadth of functionality within ValGenesis e-Logbook was seen as a “game changer” by the company.
“Transitioning from paper to electronic logbooks is becoming imperative for organizations seeking to streamline operations and maintain compliance,” says Steve Reynolds, Chief Revenue Officer at ValGenesis. “Central to the effectiveness of any electronic logbook software application is the integration of robust business rules to establish clear expectations and ensure consistent outcomes. This is possible with ValGenesis e-Logbook, as our customer is now aware. We are excited about our journey ahead with this rapidly evolving innovator.”
About ValGenesis
ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life science 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 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
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Contacts
Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026 althea.dsylva@valgenesis.com
