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ValGenesis Releases Standalone Cloud-based Electronic Logbook Application Purpose-built for the Regulated Life Sciences Industry

ValGenesis News | Published: April 13, 2022

San Francisco, April 13, 2022: ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), today announced the release of a newly updated version of ValGenesis e-Logbook, a next-generation electronic logbook application purpose-built for the stringent demands of the regulated life sciences industry.  

Cloud-based ValGenesis e-Logbook is Part 11/Annex 11 compliant, built for security-sensitive facilities, and can scale to thousands of users across multiple global sites. From a browser-based app that functions even in offline mode, fully configurable electronic forms capture of observed and non-automated data within the control room and throughout the plant, ValGenesis e-Logbook is ideal for all aspects of manufacturing.  

ValGenesis e-Logbook goes way beyond just data capture. It enables the application of business logic through configurable workflows for review and approval, QR-code scanning for accuracy and efficiency, comprehensive audit trails with real-time access to data, reporting and trends, and automated and validated calculations and reports. All these features keep log activities, reviews and approvals moving 24/7. In addition, the system takes over calculations and reporting, thereby removing the risks of human error and solving a major part of the Pharma 4.0 journey.

ValGenesis e-Logbook is 100% digital, 100% of the time. Built for secure facilities, it can manage and track data with an easy-to-use mobile app that works even in offline mode.  The zero-paper solution enforces consistency and data integrity in logbook processes by removing the risks of illegible entries, lost logbooks, and incorrect forms. With fully accessible, searchable digital archives, ValGenesis e-Logbook keeps companies inspection-ready.  

ValGenesis offers a library of ready-to-use forms. ValGenesis e-Logbook offers a Log Form Library of 100 common forms. Customers can use a form from this library as-is or customize the fields to match their data and process. This streamlines deployment and further enforces standardization.

"ValGenesis is very sensitive to the evolving needs of the life sciences industry,” says Dr. Siva Samy, CEO & Chief Product Strategist at ValGenesis. “It is this sensitivity that spurred our many innovations in validation lifecycle management. We are excited to present an enhanced, comprehensive digital logbook solution that supports the vision of a 100% paperless manufacturing facility. Committed to continual improvement, we evolve solutions in line with customer needs and ever-changing regulatory requirements,” he stated. 

“Many companies still rely on paper logbooks to satisfy the FDA’s minimum requirements for logbook management. This approach is beset with disadvantages, including a high probability of human error and an increased threat of 483s and warning letters,” says Narayan Raj, Chief Operating Officer at ValGenesis. “ValGenesis e-Logbook helps companies overcome these challenges, enforcing standardization, and enabling functioning even in offline mode. We strongly believe our clients will benefit from this enhanced feature-rich e-logbook solution," he stated. 

 

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that serves as 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

Further information:

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 althea.dsylva@valgenesis.com

Summary

Cloud-based ValGenesis e-Logbook is Part 11/Annex 11 compliant, built for security-sensitive facilities, and can scale to thousands of users across multiple global sites.

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