SAN FRANCISCO, May 3, 2022 /PRNewswire/ — ValGenesis, Inc., the market leader in enterprise Validation Lifecycle Management Systems (VLMS), today announced that ValGenesis e-Logbook was validated and went live as the corporate electronic logbook at one of the world’s top 5 life sciences companies.
ValGenesis e-Logbook is a next-generation electronic logbook application purpose-built for the stringent demands of the regulated life sciences industry. The software transforms paper-based logbook processes into a dynamic digital GxP data capture system through designed data forms that can handle processes such as cleaning, equipment tracking, usage, calibration, and monitoring. User requirements across teams are efficiently captured in the new system, which triggers them to action, helping prevent discrepancies and enforce compliance.
The customer further states that the automated scheduler feature in ValGenesis e-Logbook is maintaining its systems (clean rooms), assets (equipment usage, tracking mobile equipment, calibration) and processes (clean hold time, dirty hold time) in compliant status by triggering the respective data capture events on time. Configurable workflows and enterprise system process harmonization is enforcing standard operating procedures (SOP) in relation to recording, verifying, and reviewing data capture logs. Other features the customer extols include quick access to logs and data and the easy creation of logbooks; a hierarchical structure to monitor and capture all components of an asset; verification and review of all log entries through controlled workflows; and the ability to decrease/eliminate the risk of using incorrect or out of service equipment. According to the customer, these features "provide the assurance of ‘correct first-time data capture’ that is dramatically decreasing process errors and improving regulatory compliance."
Cloud-based ValGenesis e-Logbook is Part 11/Annex 11 compliant, built for security-sensitive facilities with restricted network access, and scalable to thousands of users across multiple global sites to enforce consistency and data integrity in all logbook processes.
"We are excited that more companies are experiencing dramatic transformation through ValGenesis e-Logbook," says Narayan Raj, Chief Operating Officer at ValGenesis. "We are committed to evolving solutions in line with our customers’ pressing needs, and this is ground proof of that commitment. It is never easy to keep up with ever-changing regulatory requirements but feature-rich solutions like ValGenesis e-Logbook make it so," he stated.
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
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex. 1026,
SOURCE ValGenesis Inc.