SAN FRANCISCO, June 18, 2019 /PRNewswire/
ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), today announced the release of its next generation Electronic Logbook (eLog). The ValGenesis eLog extends plant floor automation by managing and tracking equipment use, cleaning status, maintenance and calibration records with an easy to use mobile App with support for commonly used tablets such as iPad and Android devices. Users can capture the logs through mobile devices by simply scanning the QR code available at the equipment, instruments and clean rooms, with or without network connectivity. This helps end users to easily schedule, assign, track and report all equipment information needed to meet corporate compliance requirements, as well as forms a strong foundation for asset management strategy along with validation status.
Analysts and technicians can access equipment cleaning batch records and execute procedures with complete, real-time data capture at each step of the cleaning procedure, thus providing 360-degree visibility for any piece of equipment throughout its lifecycle.
The ValGenesis eLog manages all types of logs, including equipment usage/cleaning, calibration, maintenance and other system logs like backups. It also delivers the equipment-related information needed to generate an electronic cleaning batch record and supports the vision of a paperless manufacturing facility. ValGenesis eLog is fully compliant with regulatory requirements, including 21 CFR Part 11 and data integrity requirements such as PIC/S.
At the operational level, ValGenesis eLog offers a number of immediate benefits for regulated companies that are manually managing logbooks:
- Eliminates paper-based logbooks and binders
- Log entries can be verified and reviewed through controlled workflows
- Facilitates compliance with FDA 21 CFR 211.182
- Clean and dirty hold times can be defined as per approved procedures
- Scheduled system alerts and reminders for upcoming due dates for tasks
- Decreased risk of using incorrect or out of service equipment
- Complete equipment usage traceability
- Ensures data integrity with all data captured “direct to database” (required for compliant operation)
- Removes risk of human error in equipment usage and cleaning log management operations with automated, validated calculations and reports.
“ValGenesis has been a trailblazer in electronic Validation Lifecycle Management software for the life science industry. The release of ValGenesis eLog further establishes our leadership in the industry and our ability to execute as we bring additional gains to the significant efficiency improvements the system already provides over the traditional paper-based approach,” says Narayan Raj, Sr. Vice President of ValGenesis, Inc.
“ValGenesis VLMS 4.0 has been well received by all our current clients. We strongly believe our clients will benefit from this new eLog solution,” stated Robert van der Laan, Vice President of Professional Services at ValGenesis, Inc.
“ValGenesis has been a trusted name in paperless validation for years by many top global life science companies. Over forty of our clients requested a solution to manage equipment and clean room logs as part of our VLMS platform, so that they could have a holistic view of GxP assets across the organization. ValGenesis is committed to continual improvement, and as part of this commitment, it continues to evolve its offerings in line with the needs of our customers and ever-changing regulatory requirements, technology landscape and business environments,” said Dr. Siva Samy, CEO & Chief Product Strategist of ValGenesis, Inc.