SAN FRANCISCO, Sept. 8, 2020 /PRNewswire/ — ValGenesis, Inc., a market leader in paperless validation solutions, today announced that its Validation Lifecycle Management System (VLMS) supports Augmented Reality (AR) for remote and hands-free validation, to improve efficiency, data integrity, and compliance in the corporate validation process.
During validation and qualification in cleanrooms and aseptic manufacturing facilities, engineers can instantly access and view work instructions, schematics, and protocol test steps with a simple voice command to the wearable AR device. All protocol details can be captured simply by dictating results and objective evidence such as photos and videos with intuitive voice commands. Captured results with objective evidence will be securely recorded in real-time. This complete hands-free validation process is fully compliant with FDA 21 CFR Part 11 and Annex 11 requirements. With the technological advancements of AR extending into validation, all these processes become simplified and interactive, particularly in cleanrooms and aseptic manufacturing facilities.
At the operational level, AR improves the efficiency of validation execution, enables data integrity governance, and reduces human error. Here are a few of the many functions offered by the AR application in ValGenesis VLMS:
Complete hands-free validation: Validation execution activities can be remotely monitored in cleanrooms and aseptic manufacturing facilities. The person operating the wearable, hands-free device does not require a laptop, tablet or even paper to document validation execution results because the hands-free device automatically captures and records all the required information via the AR device.
Remote expert support through Microsoft® Teams: On-demand remote assistance functionality allows validation Subject Matter Experts (SMEs) to quickly pull in a colleague or supervisor when their expertise is required. This includes on-demand video calls, real-time chats, and even the ability to share images that can include annotated markups from the expert.
Guided complex validation processes: Uses electronic work instructions and digital overlays to help guide validation SMEs through complex validation procedures, thereby ensuring compliance with regulatory requirements and enabling standardization.
“ValGenesis VLMS has been trusted by several global life science companies for paperless validation and is the system of record for their corporate validation processes. ValGenesis is committed to continual improvement, and as part of this commitment, continues to evolve its offerings in line with the evolving needs of its customers and the ever-changing regulatory requirements, technology landscapes, and business environments. In collaboration with our current clients, ValGenesis continues to build its leadership position for its Validation Lifecycle Management System, which is being recognized as the de-facto standard for supporting a paperless validation lifecycle process. ValGenesis now offers an innovative AR solution to help clients improve the efficiency of the validation process while ensuring compliance and data integrity,” says Dr. Siva Samy, CEO and Chief Product Strategist at ValGenesis Inc.
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, [email protected]
SOURCE ValGenesis Inc.