An early adopter of this technology, the company now seeks to expand use of ValGenesis’s system across multiple sites and countries to standardize and harmonize the validation process across the organization.
SAN FRANCISCO, Nov. 27, 2018 /PRNewswire/
ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management Solutions (VLMS), today announced that a Global Life Sciences Company will be expanding its use of ValGenesis’s 100% paperless Validation Lifecycle Management System across over fifty global manufacturing sites to manage its corporate validation lifecycle process. At present, ValGenesis VLMS is live at five of the company’s major sites across the U.S. and Europe and will be rolled out at five more sites across four countries, with multilingual support, by the end of 2018.
A couple of years ago, the company’s Quality Validation unit had set out to examine and improve validation activities at two of its sites – the overarching goal being to create leaner, more efficient processes in the validation organization. Historically, validation activities at these sites had been performed utilizing a time-consuming paper-based system. Recognizing that traditional, manual, paper-based validation processes were proving costly and inefficient, the company rolled out ValGenesis VLMS, a fully compliant electronic-based system, with an implementation period of only three months. This has helped the company significantly reduce validation cycle time, gain a higher standard of data integrity, improve its regulatory compliance process, and gain a holistic view of real-time validation status across its regulated systems, thereby improving the quality and speed of the entire process.
Near the end of 2018, ValGenesis released VLMS 4.0, the latest version of its 100% paperless Validation Lifecycle Management System, which is being increasingly recognized as the de facto standard for supporting a Paperless Validation Lifecycle process. The system’s new, more intuitive interface has been well received by early adopters and several implementations are already underway, with ValGenesis’ first set of customers expected to go live in Q1 2019.
This company is one among many that have been impressed with VLMS 4.0’s exciting new features, which include multilingual support, a service that no other validation management solution currently on the market is able to provide. ValGenesis makes it a priority to work actively with clients, incorporating their feedback and using it to continually enhance user experience, real-time collaboration, data integrity, risk assessment and compliance adherence processes. VLMS 4.0 is the culmination of this continued systemic collaboration.
“Traditional validation activities with paper-based validation processes stifle innovation, cause compliance risks and compromise life science firms’ ability to bring products to market on time. ValGenesis helps all regulated manufacturing companies to manage the validation process electronically, reduce validation cycle time, and enforce consistency and compliance in the corporate validation process,” says Siva Samy, ValGenesis CEO & Chief Product Strategist. “The scalable and configurable nature of ValGenesis helps global companies implement at a single site or department level, as well as to expand globally. Our product allows corporate quality leaders to monitor the validation status of any instrument, equipment, software system or process remotely and in real time for any site. In addition, it enables multi-site companies to reuse validation data and protocols globally across all sites, reducing validation cost and cycle time while improving consistency. We look forward to working as a strategic partner and providing a robust framework to meet our global client’s validation lifecycle management needs.”
Althea D’Sylva, ValGenesis Communications, +1 510 445 0505 Ex. 1026,
ValGenesis, Inc. is the creator of an innovative software platform that serves as the 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. As the first fully paperless solution for managing validation execution and approval 100% electronically, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. The solution is also fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements.
For more information, visit https://www.valgenesis.com