Santa Clara, December 12, 2023, ValGenesis, Inc.
ValGenesis, Inc., the market leader in enterprise validation lifecycle management solutions, proudly announces the successful deployment of its ValGenesis Validation Lifecycle Management System (VLMS) at AmplifyBio. This landmark implementation marks a significant step forward for AmplifyBio, a rapidly expanding contract research organization (CRO), as it transitions to a fully digital validation process across its operations.
AmplifyBio, which originated from Battelle, the world's largest independent nonprofit applied science and technology organization, has established itself as a preeminent preclinical CRO. Specializing in in vivo safety, efficacy, and toxicology studies, AmplifyBio is critical in preparing investigational new drug (IND) packages. The organization's growth trajectory has been impressive, expanding its service range to support a wide array of drug modalities and becoming an industry frontrunner in advanced therapy development and commercialization.
A cornerstone of AmplifyBio's strategy is the integration of state-of-the-art technologies to enhance efficiency and distinguish its services. The choice of ValGenesis VLMS aligns perfectly with this digital-first approach. The system went live in late 2023, revolutionizing their computer systems validation program. Remarkably, the implementation was completed in a mere eight weeks, showcasing the system's exceptional adaptability and ease of implementation.
The impact of ValGenesis VLMS has been immediately noticeable. Users reported a dramatic 50% reduction in the time and steps required for the validation process. The system's capability to capture objective evidence in a single step, as opposed to the previous tedious copy/paste methods, is a significant advancement. Notably, documentation errors, tracing to the requirements, missing periodic reviews, etc. these common sources of audit findings, were eliminated, enhancing compliance and audit readiness. The platform facilitates seamless collaboration among remote teams, standardizes protocols, and offers a more objective risk assessment.
ValGenesis is more than a solution provider; it's a partner in AmplifyBio's quest to reduce administrative overhead in validation. This partnership enables AmplifyBio to concentrate on expanding into new therapeutic areas. The efficiency gains have been well-received by users and stakeholders, who are now looking to extend the system's application to other departments, including commissioning, qualification, validation (CQV), and facilities/site engineering. This expansion is critical to AmplifyBio's strategy to modernize its technological infrastructure.
"AmplifyBio's success with ValGenesis VLMS is a glowing affirmation of our vision to deliver a premier, all-encompassing digital validation platform," says Dr. Siva Samy, CEO of ValGenesis. "Their embrace of our configurable digital validation platform escalates operational efficiency and fortifies their compliance structure, accelerating market readiness across their locations. We are excited to continue nurturing this relationship and support AmplifyBio in rapidly adapting new capabilities to meet evolving demands."
"ValGenesis is thrilled to witness the transformative effect our VLMS has had on AmplifyBio's processes. Our collaboration stands as a beacon of our dedication to pioneering digital advancements in validation," adds Steve Reynolds, CRO of ValGenesis. "The swift and effective deployment at AmplifyBio exemplifies the adaptability and robustness of our platform. We are proud to back AmplifyBio in their journey towards modernization and efficacy, and anticipate further enhancing their technological prowess through our enduring partnership."
About AmplifyBio
AmplifyBio is a leading contract research organization (CRO) with a breadth of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for advanced therapies. For more information, visit AmplifyBio's website
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 ValGenesis.
Further information:
Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 althea.dsylva@valgenesis.com