SANTA CLARA, Calif., Dec. 12, 2023 /PRNewswire/ — ValGenesis, Inc., the market leader in enterprise validation lifecycle management solutions, announced that AmplifyBio, a rapidly growing contract research organization (CRO), successfully went live with the ValGenesis validation lifecycle management system (VLMS) to efficiently manage digital validation processes.
AmplifyBio spun out from Battelle, the world’s largest independent nonprofit applied science and technology organization, as a preclinical CRO designing and delivering in vivo safety, efficacy, and toxicology studies for the preparation of investigational new drug (IND) packages. Since their launch, AmplifyBio has steadily expanded services to support the discovery, characterization, optimization, and manufacturing of a broader range of drug modalities and become the industry’s preferred advanced therapy development and commercialization partner.
A vital part of the company’s strategy was to harness cutting-edge technologies to drive efficiencies and set its services apart.
ValGenesis VLMS was a natural choice to support a digital-first model and AmplifyBio went live with the system in late 2023 to digitize their computer systems validation program. The implementation took only eight weeks. In addition to implementing a purpose-built validation system, the team was able to refresh their existing CSV process rather than automate what had become sub-optimal.
Users immediately noticed several process improvements, including reducing the steps and time needed for document approval by 50%, capturing objective evidence in a single step versus tedious copy/pasting, cutting audit findings in half by eliminating documentation errors, collaborating with remote colleagues, standardizing protocols, and reducing subjectivity when assessing risk.
ValGenesis is helping AmplifyBio reduce the administrative time and busy work that comes with validation, enabling them to focus on the work needed to branch out into new therapeutic areas. Users appreciate the efficiency gains, and stakeholders are keen to expand usage into other departments, such as commissioning, qualification and validation (CQV) and facilities/site engineering, as part of the company’s strategy to modernize its technology landscape.
“AmplifyBio is growing rapidly in the pursuit of creating the leading technology-integrated service organization for the commercialization of advanced therapies. A tool like ValGenesis VLMS is invaluable to unlock operational velocity and enhance our agility and efficiency,” said Dev Dutta, Director of Quality IT for AmplifyBio. “By streamlining our CSV program, we create time and cost savings at the same time that we are significantly expanding assay capabilities to meet the evolving scientific and regulatory requirements for the development of next-generation drug modalities.”
“AmplifyBio’s success with ValGenesis VLMS is a validation of our vision to provide unsurpassed enterprise-class digital validation technology in a single system that meets every validation need,” says Dr. Siva Samy, CEO at ValGenesis. “Their adoption of our configurable digital validation platform will not only boost operational efficiency but also solidify their compliance framework, propelling a quick-to-market strategy at all their sites. We eagerly look forward to growing this relationship and helping them quickly implement new capabilities to meet new needs.”
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 https://www.amplify-bio.com/.
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 https://www.valgenesis.com/.
