A fast-growing, preclinical CRO, AmplifyBio is partnering with the SaaS leader in Good Manufacturing Practice (GMP) Solutions, Blue Mountain, to manage the maintenance, calibration and validation processes of their assets.
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WEST JEFFERSON, Ohio, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Amplify Bio has selected Blue Mountain Regulatory Asset Manager (RAM) to help with incorporating industry best practices and ensuring electronic records compliance.
"Blue Mountain RAM will enable us to meet our compliance goals, harmonize all activity around GxP asset management in a single system and streamline processes while ensuring regulatory requirements," said, Dev Dutta, Director of Quality IT at Amplify Bio.
AmplifyBio is utilizing Blue Mountain RAM to harmonize regulatory asset management and streamline calibration and maintenance activities, switching from a paper-based system to an electronic system that will enable them to meet 21 CFR Part 11 compliance requirements, and mitigate quality and data integrity risks. Since their go live, AmplifyBio has eliminated paper logbooks for over 1,700 pieces of equipment and over 1,000 maintenance, and calibration schedules will no longer require manual tracking. The AmplifyBio team will rely on Blue Mountain RAM to effectively manage GxP standards for preclinical services applied to various study endpoints and a wide range of drug types that includes cell and gene therapies.
"We are honored to be selected as a partner to elevate Amplify Bio's GMP program by providing a clear path towards digital maturity," said the CEO of Blue Mountain, David Rode. "Our focus on Life Sciences for the past 30 years has provided invaluable insights into an ever-changing regulatory environment and how to make steady progress towards achieving the highest level of GMP maturity."
In one seamlessly integrated system, Blue Mountain RAM provides world-class calibration and maintenance management, all while ensuring GxP compliance. Designed for the Life Sciences industry, the system features built-in best practices and combines the capabilities of an Enterprise Asset Manager (EAM), a Computerized Maintenance Management System (CMMS), and a Computerized Calibration Management System (CCMS).
AmplifyBio's is proud to partner with Blue Mountain and be able to provide the regulatory compliance and quality assurance drug development clients require to advance medical breakthroughs, treatments, and cures for disease.
For more on AmplifyBio, visit: www.amplify-bio.com
Connect with AmplifyBio on LinkedIn: https://www.linkedin.com/company/71550758
About Blue Mountain
Leading the Life Sciences in GMP asset management for 30+ years, Blue Mountain offers deep Life Sciences domain expertise & SaaS solutions to help companies transform their manufacturing processes and achieve the highest level of GMP digital maturity. Blue Mountain offers a complete, integrated solution, helping hundreds of Pharmaceutical, Biotech, Cell and Gene Therapy, Medical Device, and Contract Manufacturing companies fast-track the implementation of GMP SaaS solutions across their organizations. For more on Blue Mountain, visit: https://coolblue.com
AmplifyBio is a leading preclinical CRO focused on toxicology, safety, and pharmacology testing to advance therapeutics for the betterment of human health. Spun out of Battelle in May of 2021, AmplifyBio's mission is to continue to provide exceptional CRO study services in an agile environment better suited to commercial goals and expand analytic capabilities to serve the dynamic needs of advanced therapy development. Clients of AmplifyBio enjoy the peace of mind that comes from decades of experience in GLP and non-GLP study design and execution, combined with rapid investment in technology, expertise, and infrastructure that together provide the critical components of a reliable, agile partnership. www.amplify-bio.com
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