A fast-growing preclinical CRO, AmplifyBio is partnering with the SaaS leader in Good Manufacturing Practices (GMP) Solutions, Blue Mountain, to manage the maintenance, calibration, and validation processes of their assets.
STATE COLLEGE, PA — December 1, 2022 —AmplifyBio 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 AmplifyBio.
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 include cell and gene therapies.
“We are honored to be selected as a partner to elevate AmplifyBio’s GxP 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 GxP digital 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).
Blue Mountain is proud to support AmplifyBio’s mission and provide the regulatory expertise needed for advancing medical breakthroughs, treatments, and cures for disease.
Additional Information
For more on Blue Mountain, visit: https://coolblue.com
Connect with Blue Mountain on LinkedIn: https://www.linkedin.com/company/blue-mountain-quality-resources
About Amplify Bio:
AmplifyBio is a leading preclinical CRO (Clinical Research Organization) focused on safety, efficacy, toxicology, and advanced drug characterization to accelerate the development of advanced therapies for patients who need them. 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. To learn more about AmplifyBio, visit https://www.amplify-bio.com/
About Blue Mountain Quality Resources:
Leading the Life Sciences in GMP asset management for 30+ years, Blue Mountain offers deep Life Sciences domain expertise. Founded in 1989, Blue Mountain offers a complete, integrated solution, helping hundreds of Pharmaceutical, Biotech, Cell and Gene Therapy, Medical Device, and Contract Manufacturing companies. Flexible and highly configurable, Blue Mountain Regulatory Asset Manager enables companies of every size and stage to put best practices in place and helps coordinate and automate work. To learn more about Blue Mountain, visit: https://coolblue.com
For more information, contact Akashi Perera at 814-234-2417 or apperera@coolblue.com.