We’re thrilled to have our IT Project Coordinator, Amy Adams answer a few questions about the new changes in regulatory asset management with Blue Mountain, and how that fits with the larger IT strategy at AmplifyBio.
Please describe your background in Quality systems. What led you to AmplifyBio?
I have previously worked in clinical research where quality systems coincide with patient management systems like Epic. Now that I have transitioned to pre-clinical research, I have expanded my reach to 5 new quality systems, where I am the SME for 3 of them. When I interviewed for AmplifyBio, every person I interviewed with was passionate and driven which confirmed this was the company I wanted to work with. The collaborative work environment, strong team dynamic, and constant learning make every day different and rewarding.
Over 1,000 logbooks have been eliminated since implementation, allowing all data to be in one repository.
What are the key benefits for AmplifyBio with the implementation of Blue Mountain?
Blue Mountain aids our company by eliminating manual touches, reducing errors and cycle time, and mitigates compliance risk. This software has also eliminated paper and 1,000 logbooks within our company, allowing all the data to be in one repository, saving us from having to find the correct logbooks or person of contact. This software also allows us to be audit ready at any time through the querying capabilities. On top of it all, they have fantastic customer service that is ready to help troubleshoot or create new capabilities as needed, so the software can grow as we do! We are planning to grow our use of Blue Mountain to track assets, calibration, and maintenance, as well as user logs, regulatory assets, and facility items that support some of our tracked assets.
What are the key benefits to customers with the implementation of Blue Mountain?
An important customer benefit is that Blue Mountain can be utilized across many different sites, which is beneficial for AmplifyBio as we have one site in West Jefferson, OH, one site in South San Francisco, CA, and a new site soon in New Albany, OH. This allows the capability of ensuring accurate tracking and management of assets, calibration and maintenance from work sites that are across the country, without having to be physically present. It enhances companywide visibilities, which trickles down to the clients we work with, as we can better showcase our capabilities all at the click of a mouse.
How does that fit into a larger IT strategy at AmplifyBio?
This is only one of eight IT projects implemented since the launch of AmplifyBio, with six more projects on the road to completion. From launch, we held as a key priority to add modern, data and workflow driven, paperless business processes that are aligned with our “cloud first” approach. As a company that is focused on cutting edge research and gene therapy, we wanted to ensure that our IT systems are at the forefront of technology to propel the success of advanced therapies.
How will improvements on quality systems complement other study functions at AmplifyBio?
Quality systems at AmplifyBio certify that we are providing the most compliant and accurate data that can be accessed in real time in one large repository. We no longer must search for people or logbooks, request access to enter labs, or wait 30 or more minutes for over 1,000 pages of paper to print out. We, as a company, can now access all data, assets, and information through one portal on our computer. Data is fundamental to what we do and data integrity is key. Minimizing human touches reduces surface area for regulatory and quality errors, mitigates data integrity risks and improves our compliance posture.