Flexible and highly configurable, Blue Mountain’s Regulatory Asset Manager (RAM) was designed for Biotech. It enables companies of every size and stage to put Best Practices in place and helps you coordinate and automate your work at a price point even early stage start-ups can handle. Because the system is highly configurable, it allows for an easy transition from the simpler needs of R&D to the more complex requirements of full-scale, multi-site production.
Blue Mountain Quality Resources:
As a Biotech manufacturer, you can implement Blue Mountain RAM using either our Best Practices Template or a Custom Configuration. With a full suite of services, we can take you from Project Assessment to System Implementation in as little as 3 months.
Blue Mountain Regulatory Asset Manager provides a surprising amount of value for its cost, with Blue Mountain Regulatory Asset Manager we’ll be able to improve processes for scheduling and planning, and operate more effectively by replacing legacy systems that weren’t designed for our future needs.
Director of Engineering,
Founded in 1989, Vericel Corporation (formerly Aastrom Biosciences, Inc.) is a leader in the biotech industry. Focused on the development of cellular therapies, one of the company’s products, ixmyelocel-T, treats severe cardiovascular disease using an autologous process that starts with the patient’s own bone marrow.
In their 5,000 sq. ft. facility in Ann Arbor, Michigan, Vericel leverages Blue Mountain RAM to manage the calibration and maintenance of their equipment. Prior to implementing Blue Mountain RAM, Vericel used Blue Mountain’s legacy product Calibration Manager.
Goals and Approach
Vericel’s Michigan facility discovered a need to upgrade Calibration Manager to Blue Mountain RAM and consolidate their maintenance and calibration systems. The company looked to achieve three main goals during the upgrade process:
The Solution and Results
Blue Mountain worked with Vericel to successfully implement Blue Mountain RAM in as little as 3 months from project kickoff to go live. As a result of utilizing Blue Mountain RAM as both a maintenance and calibration program, Vericel gained several significant benefits including:
Dendreon Corporation, based in Seattle, WA, is a leading-edge biotechnology company focused on developing, commercializing and manufacturing cancer treatment therapeutics. As a long standing Blue Mountain Quality Resources customer, Dendreon used our previous product Calibration Manager and upgraded to our newest product Blue Mountain RAM in order to integrate their equipment maintenance and calibration.
With two separate implementations of Blue Mountain RAM, Dendreon manages equipment for both GMP and non-GMP environments. Each implementation is used to harmonize maintenance and calibration management, as well as, inventory and procurement management within the facility.
Dendreon maintains a host of equipment types including water for injection systems, pure water systems, reverse osmosis systems, clean steam generators, high pressure boilers, HVAC systems and compressed air vacuum systems. In addition, their calibration department uses equipment such as balances, centrifuges, freezers, incubators and autoclaves.
Dendreon was dependent upon a paper-based environment for work execution, technicians print work plans, jobs and job steps to carry into workspaces. Once the work was performed, technicians documented data on paper and return to their desktops to enter it into Blue Mountain RAM. The paper-based approach was used primarily to avoid damaging laptops and due to a lack of wireless network access in the facility.
Goals and Approach
The goal was to go paperless by incorporating the Apple iPad® into the daily operations of their technicians. This would cut out unnecessary steps such as copying data from a paper record and prevent data entry errors. Dendreon successfully went mobile by:
The Solution and Results
Dendreon successfully implemented mobile devices using Blue Mountain RAM. The use of Apple iPads created a completely paperless environment for Dendreon which cut both the time spent completing maintenance and calibration work as well as increased efficiency of planning and scheduling.
Going mobile allowed Dendreon to:
Hear Dendreon’s success story in our short video.