Regardless of facility size, productivity is typically driven by efficient documentation, automation and high levels of Overall Equipment Effectiveness (OEE).
There are more than 100 CMMSs that can manage maintenance and GMP equipment, but only Blue Mountain RAM was designed specifically for Life Sciences. Our system streamlines your maintenance documentation functions by combining traditional CMMS elements—equipment inventory, work management, purchasing, labor, spare parts—with robust workflow automation and electronic signatures. Implemented for hundreds of GMP users, Blue Mountain RAM configures to your best practices and supports your Maintenance Excellence programs. It gives you:
Discover how Blue Mountain RAM can be configured to meet your unique maintenance (and calibration) needs. With a full suite of services, we can take you from Project Assessment to System Implementation in as little as 3 months.
We have set aggressive goals for Facilities and manufacturing equipment management, including the implementation of a more proactive Total Productive Maintenance (TPM) approach, Blue Mountain Regulatory Asset Manager will enable us to meet our goals, harmonize all activity around equipment management in a single application and streamline processes while satisfying regulatory requirements.
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:
This newly developed single-site laboratory focuses on scientific discoveries in regenerative medicine. This organization understood the importance of managing their critical & non-critical assets in a way that reflected their overall attitude towards operational cleanliness, compliance and facility management. An opportunity to begin managing assets without relying on paper and spreadsheets was a driving factor in the decision to purchase Blue Mountain RAM. The idea of putting a validated and paperless Part 11 compliant software application to use was well received by management and end users alike.
Goal and Approach
Most important to this customer was a solution that could be implemented with minimal effort but still grow and expand over time. The customer was able to capitalize on a pre-built configuration that also allowed a large number of template reports to work with/without alteration. These reports provide indicators and metrics relevant to the work performed, actively being performed and already performed.
Blue Mountain assisted with the implementation and the software is installed, configured and validated on local servers. This customer’s instance requires little to no daily system maintenance aside from adding/removing users, modifying queries, etc. At the moment, a few hundred assets reside within their database. A few users access the application on a regular basis.
The Solution and Results
Since implementation, the number of assets has grown significantly. The single concurrent user license was recently increased to five users. Because of Blue Mountain RAM, this customer has been able to begin laboratory operations with a best-in-class asset management solution designed specifically for the Life Science industry. Their ability to manage relationships between equipment, work to be performed, ad-hoc work and export data to make valuable business decisions ensures their return on investment has already begun.
Compliance is also a non-issue. Blue Mountain RAM allows users to query data and open appropriate records on demand, which is extremely helpful in audit situations.