Your ability to standardize IT solutions throughout your organization drives your level of GMP compliance as well as your profitability.
If you’re looking to improve the performance of your equipment and instrumentation, achieve higher levels of GMP compliance, and reduce your Computer System Validation (CSV) work, you need an effective enterprise asset management system.
Blue Mountain Regulatory Asset Manager is the industry-standard solution. With its 100 percent web-based enterprise software and database architecture, Blue Mountain RAM offers a robust maintenance and calibration feature set that can be installed for a single site with multi-tenancy or configured for individual sites within your organization. Blue Mountain has completed approximately 70 multisite software implementations and offers a full suite of services and enterprise capabilities.
Discover how Blue Mountain RAM can be configured to meet your enterprise needs. With a full suite of services, we can take you from Project Assessment to System Implementation in as little as 3 months.
It doesn’t matter how good your product is if you cannot support it with good knowledgeable people who are willing to go out of their way to work with the clients. Your Blue Mountain engineers have been excellent in responding to our needs and concerns throughout the process, and most importantly as we finalized items for roll-out.
Pharmaceutical Contract Manufacturing Organization
Bonfils Blood Center based in Denver, Colorado is a community leading blood collection center with over 100 healthcare facilities. Founded in the 1940s, Bonfils Blood Center collects approximately 143,000 units of blood every year in order to meet the needs of the local community as well as the military.
As a long time Blue Mountain Quality Resources customer, Bonfils previously used Calibration Manager for the tracking of equipment and asset calibrations. In addition, the company used multiple external applications to track functions such as non-conformance reports (NCRs), asset induction requests and equipment validation.
Goals and Approach
Bonfils’ goal was to eliminate external solutions and consolidate their processes in many departments into a single application. Their desire was to gain a complete picture of their operations. In addition to this, management needed traceability for all assets and an ability to hold technicians to deadlines for work orders. These tools would be used to improve overall customer service standards.
Bonfils wanted to implement a single solution that would eliminate the use of six of their current external applications.
In order to accomplish this, Bonfils chose to upgrade to Blue Mountain RAM Best Practices Template which provides GMP best practices for maintenance and calibration. With Blue Mountain RAM, Bonfils was able to achieve their goal and efficiently manage:
The Solution and Results
Now with Blue Mountain RAM Best Practices Template, Bonfils is able to drive the corporate efficiencies they desire and completely eliminate the use of external applications.
Upgrading to Blue Mountain RAM allowed Bonfils to:
Q&A with Joseph Camera
Joseph Camera is the Equipment Manager at Bonfils Blood Center. Joseph was an active user of Calibration Manager and is now a user of Blue Mountain RAM. He played an integral part in the evaluation and implementation of Blue Mountain RAM.
Why did you choose Blue Mountain RAM as your EAM solution?
“We chose Blue Mountain RAM for two main reasons. First, your software is built from the FDA’s perspective. Other software vendors know about 21 CFR Part 11 but not how it really effects our processes and procedures. The signings and signatures inside of RAM are impressive to me. Your software is very fluidic and really understands our need to be compliant. Second, Blue Mountain RAM focuses on the asset. This wasn’t a hard pitch to me because everything in our company happens at the asset level. Prior to implementing RAM, we were working in so many different applications that it was very challenging to focus on the asset. Now, we are able to easily accomplish this.”
Why did you choose Best Practices Template?
“The Best Practices Template was a great option for Bonfils and is a great option for any company who doesn’t have something currently in place, but wants to leverage industry standards.”
How was the implementation process?
“During the implementation process, the Blue Mountain team was on-point. Project schedules were set by Blue Mountain with complete timelines, what was going on and when training was scheduled. A delay with the software release threatened to push our go live date back, however, Blue Mountain rose to the occasion and was able to meet deadlines that had already been set. The packaged validation protocols were well written and only needed to be reviewed which saved a lot of labor hours. Our overall implementation time was 6 months.”
Was the project within budget?
“The project was right on budget – not over or under budget.”
What ROI have you seen since upgrading to Blue Mountain RAM?
“We have seen returns across the board, especially in areas of monitoring equipment and labor costs. We can isolate equipment that needs to be repaired or view what equipment is breaking frequently. Also, we can now determine projections for when to retire equipment. For labor costs, it is a huge return on investment. Labor hours have become more efficient because our technicians are able to see scheduled events giving them a handle on what’s coming and their next task. We can also determine why a technician was delayed which allow us to improve our processes. All of the little details of the software have resulted as improvements in both our internal and FDA audits.”
Blue Mountain has assisted with the implementation of Blue Mountain RAM at a multi-site biotechnology based organization with an FDA approved product to treat life threatening illnesses. In this instance, Blue Mountain RAM is centrally hosted for multiple facilities & locations throughout the United States. Several thousand assets currently reside within the product’s database and these records serve as a focal point for managing work (maintenance, calibration and validation). Numerous maintenance & calibration technicians along with other personnel depend on access of this application every day. Estimated dependency of regular system users is 15-20 at any one time.
Goals and Approach
A need was identified by this organization to use a validated and Part 11 compliant solution for the purposes of managing work against assets. During early interaction with Blue Mountain, it was discovered that a previous implementation of a competing Computerized Maintenance Management System (CMMS) product was unsuccessful. As an alternative, this organization was evaluating the idea of managing maintenance & calibration management using their existing Enterprise Resource Planning (ERP) system. However, the capabilities fell short upon examination. Blue Mountain RAM was a favored alternative to the pre-existing options due to the purpose built & best-in-class functionality of this software application along with Blue Mountain’s dedication to the life science industry. The initial scope was to include two facilities but has now grown into a four site project.
The Solution and Results
Dependency on Blue Mountain RAM has continued to increase since the time of implementation. The initial project scope included central tracking of organizational assets and management of work schedules and relevant historical data. Since then, there have been initiatives set in motion to be paperless, add additional facilities to the active and validated instance and provide work request access to all employees. This organization has experienced several enhancements to their pre-existing processes. Electronic signatures are in use to better manage review of work in a streamlined fashion. As additional data is collected (i.e. as-found/as-left calibration values, work requests, etc) there are more instantaneous ways to access historical data and run reverse traceability checks, thus increasing compliance. In addition, there has been an ability to harmonize various locations and bring asset management down to one common level amongst sites. Increased efficiency & compliance combined with a better ability to make valid business decisions have provided ROI that will last for years to come.