Customers

Since 1989, Blue Mountain Quality Resources has set the industry standard for regulatory asset management software and services for the Life Sciences industry

We’ve worked with well over 1000 customers over the years ranging from niche firms to mid-sized companies to the Fortune 500. Today, we focus exclusively on four segments of the industry:

  • Biotech: Companies like Roche, Dendreon and Regeneron.
  • Medical Device: Manufacturers like Boston Scientific, B Braun and Edwards Life Sciences.
  • Pharmaceutical: Firms like Allergan, Novartis, and Alexza. 
  • Contract Manufacturers: CMOs like Noven Pharmaceuticals, Jubilant HollisterStier and Althea Technologies.

Success Stories

Bonfils Blood Center

Customer Profile

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:

  • Maintenance and Calibration
  • Non-Conformance Reports
  • Equipment Validation
  • Change Control Management
  • Asset Induction Requests

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:

  • Review quarterly goals in order to drive corporate efficiencies
  • Eliminate external systems
  • Enhance scheduling which drastically reduced missed work orders
  • Improve technician response via faster calibration and maintenance turnaround times
  • Enhance compliance with streamlined processes and procedures
  • Gain enhanced asset traceability for auditors

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.”

Dendreon Corporation

Customer Profile

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:

  • Integrating wireless network access throughout the facility including all workspaces, basements, areas of facility roof, mechanical spaces and labs to meet 100% WiFi coverage in the facility.
  • Acquiring Apple iPads for technicians – The sales force at Dendreon was already using Apple iPads and the facilities department was able to follow suit now with adequate wireless and necessary corporate acceptance.
  • Upgrading to the latest version of Blue Mountain RAM which provides mobile device support.

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:

  • Improve speed of work execution
  • Increase accuracy of technicians data entry
  • Improve instrument availability via faster calibration and maintenance turnaround times
  • Enhance compliance with streamlined processes and procedures
  • Improve critical decision making through quick, mobile access to business information

 

Hear Dendreon’s success story in our short video.

Vericel

Customer Profile

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:

  • Implement Blue Mountain RAM and provide user training on a fast track
  • Streamline current business processes and standard operating procedures
  • Evaluate and utilize new functionality available in Blue Mountain RAM

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:

  • Overall Improved Productivity – By utilizing functionality inherent in Blue Mountain RAM such as user workspaces, Vericel was able to increase technician productivity.
  • Improved Processes – During the implementation, Vericel assessed their current business processes and standard operating procedures and altered them in order to streamline work.
  • On-Going Increases in Return on Investment – Vericel plans to utilize additional functionality of Blue Mountain RAM over time which will increase their ROI and continue to improve productivity. In the future, Vericel looks to rollout additional work order features such as spare parts tracking and work requests.

Small Biotech Firm

Customer Profile 

A small North American biotech company, with two manufacturing facilities, with approximately 5000 instruments and manufacturing equipment to manage, and five technicians were using multiple applications to manage calibration and maintenance work within their facility.  

To mitigate findings by a regulatory agency, this company had a number of areas that needed attention, including: 

  • Strengthen their internal Maintenance Management Program in a comprehensive fashion
  • Introduce a spare parts management program
  • Effectively coordinate, manage and integrate their calibration program with the maintenance management program
  • Improve their compliance position
  • Implement and utilize the solution on a very fast track

Given this was not a budgeted project, a cost effective solution was also important to them. The fast track they were on meant the implementation process be basic, meet compliance requirements and be short in duration.

Goals and Approach

To satisfy these issues, the customer selected the preconfigured, out-of-the-box version of Blue Mountain RAM. It requires minimal implementation services, some of which are provided remotely.  This significantly reduced the implementation process, which in turn reduced the cost of the project.

The customer considered doing some of the implementation work themselves in an attempt to further reduce the cost.  However, given the effort required, lack of available internal resources, and the time it would take, the customer reconsidered and engaged Blue Mountain’s software implementation analysts to complete the work primarily in the interest of a fast, compliant, expertly performed implementation.

The Solution and Results 

Improvements were made to streamline their business process resulting in early productivity improvements.  The maintenance management portion of the project was of primary importance and implemented first.  The software has enabled them to put into place a much needed and improved spare parts management program, further reducing their costs while enhancing management oversight.  The customer was extremely pleased with the expertise provided during the implementation.  This allowed them to keep the project moving at a fast pace, while also being provided needed guidance.

Multi-site Biotech Manufacturer

Customer Profile

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.

Medical Device Manufacturer

Customer Profile

A global leader in medical device manufacturing with over 5,000 employees, five manufacturing sites and upward of 50,000 assets globally needed to harmonize its calibration and maintenance management programs.   This company manages work and scheduling for over 100,000 calibration and maintenance events annually with the majority of the work being performed in-house using internal technicians. The individual sites vary in size, amount of assets and resources to support those assets and associated service events. They have more than 35 calibration and GMP maintenance team members.

Goals and Approach

Prior to implementing Blue Mountain RAM, the company was using a variety of software applications at the different sites to manage its maintenance and metrology programs. All of the systems were paper-based and inefficient. Each site had independent programs, processes and practices, which were inconsistent between sites.

Blue Mountain Quality Resources was contacted by their corporate site management and asked to provide a Enterprise Asset Management (EAM) solution that would harmonize all of the sites management, scheduling and performance of the assets service events.  Blue Mountain Quality Resources took on the project to improve the customer’s corporate Metrology and Maintenance program compliance. 

The Solution and Results

Blue Mountain Quality Resources worked with the customer to successfully implement the application allowing the company to use the validated software application globally. Blue Mountain Quality Resources partnered with the users to identify their user requirements, process needs and configuration requirements to achieve global standardization and compliance.

The implementation of Blue Mountain RAM has achieved:

  • Streamlined work flows resulting in productivity gains
  • Reduced equipment and instrument downtime
  • Increased organizational efficiency
  • Harmonized procedures and practices
  • Improved accountability of assets
  • Improved GMP compliance
  • Increased asset owner participation
  • Improved communications and collaboration
  • Reduce IT costs by consolidation and standardization

Blue Mountain Quality Resources continues to work with this customer to identify new requirements and works to meet those needs as this medical device continues to expand globally.

Global Medical Device Firm

Customer Profile

This flagship facility of a top-tier global medical device manufacturer was managing calibration work and schedules for 50,000+ instruments.  As a result, hundreds of thousands of calibrations a year are performed by a staff of 15 calibration technicians doing most of the work in house. They are also considered the leader in metrology best practices within their organization’s many global facilities.

Goals and Approach

The client had a compliance risk with their legacy Computerized Calibration Management System (CCMS) and the corporate solution for maintenance did not have the calibration tracking and management capabilities they were seeking.  The client identified key requirements around FDA compliance, metrology data tracking and IT architecture.  

The new system had to have a computer system validation methodology associated with it that had been proven in the real world.  It also had to include 21 CFR Part 11 compliant Electronic Signature that will allow them to increase efficiencies by implementing a paperless system for their entire metrology department.  

The solution had to include tools to evaluate measurement data for trending and to identify Out Of Tolerance (OOT) events.  Ideally the system could be configured to send notifications out to users and instrument owners for key events such as OOT and instruments that were past their calibration due dates.

The Solution and Results

Blue Mountain RAM was selected and has exceeded the customer’s expectations on all of their requirements in addition to several areas outside those original requirements.  By partnering with Blue Mountain the client was able to leverage Blue Mountain’s in-house expertise for configuration and computer system validation and have the system expertly validated following the GAMP guidelines in a very timely and efficient manner.

Utilizing Blue Mountain RAM’s configurable business rules, in combination with 21 CFR Part 11 Electronic Signature functionality, allowed the client to implement a paperless system for their daily operations.  The Electronic Signature and configurable Business Rule Record Routing also allowed the company to take advantage of Blue Mountain RAM’s free unlimited Requestor Licenses to eliminate the need for an external request system.  Utilizing the software’s request system increased compliance by giving them full traceability from the discovery of an issue on GMP critical equipment through resolution within a validated system.  Efficiency gains were realized throughout their business process by having Blue Mountain create and implement several Key Performance Indicator Reports.  Blue Mountain RAM’s integrated reports were also used to create custom instrument labels, thus eliminating the hand-written ones they had been using.  

Blue Mountain RAM’s architecture gave the client confidence in the long-term stability and viability of the application.  The client is making plans for facilities around the globe to access their own data with this instance of the application, allowing the company to exponentially increase their ROI by leveraging their investment in Blue Mountain RAM across their enterprise.

Pharma Research Organization

Customer Profile

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.

Goals 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.

Pharmaceuticals Company

Customer Profile

A multi-billion dollar business unit of a global pharmaceutical company with more than 10,000 assets and 10+ calibration technicians, administrators, supervisors and managers wanted to create a new in-house paperless metrology program. After evaluating software options, they selected Blue Mountain RAM.  In addition to best-in-class calibration functionality, it was important the vendor have experience integrating their solution with SAP PM in a validated environment.

Goals and Approach

The goal was to implement a new in-house metrology program to address business changes, provide tighter control over their internal calibration processes and compliance, and better manage their costs.  Future plans include providing metrology services for other facilities within the company and/or provide a validated Computerized Calibration Management System (CCMS) platform for other facilities to share.

The Solution and Results

The company has successfully implemented a paperless calibration management program using Blue Mountain RAM.  The software has allowed them to accomplish their pre-implementation goals and objectives:

  • Improved management/accuracy of asset information
  • Improved instrument availability via faster calibration turnaround times
  • Better planning and scheduling for the department and the instrument owners has improved operations and productivity
  • Better processes and procedures have enhanced compliance
  • Quick access to business information has improved critical decision making. 

Contract Calibration Company

Customer Profile

PCI, a nationally recognized contract calibration service company with more than 10,000 assets and over 75 engineers and technicians on staff wanted to transition to a paperless environment that would be scalable to future satellite service centers as the company grows. In addition to calibration services this firm also offers other solutions including maintenance program administration service for FDA regulated companies. After evaluating several software options, including Maximo, SAP PM, and Datastream products, Blue Mountain’s Regulatory Asset Manager software was chosen

Goals and Approach

The goal was to implement a new in-house maintenance & calibration program to address business changes, provide tighter control over their internal calibration and inspection processes and compliance, and better manage their costs. Future plans include providing interfacing the software with the accounting system.

The Solution and Results

The company has successfully implemented a paperless calibration management program using Blue Mountain RAM. The software has allowed them to accomplish their pre-implementation goals and objectives:

  • Improved management of asset information via paperless change control processes
  • Improved instrument availability via faster calibration turnaround times; for both internal test equipment and for customer instruments
  • Better planning and scheduling for the department and the instrument owners has improved operations and productivity
  • Quick access to business information has improved critical decision making
  • Automated metrics or key performance indicators (KPIs)
  • Full integration with the exiting web-base accounting system (Sage’s MAS500 software) which allowed for customer invoicing upon work order completion