Biotech

Your ultimate goal is to introduce a new, safe, effective therapy to market. Getting there involves sophisticated processes and products that must meet the highest of standards.

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:

  • Offers deep Biotech domain expertise
  • Develops functionalities specific to the biotech industry
  • Offers specific solutions for small, medium and large-sized firms

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.

Why Blue Mountain RAM?

Manage Lab, Analytical and Process Instruments

Leverage best-in-class functionality that is specific to your needs and equipment including enhanced electronic logbooks, process measurement data templates and custom non-conformance workflows.

Scale with Growth

Use Blue Mountain RAM during clinical trials and easily expand when you reach full production – driving standardized and compliant processes. Great for both startups and large scale Biotech companies.

Comply with Part 11, Part 58, Part 211 and Part 606

Gain the necessary technical controls to enable Part 11 compliance. Designed to be used in compliance with ISO 9000 and the FDA’s GMP & QSR regulations.

Biotech Customers

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.

Stacy Sutton
Director of Engineering,
Althea Technologies

Success Stories

 

Vericel Corporation

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.

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.

Everything You Need to Know About Biotech

Discover how RAM can be configured to meet your unique needs.

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