The challenge is finding a paperless solution that allows your technicians to access and record data in the field. To effectively go mobile and drive toward paperless, your processes, workflows and documents must be streamlined, automated and accessible everywhere your technicians work.
Out of the box, Blue Mountain Regulatory Asset Manager offers a maintenance and calibration solution that supports a variety of mobile devices including Windows Tablets and Apple iPads. Adding mobile devices to your Blue Mountain RAM installation allows you to:
Discover how Blue Mountain RAM can take you mobile while meeting your unique calibration and maintenance needs. With implementation options ranging from pre-configured templates to custom configuration, we can take you from Project Assessment to Go Live in as little as 3 months.
Our state-of-the-art clinical manufacturing center requires regulatory compliance across a variety of products including human cells and tissues, medical devices, and other biologics. Blue Mountain shares our commitment to quality and compliance, so with the robust asset management functionality of Blue Mountain Regulatory Asset Manager it seemed like the natural choice.
Kevin B. Johnson, PhD
Director of Regulatory Affairs,
Wake Forest Institute for Regenerative Medicine
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.
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.
Goal 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 Result
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: