Blue Mountain RAM
Blue Mountain Regulatory Asset Manager is an integrated GMP solution designed specifically for life science organizations.
Organizations like yours have long struggled to find a balance between achieving GMP compliance while maximizing productivity and profitability. Blue Mountain Regulatory Asset Manager was designed from inception to achieve the dual goal of compliance and productivity.
GMP asset management is a complex task with multiple layers of coordination required between the maintenance, calibration and quality groups. Blue Mountain RAM’s rich functionality enables all groups to work together to maintain assets and processes in a validated state. The application is designed specifically for each group’s personnel to work in their own unique work requirements – so no group needs to compromise on their productivity.
Maintenance Productivity and Compliance
- Automate maintenance work management
- Electronic work request, work orders, scheduling and histories
- Electronic Work Plans
- Integrated spare parts inventory
- Integrated Purchasing
- Vendor and Service Contract management
Calibration Productivity and Compliance
- Paperless calibrations
- Measurement Data Templates
- Sophisticated Standards tracking
- Multi-level tolerance levels
- Automatic Out Of Tolerance and Failure Notifications
GMP Compliance Benefits
- Configurable Work Flows with Part 11 electronic signatures
- Full process and record change control with Audit Trails
- Record reporting, retention and archive capabilities
Manage Your Entire Asset Life Cycle
Blue Mountain RAM manages your entire asset life cycle. Whether production equipment or process and lab instrumentation, GMP’s prescribe a complete life cycle approach to asset management. FDA’s Quality System Inspection Technique approach mandates a quality systems approach for Facilities and Equipment, from selection, installation and qualification to operation, maintenance and calibration, their use and history must be maintained.
- Manage and maintain Master Records under change control
- Maintain History records electronically - asset induction through retirement and disposition
- Control use of equipment and instrumentation
- Quickly query and report on all records, anytime, anywhere
Part 11 Work Flow Management with Electronic Signatures
GMP automation requires strong tools for managing work flow. Blue Mountain RAM’s 21 CFR Part 11 compliant Business Process Management (BPM) functionality is completely configurable to match your specific processes. Any process in the software can have a work rule defined for it to manage that process ensuring complete compliance.
Process and record life cycles are easily managed with Blue Mountain RAM. Many actions that were once done manually can now be automated in seconds and minutes instead of hours and days. You can now control record and process states, application of electronic signatures and trigger automatic notifications.
- Automate work documentation
- Enforce Standard Operating Procedures (SOP) and processes
- Sign records electronically – at different record states and times, by different personnel
- Configurable to your processes

Integrated EAM or Stand Alone CMMS/CCMS
With robust best-in-class capabilities in both calibration and maintenance, many companies implement Blue Mountain RAM for a single purpose only as CCMS or CMMS (calibration or maintenance management). Flexibility to use only the functionality you need. Justification is simplified when significant productivity gains can be achieved with paperless calibration or automated maintenance management.
State Of The Art Architecture Reduces Costs
Whether using Blue Mountain RAM as an EAM or single point CMMS/CCMS, its 100% web based architecture yields important benefits when it comes to deployment. By design, it minimizes validation effort and IT desktop requirements. Its rich 3rd generation browser User Interface responds like a desktop application but without the hassle. Its database and middle tier are designed for redundancy and scalability that you demand for mission critical GMP applications. It’s completely configurable without code changes for streamlined GAMP 5 approaches to installation and qualification.
- Access from anywhere, anytime
- Minimize qualification and validation efforts
- Reduce deployment costs
- No need to run Citrix or other limiting technology
- Scalable for performance and redundancy
- Host in your private cloud
Integration With Other Enterprise Applications
Sharing calibration and maintenance information between other Enterprise Systems has become routine. The benefits of sharing this data can have a significant and positive effect on your company’s bottom line. In Life Science companies, integration with other systems including ERP, LIMS and MES is an important way to further enhance productivity and compliance.
Blue Mountain RAM has an Application Programming Interface available for tightly integrating systems. For sharing of data one way from Blue Mountain RAM, such as equipment or instrument status to an MES or LIMS system, a simple database view can be created proving highly cost effective.
- Proven API for “real time” data exchange
- Simple database table views of one way data out
- Integrate with: SAP, LIMS, MES, QMS, Document Management, Inventory & Purchasing