Blue Mountain Regulatory Asset Manager

A comprehensive asset management solution for life science companies
Organizations have long struggled to find a balance between achieving regulatory compliance and quality excellence while also maximizing productivity and profitability. With the increasing pressure to harmonize systems across departments and functions, this challenge becomes even more acute. Developing technologically advanced software applications for asset management at FDA-regulated and ISO-compliant companies since 1989, Blue Mountain Quality Resources offers a solution designed to address these specific challenges.

Blue Mountain Regulatory Asset Manager is a comprehensive integrated browser-based solution designed from inception to enable the collaboration of maintenance, calibration and validation personnel. This collaboration allows all asset owners, technicians, and quality managers to work together to maintain assets and processes in a controlled and validated state. At the same time, the software reflects the reality that calibration, maintenance, and quality personnel each have their own unique requirements and ways of working with assets. Therefore, no group need compromise on their productivity.

Regulatory compliance taken as seriously as you do
Blue Mountain Regulatory Asset Manager satisfies the strict regulatory requirements of life science companies not as an add-on module but as an integral part of the application. Being tightly integrated with the entire application means that changes to any record type, from asset and event records to inventory and measurement data templates, are documented and controlled. Records, including standards and event templates, must pass
through their appropriate approval process and be in an "approved" state before they are available for use by other records. The ability to build business process rules into the approval process improves compliance while minimizing the impact compliance measures can have on overall productivity and efficiency.

• Fully 21 CFR Part 11 compliant electronic records features with advanced electronic signature routing, including configurable asset lifecycle states and approval routes to expedite an asset's return to full production within a validated state
• GxP compliance includes best-in-class calibration functionality including sophisticated standards tracking, streamlined measurement data collection and complete notification system for failed calibrations and out of tolerance readings
• Control over the validated state with management of qualification activities and regulation of activity that requires change control procedures

Harmonizing calibration, maintenance and validation
With Blue Mountain Regulatory Asset Manager, calibration, maintenance and validation professionals can finally collaborate within a single system without compromising productivity or compliance. The software allows each discipline to work with assets in their own way and easily collect the type of information they require while still offering all the collaboration features expected from a single comprehensive solution. Blue Mountain Regulatory Asset Manager's collaboration features provide significant advantages over the paper-based workarounds that are in place in most organizations.

• Eliminate multiple applications for managing separate engineering functions
• Schedule calibration, maintenance and validation activity in unison to minimize downtime
• Configure automatic notifications across functions according to business process rules
• Integrate Blue Mountain Regulatory Asset Manager with other enterprise systems (including ERP and document management systems) to facilitate information flow and reduce duplicated entry