Blue Mountain Quality Resources - Life Science Asset Manager Software

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 since 1989, Blue Mountain Quality Resources offers a solution designed to address these specific challenges.

Harmonizing calibration, maintenance and validation

Blue Mountain Regulatory Asset Manager® is a comprehensive browser-based solution designed 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.

The software allows each discipline to work with assets in their own way and easily collect the type of information they require whilst still offering all the collaboration features expected from a single comprehensive solution.

• 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
• Forecast labour and parts requirements into the future to make better decisions about inventory requirements and hiring

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. Changes to any record type, from asset and event records to inventory and measurement data templates, are documented and controlled.

• Fully 21 CFR Part 11 compliant electronic records features with advanced electronic signature routing 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
• Trace where spare parts, calibration standards and other assets were used in work on assets, locations, batches or tests for a quick and confident impact assessment

Controlling business processes

Your business process rules can be mapped directly within Blue Mountain Regulatory Asset Manager, allowing technicians and engineers to focus on the assets with confidence that business processes will be followed. A practically unlimited number of business process rules can be defined to handle a broad range of circumstances.

For example, maintenance work on a non-GMP asset would likely have a different workflow than emergency work on critical GMP assets, requiring additional quality oversight and review. At each state in a business process rule, different fields can be required, enabled or disabled. Electronic signature requirements before the record can progress to the next state can be specified. Precedence on signatures can be enforced and the state can be configured to automatically advance once all required signatures have been applied.

Process control also extends to include the ability to prevent the use of standards that are out of calibration, past due or do not meet accuracy requirements. Process tolerances can be established for all instruments that will trigger immediate and automatic notification if an issue arises.

Before a lot is started, the computer will check the status of all assets used in that process and advise if any of the asset are past due for work, failed or have work coming up during the course of production of the lot. Training requirements and qualifications of employees and contractors can also be controlled and documented through Blue Mountain Regulatory Asset Manager.