Comprehensive Software for Medical Device Asset Management

Leverage GMP-centered functionality

Meet Part 11, Part 820, and ISO 13485 compliance. Blue Mountain RAM features Part 11 workflow automation, electronic signatures, built-in security controls for medical device company users, and detailed audit trails. The software is designed to be used in compliance with the FDA’s GMPs and ISO 9000. Manage complete equipment lifecycles in Blue Mountain RAM.

Blue Mountain Built-in measurement data calculations

Best-in-class measurement data collection

Built-in measurement data calculations and As Found/As Left save technicians time and ensures accuracy. Blue Mountain RAM features reusable measurement data templates, built-in measurement uncertainty calculators, and multi-level tolerances. Standards are tracked on calibration work and can be shared globally across facilities in your medical device organization.

Streamline scheduling

Work planned on a regular schedule or that occurs as needed is configured to meet your SOPs, business rules, and GxP requirements. Simplify the creation of events for both schedule-based planned work and on-demand corrective work with Blue Mountain RAM’s robust workflow automation.

Everything you need to bring safe & effective therapies to market

Blue Mountain RAM gives you the necessary tools for mastering maintenance and calibration management of GMP equipment.

Electronic Records

Centrally track critical asset information such as asset information, work performed, and equipment status in a GMP environment.

Part 11 Workflow Automation

Automatically route work requests for approval, generate new work orders, and notify technicians of upcoming work, while complying with 21 CFR Part 11.

Robust Audit Trails

Permanently capture old and new values, audit reason, date and time, and the name of the user making changes.

Electronic Work Plans

Provide technicians necessary SOPs with detailed step-by-step tasks and the ability to record acceptance criteria to ensure productivity and compliance.

Add Similar and Asset Enrollment

Built-in functionality streamlines the addition of new equipment and instruments into the system.

Storeroom Management

Storeroom functionality manages spare parts, re-order parts, and tracks like-for-like parts.

Measurement Data

Sophisticated measurement data collection capabilities saves technicians time and ensures accuracy.

Out Of Tolerance

Automatically trigger Out of Tolerance notifications when they arise – ensuring the results are not overlooked.

Standards Management

Automatically provide a warning or lock down standards that are out of calibration or overdue for calibration.

Extend equipment lifecycles

Harmonize equipment maintenance and calibration, spare parts management, scheduling, and work execution functionality to extend equipment lifecycles and drive lower production costs. Electronic records in Blue Mountain RAM track pertinent data of GMP equipment and provide visibility into asset performance from induction to retirement.

Manage complex processes

Overcome the many logistical challenges of tracking and documenting complex manufacturing processes. Change Requests functionality helps manage process change, such as tracking equipment change, settings, and parameters. Electronic Work Plans provide detailed step-by-step tasks for performing work and feature the ability to record acceptance criteria and daily steps.

On demand business intelligence

Blue Mountain RAM features robust, on demand business intelligence. Gain in-depth visibility into assets, manufacturing processes, and all facilities across the enterprise. Improve control of compliance across organizations and get the greatest return on investment.

Achieve GMP compliance and maximize profitability with Blue Mountain.

Our industry-leading software was designed for the Life Sciences. We're here to help you manage the complete lifecycle of your assets and put best practices in place.

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