Asset Management Software for Medical Device
Learn how Blue Mountain RAM can help you ensure GMP compliance and maximize productivity and profitability in Medical Device manufacturing.
Integrate the full cycle of maintenance operations with world-class calibration management.
Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) integrates functionality for the full cycle of maintenance operations with world-class calibration management. Purpose-built for the Life Sciences industry, the software features built-in best practices designed to ensure GMP compliance and maximized productivity and profitability.
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 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.
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 organization.
Work planned on a regular schedule, or that only 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.
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 in Blue Mountain RAM 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. Robust workflow automation simplifies the creation of events for both planned preventative work and on demand corrective work; such as scheduled maintenance or on demand calibration.
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. Blue Mountain RAM features robust on demand business intelligence.
Everything You Need To Deliver Safe & Effective Products To Your Customers
Blue Mountain RAM gives you the necessary tools for mastering maintenance and calibration management of GMP equipment.
Electronic Records for GMPs
Centrally track critical asset information with records that capture all pertinent data, such as asset information, history, audit trail, 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. Manage the equipment lifecycle while complying with 21 CFR Part 11.
Built-in Best Practices
Get up and running quickly with industry best practices leveraged from over 1,000 validated implementations.
Electronic Work Plans
Detailed step-by-step tasks for performing work ensure that productivity and compliance are achieved. Provide technicians with the necessary SOPs and documents and record acceptance criteria.
Add Similar and Asset Enrollment
Built-in functionality streamlines the addition of new equipment and instruments into the system.
Storeroom functionality manages spare parts, re-order parts, and tracks like-for-like parts.
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.
Automatically provide a warning or lock down standards that are out of calibration or overdue for calibration.