MENU Customers Biotech Medical Device Pharmaceutical Cell & Gene Therapy Contract Manufacturers Asset Management Software for Cell and Gene Therapy Learn how Blue Mountain RAM can help you ensure GMP compliance and maximize productivity and profitability in Cell and Gene Therapy Manufacturing. SUBMIT 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. Reach Desired Speed To Market Rapidly move therapies through the pipeline while meeting regulatory compliance with software that ensures GMP compliance and drives asset reliability and technician productivity. Blue Mountain RAM’s core functionality enables companies to efficiently manage asset life cycles, while providing the necessary tools to be GMP compliant and achieve data integrity. Onboard New Facilities & Scale Manufacturing Share information globally across facilities, analyze performance, and easily bring new facilities online. Replicating systems across facilities, and rapidly adding new assets can all be simplified and streamlined with Blue Mountain RAM. Blue Mountain RAM’s Asset Enrollment and Add Similar are robust functionality for onboarding new equipment and instruments – providing a streamlined means of bringing new equipment into the system. 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. Productivity-focused Interface Blue Mountain RAM features a productivity-focused interface & easy-to-use functionality that enables fast adoption for new users. A responsive design for any screen size enables fast access to records and pertinent information. Blue Mountain RAM’s productivity-focused interface drives productivity by providing tools to streamline work execution. 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. Get Up and Running Quickly Rapidly implement Blue Mountain RAM by leveraging industry Best Practices. Blue Mountain RAM’s Cloud eliminates the need for upfront investment in software, licenses, and hardware while providing a robust & highly available enterprise asset management solution built to support cell and gene therapy manufacturing. Request a software demo! SUBMIT or Call Sales (800) 982-2388 Our Customers Say It Best 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 in cell and gene therapy manufacturing. 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 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. A few of our Cell & Gene Therapy Customers Request a software demo! SUBMIT or Call Sales (800) 982-2388 SOLUTIONS ASSET MANAGEMENT MAINTENANCE MANAGEMENT CALIBRATION MANAGEMENT CLOUD INFRASTRUCTURE IMPLEMENTATION OPTIONS CUSTOMERS BIOTECH MEDICAL DEVICE PHARMACEUTICAL CELL & GENE THERAPY CONTRACT MANUFACTURING ABOUT CONTACT 800-982-2388 Sales: sales@coolblue.com Technical Support: techsupport@coolblue.com Human Resources: hr@coolblue.com Legal Notices | Privacy Policy | GDPR | Privacy Shield Notice of Certification © 2020 Blue Mountain Quality Resources, LLC. Blue Mountain Quality Resources, Blue Mountain Regulatory Asset Manager and Calibration Manager are registered trademarks of Blue Mountain Quality Resources, LLC