MENU 21 CFR Part 11 Compliance Asset Management Maintenance Management Calibration Management Cloud Infrastructure Implementation Options 21 CFR Part 11 Compliance Compliance requirements can be costly and time consuming – during initial configuration of a software and on-going usage. Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) is purpose-built to streamline and simplify asset management, maintenance, and calibration for companies while providing the necessary tools to manage compliance, including customizable workflows with e-signature capability. Here are a few examples of Blue Mountain RAM’s built-in features: Security Access limited to authorized individuals User Authentication Access credentials must be unique to each user Electronic Signatures 2 components required for initial signing in a session Signature reasons Associate e-signature to a specific record Audit Trails Old/New values Audit reason Date & Time stamp Name of person making change Validated System GAMP 4 & GAMP 5 approach 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