Blue Mountain Quality Resources has been developing technologically advanced software applications for FDA-regulated biotech companies for over 15 years. The company offers complete solutions ranging from single-site software implementation, training and validation, to global, multisite turnkey packages. Designed for how work is done, these solutions improve compliance and enhance productivity with built-in flexibility to satisfy the needs of individual biotech companies.
Products and ServicesBlue Mountain Regulatory Asset Manager is a comprehensive, integrated, browser-based solution designed from inception 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. At the same time, the software reflects the reality that calibration, maintenance, and quality personnel each has its own unique requirements and ways of working with assets. Therefore, no group needs to compromise on its productivity. As a single solution, the software addresses the Facilities and Equipment subcategory of QSIT, with a strong systems-based approach.
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. Being tightly integrated with the entire application means that changes to any record type, from asset and event records to inventory and measurement data templates, are documented and controlled. Records, including standards and event templates, must pass through their appropriate approval process before they are available for use by other records. The ability to build business rules into the approval process improves compliance while minimizing the impact it can have on overall productivity and efficiency.
Calibration Manager is an industry standard, single-point Computerized Calibration Management System (CCMS) for the biotech industry. With over 1000 validated implementations, Calibration Manager was designed for calibration professionals to meet the strict regulatory requirements in the biotech industry.
Enterprise Calibration Manager offers a solution for companies that want to standardize on a single calibration management system across multiple sites. In a typical installation, Enterprise Calibration Manager is hosted on a centralized server and used by working groups throughout the entire enterprise. The software enables each working group, regardless of location, to have its own dataset configured to its specific needs, whether it is custom fields, different language, etc.
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