Blue Mountain System

2024/07/11

Equipment that complies with good manufacturing practice (GMP) is essential for producing pharmaceutical products that are pure, safe and effective. The design, function, qualification and control of such equipment must meet high standards in the manufacture of these products. 

To prevent GMP equipment and facility risks, it is crucial to maintain and calibrate the equipment regularly and properly. This means that the equipment must be in a good working order, free from any faults, damages, or deterioration that could affect its performance and reliability. Maintenance and calibration should follow a predefined schedule and procedure that adhere to the manufacturer’s recommendations and the GMP requirements. Maintenance and calibration records should be maintained and reviewed to check the equipment status and functionality. This way, we can be proactively identified and fix any equipment problems, errors, or deviations that could jeopardize the product quality and safety. 

Amaran uses Blue Mountain RAM, a world-class calibration and maintenance management system, as one seamlessly integrated system. It ensures GMP compliance and provides built-in best practices for the Life Sciences industry. Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) combines the capabilities of an EAM (Enterprise Asset Management), CMMS (Computerized Maintenance Management System), and CCMS (Component Content Management System) increasing product/process quality and productivity.

2024-07-11T11:15:25+08:00