Biotech

Asset Management Software for Biotech

Your ultimate goal is to introduce a new, safe, effective therapy to market. Getting there involves sophisticated processes and products that must meet the highest of standards.

Flexible and highly configurable, Blue Mountain Regulatory Asset Manager® (Blue Mountain RAM) was designed for Biotech. It enables companies of every size and stage to put best practices in place and helps you coordinate and automate your work at a price point even early stage start-ups can handle. Because the system is highly configurable, it allows for an easy transition from the simpler needs of R&D to the more complex requirements of full-scale, multi-site production.

Blue Mountain Quality Resources®:

  • Offers deep Biotech domain expertise
  • Develops functionalities specific to the biotech industry
  • Offers specific solutions for small, medium and large-sized firms

As a Biotech manufacturer, you can implement Blue Mountain RAM using either our Best Practices Template or a Custom Configuration. With a full suite of services, we can take you from Project Assessment to System Implementation in as little as 3 months.

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Lab, Analytical, and Process Instruments Management

Best-in-class functionality designed specifically for Biotech needs and equipment include enhanced electronic logbooks, process measurement data templates and custom non-conformance workflows.

 

Scale with Growth

As a highly configurable solution, Blue Mountain RAM allows for an easy transition from the simpler needs of R&D to the more complex requirements of full-scale, multi-site production. Use the software during clinical trials and easily expand when you reach full production – driving standardized and compliant processes.

 

Part 11, Part 58, Part 211 and Part 606 Compliance

Designed to be used in compliance with ISO 9000 and the FDA’s GMP & QSR regulations. Gain the necessary technical controls to enable Part 11 compliance.

Our Customers Say It Best

A few of our Biotech Customers