Whether you’re a small contract laboratory, a mid-sized specialty company, or a global, multi-site manufacturer, the pressure to do more with less is universal.
Your sophisticated and diverse instrumentation requires tighter tolerances than ever before. Your product quality and process reliability are paramount. And your equipment and facilities need to be maintained to the highest standards. To thrive, you have to find better ways to automate your work and collect field data.
Pricing constraints, global competition, reduced capital budgets – and especially increased enforcement activity by the FDA – all mean you need to be more productive, more efficient and 100% compliant. Blue Mountain Regulatory Asset Manager (RAM) was designed with the Pharmaceutical industry in mind. It allows you to put Best Practices in place as prescribed in ISPE and NCSL’s Guides to Maintenance and Calibration. In essence, it helps you do more with less.
As a Pharmaceutical 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.
Why Blue Mountain RAM?
Integrate GMP Asset Management
Combine calibration and maintenance into a single software solution to drive productivity and lean manufacturing. Connect RAM with external applications to streamline manufacturing processes (MES & LIMS) and accounting (ERP Systems).
Improve Quality and Process Reliability
Configure Blue Mountain RAM to streamline work using meter-based or time-based scheduling and provide paperless SOPs and measurement data templates to reduce scrap and errors.
Comply with Part 11, Part 58, Part 210, Part 211 and ICH Q8, 9 & 10
Gain the necessary technical controls to enable Part 11 compliance. Designed to be used in compliance with ISO 9000 and the FDA’s GMP & QSR regulations.
We have set aggressive goals for Facilities and manufacturing equipment management, including the implementation of a more proactive Total Productive Maintenance (TPM) approach, Blue Mountain Regulatory Asset Manager will enable us to meet our goals, harmonize all activity around equipment management in a single application and streamline processes while satisfying regulatory requirements.
A multi-billion dollar business unit of a global pharmaceutical company with more than 10,000 assets and 10+ calibration technicians, administrators, supervisors and managers wanted to create a new in-house paperless metrology program. After evaluating software options, they selected Blue Mountain RAM. In addition to best-in-class calibration functionality, it was important the vendor have experience integrating their solution with SAP PM in a validated environment.
Goals and Approach
The goal was to implement a new in-house metrology program to address business changes, provide tighter control over their internal calibration processes and compliance, and better manage their costs. Future plans include providing metrology services for other facilities within the company and/or provide a validated Computerized Calibration Management System (CCMS) platform for other facilities to share.
The Solution and Results
The company has successfully implemented a paperless calibration management program using Blue Mountain RAM. The software has allowed them to accomplish their pre-implementation goals and objectives:
- Improved management/accuracy of asset information
- Improved instrument availability via faster calibration turnaround times
- Better planning and scheduling for the department and the instrument owners has improved operations and productivity
- Better processes and procedures have enhanced compliance
- Quick access to business information has improved critical decision making.
Pharma Research Organization
This newly developed single-site laboratory focuses on scientific discoveries in regenerative medicine. This organization understood the importance of managing their critical & non-critical assets in a way that reflected their overall attitude towards operational cleanliness, compliance and facility management. An opportunity to begin managing assets without relying on paper and spreadsheets was a driving factor in the decision to purchase Blue Mountain RAM. The idea of putting a validated and paperless Part 11 compliant software application to use was well received by management and end users alike.
Goal and Approach
Most important to this customer was a solution that could be implemented with minimal effort but still grow and expand over time. The customer was able to capitalize on a pre-built configuration that also allowed a large number of template reports to work with/without alteration. These reports provide indicators and metrics relevant to the work performed, actively being performed and already performed.
Blue Mountain assisted with the implementation and the software is installed, configured and validated on local servers. This customer’s instance requires little to no daily system maintenance aside from adding/removing users, modifying queries, etc. At the moment, a few hundred assets reside within their database. A few users access the application on a regular basis.
The Solution and Results
Since implementation, the number of assets has grown significantly. The single concurrent user license was recently increased to five users. Because of Blue Mountain RAM, this customer has been able to begin laboratory operations with a best-in-class asset management solution designed specifically for the Life Science industry. Their ability to manage relationships between equipment, work to be performed, ad-hoc work and export data to make valuable business decisions ensures their return on investment has already begun.
Compliance is also a non-issue. Blue Mountain RAM allows users to query data and open appropriate records on demand, which is extremely helpful in audit situations.
Everything You Need to Know About Pharmaceutical
Discover how RAM can be configured to meet your unique needs.