As a contract manufacturer, you create products for many customers, each with unique requirements and uses of your equipment.
Regardless of facility size, productivity is typically driven by efficient documentation, automation and high levels of Overall Equipment Effectiveness (OEE).
For each customer, you need to deliver the highest quality products while maintaining compliance, reducing costs and keeping track of your equipment.
In Life Sciences, it is imperative to have low operating costs. However for contract manufacturing organizations, keeping costs low and prices competitive may mean the difference between thriving and going out of business. It is paramount to your success to have vendors that provide cost effective solutions. When it comes to your facility, you need a solution that delivers full functionality and performance while keeping your costs minimal and helping you to master complex equipment management.
Built for Life Sciences manufacturing, Blue Mountain Regulatory Asset Manager (RAM) tracks equipment lifecycles, easily integrates with manufacturing execution systems (MES) or laboratory information management systems (LIMS), manages compliance within your facility and provides on demand reports when you need them.
As a contract 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?
Manage Facility, Equipment and Instrumentation
Create and maintain comprehensive equipment lists that include availability, design capability and performance characteristics of equipment to meet the needs of your many customers.
Implement GMP-centered workflows, maintain detailed audit trails, and provide powerful reports during both FDA and customer audits.
Comply with Part 11, Part 58, Part 210, Part 211, Part 606 and Part 820
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.
Contract Manufacturer Customers
It doesn’t matter how good your product is if you cannot support it with good knowledgeable people who are willing to go out of their way to work with the clients. Your Blue Mountain engineers have been excellent in responding to our needs and concerns throughout the process, and most importantly as we finalized items for roll-out.
Pharmaceutical Contract Manufacturing Organization
Contract Calibration Company
PCI, a nationally recognized contract calibration service company with more than 10,000 assets and over 75 engineers and technicians on staff wanted to transition to a paperless environment that would be scalable to future satellite service centers as the company grows. In addition to calibration services this firm also offers other solutions including maintenance program administration service for FDA regulated companies. After evaluating several software options, including Maximo, SAP PM, and Datastream products, Blue Mountain’s Regulatory Asset Manager software was chosen.
Goals and Approach
The goal was to implement a new in-house maintenance & calibration program to address business changes, provide tighter control over their internal calibration and inspection processes and compliance, and better manage their costs. Future plans include providing interfacing the software with the accounting system.
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 of asset information via paperless change control processes
- Improved instrument availability via faster calibration turnaround times; for both internal test equipment and for customer instruments
- Better planning and scheduling for the department and the instrument owners has improved operations and productivity
- Quick access to business information has improved critical decision making
- Automated metrics or key performance indicators (KPIs)
- Full integration with the exiting web-base accounting system (Sage’s MAS500 software) which allowed for customer invoicing upon work order completion
Everything You Need to Know About Contract Manufacturing
Discover how RAM can be configured to meet your unique needs.