Medical Device Manufacturers

As a medical device manufacturer, you leverage the latest technologies to innovate state-of-the art devices ranging from simple to complicated and diagnostic to therapeutic.

Designing and manufacturing medical devices involves sophisticated processes that require higher precision, tighter tolerances, greater throughput and GMP compliance – all of which drive your need for a reliable calibration, maintenance and validation solution.

That’s where Blue Mountain Regulatory Asset Manager (RAM) comes in. Our best-in-class software – coupled with exceptional service and support – enables you to put industry standard calibration and maintenance best practices in place. Most importantly it helps you comply with GMP regulations. Your operation will become more productive and efficient. And the cost pressures you face from global competition, increased regulatory demands and healthcare reform will be minimized. Implemented across your organization, Blue Mountain RAM can actually help improve corporate profitability.

As a Medical Device 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?

Streamline Calibration and Maintenance

Automate business processes with RAM’s best-in-class functionality that is specific to your needs including meter-based or time-based scheduling, process or dimensional measurement data templates and in-depth standards traceability.

Standardize Processes

Drive consistent processes across facilities to increase productivity, reduce costs and gain a competitive edge.

Comply with Part 11, Part 820 and ISO 13485

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.

Medical Device Customers

By bringing together calibration and maintenance management into a single platform, Blue Mountain Regulatory Asset Manager will allow us to maintain the high-quality of our equipment process and procedure control. This will enhance collaboration and coordination of activity across departments.

Humberto Reyes
Chief Operating Officer,
Cepheid

Success Stories

 

Global Medical Device Firm

Customer Profile

This flagship facility of a top-tier global medical device manufacturer was managing calibration work and schedules for 50,000+ instruments.  As a result, hundreds of thousands of calibrations a year are performed by a staff of 15 calibration technicians doing most of the work in house. They are also considered the leader in metrology best practices within their organization’s many global facilities.

Goals and Approach

The client had a compliance risk with their legacy Computerized Calibration Management System (CCMS) and the corporate solution for maintenance did not have the calibration tracking and management capabilities they were seeking.  The client identified key requirements around FDA compliance, metrology data tracking and IT architecture.  

The new system had to have a computer system validation methodology associated with it that had been proven in the real world.  It also had to include 21 CFR Part 11 compliant Electronic Signature that will allow them to increase efficiencies by implementing a paperless system for their entire metrology department.  

The solution had to include tools to evaluate measurement data for trending and to identify Out Of Tolerance (OOT) events.  Ideally the system could be configured to send notifications out to users and instrument owners for key events such as OOT and instruments that were past their calibration due dates.

The Solution and Result

Blue Mountain RAM was selected and has exceeded the customer’s expectations on all of their requirements in addition to several areas outside those original requirements.  By partnering with Blue Mountain the client was able to leverage Blue Mountain’s in-house expertise for configuration and computer system validation and have the system expertly validated following the GAMP guidelines in a very timely and efficient manner.

Utilizing Blue Mountain RAM’s configurable business rules, in combination with 21 CFR Part 11 Electronic Signature functionality, allowed the client to implement a paperless system for their daily operations.  The Electronic Signature and configurable Business Rule Record Routing also allowed the company to take advantage of Blue Mountain RAM’s free unlimited Requestor Licenses to eliminate the need for an external request system.  Utilizing the software’s request system increased compliance by giving them full traceability from the discovery of an issue on GMP critical equipment through resolution within a validated system.  Efficiency gains were realized throughout their business process by having Blue Mountain create and implement several Key Performance Indicator Reports.  Blue Mountain RAM’s integrated reports were also used to create custom instrument labels, thus eliminating the hand-written ones they had been using.  

Blue Mountain RAM’s architecture gave the client confidence in the long-term stability and viability of the application.  The client is making plans for facilities around the globe to access their own data with this instance of the application, allowing the company to exponentially increase their ROI by leveraging their investment in Blue Mountain RAM across their enterprise.

Medical Device Manufacturer

Customer Profile

A global leader in medical device manufacturing with over 5,000 employees, five manufacturing sites and upward of 50,000 assets globally needed to harmonize its calibration and maintenance management programs.   This company manages work and scheduling for over 100,000 calibration and maintenance events annually with the majority of the work being performed in-house using internal technicians. The individual sites vary in size, amount of assets and resources to support those assets and associated service events. They have more than 35 calibration and GMP maintenance team members.

Goals and Approach

Prior to implementing Blue Mountain RAM, the company was using a variety of software applications at the different sites to manage its maintenance and metrology programs. All of the systems were paper-based and inefficient. Each site had independent programs, processes and practices, which were inconsistent between sites.

Blue Mountain Quality Resources was contacted by their corporate site management and asked to provide a Enterprise Asset Management (EAM) solution that would harmonize all of the sites management, scheduling and performance of the assets service events.  Blue Mountain Quality Resources took on the project to improve the customer’s corporate Metrology and Maintenance program compliance. 

The Solution and Results

Blue Mountain Quality Resources worked with the customer to successfully implement the application allowing the company to use the validated software application globally. Blue Mountain Quality Resources partnered with the users to identify their user requirements, process needs and configuration requirements to achieve global standardization and compliance.

The implementation of Blue Mountain RAM has achieved:

  • Streamlined work flows resulting in productivity gains
  • Reduced equipment and instrument downtime
  • Increased organizational efficiency
  • Harmonized procedures and practices
  • Improved accountability of assets
  • Improved GMP compliance
  • Increased asset owner participation
  • Improved communications and collaboration
  • Reduce IT costs by consolidation and standardization

Blue Mountain Quality Resources continues to work with this customer to identify new requirements and works to meet those needs as this medical device continues to expand globally.

Everything You Need to Know About Medical Device

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