Success Story
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.
Goal 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 Regulatory Asset Manager 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 Regulatory Asset Manager’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 Regulatory Asset Manager’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 Regulatory Asset Manager’s integrated reports were also used to create custom instrument labels, thus eliminating the hand-written ones they had been using.
Blue Mountain Regulatory Asset Manager’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 Regulatory Asset Manager across their enterprise.
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.
Goal 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.
