Multi-Site Biotech Manufacturer
Blue Mountain has assisted with the implementation of Blue Mountain RAM at a multi-site biotechnology based organization with an FDA approved product to treat life threatening illnesses. In this instance, Blue Mountain RAM is centrally hosted for multiple facilities & locations throughout the United States. Several thousand assets currently reside within the product’s database and these records serve as a focal point for managing work (maintenance, calibration and validation). Numerous maintenance & calibration technicians along with other personnel depend on access of this application every day. Estimated dependency of regular system users is 15-20 at any one time.
Goals and Approach
A need was identified by this organization to use a validated and Part 11 compliant solution for the purposes of managing work against assets. During early interaction with Blue Mountain, it was discovered that a previous implementation of a competing Computerized Maintenance Management System (CMMS) product was unsuccessful. As an alternative, this organization was evaluating the idea of managing maintenance & calibration management using their existing Enterprise Resource Planning (ERP) system. However, the capabilities fell short upon examination. Blue Mountain RAM was a favored alternative to the pre-existing options due to the purpose built & best-in-class functionality of this software application along with Blue Mountain’s dedication to the life science industry. The initial scope was to include two facilities but has now grown into a four site project.
The Solution and Results
Dependency on Blue Mountain RAM has continued to increase since the time of implementation. The initial project scope included central tracking of organizational assets and management of work schedules and relevant historical data. Since then, there have been initiatives set in motion to be paperless, add additional facilities to the active and validated instance and provide work request access to all employees. This organization has experienced several enhancements to their pre-existing processes. Electronic signatures are in use to better manage review of work in a streamlined fashion. As additional data is collected (i.e. as-found/as-left calibration values, work requests, etc) there are more instantaneous ways to access historical data and run reverse traceability checks, thus increasing compliance. In addition, there has been an ability to harmonize various locations and bring asset management down to one common level amongst sites. Increased efficiency & compliance combined with a better ability to make valid business decisions have provided ROI that will last for years to come.