Blue Mountain Quality Resources

Unique Needs of Contract Manufacturers: Purpose Built EAM & CMMS

In the previous blog, Unique Needs of Contract Manufacturers: Differentiating Factors, we outlined the specific and unique challenges of Contract Manufacturers (CMOs) when it comes to GMP equipment maintenance in a facility. To give a brief recap of the last blog, CMOs serve multiple customers in a highly competitive landscape. This creates a list of distinct requirements when it comes to using an asset management solution.

Blue Mountain Regulatory Asset Manager (RAM) is purpose-built for the Life Sciences industry. In addition to being built for the Life Sciences, Blue Mountain RAM includes a number of features that specifically target the needs of Contract Manufacturers. As an enterprise asset management solution, CMOs can rely on Blue Mountain RAM’s functionality to help them serve their many customers and remain competitive.

Below is a list of the needs of CMOs from our previous blog and how Blue Mountain RAM addresses each of these needs. For more detail on each bullet point, you can read the previous blog here.

EAM & CMMS Needs of Contract Manufacturers and how Blue Mountain RAM targets each:
CMO Need	Blue Mountain RAM Solution
Complex Equipment Lists	Blue Mountain RAM provides a robust facility, equipment, instrumentation management system – driven by the QSIT approach to create and maintain comprehensive equipment lists including availability, design capability and performance characteristics of equipment.
Equipment History and Statuses Stored in Batch Records	Blue Mountain RAM delivers a GMP centered solution that utilizes processes and lot functions to store history and status of equipment used for each batch in a CMO’s batch record management system.
Recipe and Batch Automation	Blue Mountain RAM provides the ability to create snapshots of equipment layout, configuration and usage for any given time so that CMOs can integrate data with electronic batch records.
Streamlined and Frequent Audits	Blue Mountain RAM maintains a detailed audit trail, GMP centered workflows and powerful reporting capabilities so that Contract Manufacturers gain fast access to equipment records and audit trails during both FDA and customer audits.
Equipment Configurations	Blue Mountain RAM includes powerful tracking of equipment configurations including: – Frequently Changing Physical Locations – Control System Parameters – GMP Change Control – Equipment Traceability – where used – lot, batch, etc. – Manage Corrective / Preventive Maintenance, Calibration and Validation With these features, CMOs can cultivate detailed specs for developing customer processes and marketing their capabilities.
Extend Equipment Lifecycle	Blue Mountain RAM harmonizes equipment maintenance and calibration, spare parts management, scheduling and work execution functionality to extend equipment lifecycles so that CMOs can significantly lower production costs.

When it comes to a highly competitive landscape, CMOs choose Blue Mountain RAM because it is a purpose-built asset management solution. CMOs need a solution that delivers maximum value for their given requirements – without including non-industry associated features that are not directly related to the needs of CMOs.

Blue Mountain RAM can maximize your investment by increasing productivity and aiding to cut facility costs with functions such as: