Blue Mountain Quality Resources, Inc. published a new white paper which discusses how the FDA’s Office of Pharmaceutical Quality and recent budget changes are affecting the regulation of Life Sciences companies. Through an in-depth look into asset-related risks and current trends surrounding FDA inspections and product recalls, this white paper identifies key EAM/CMMS needs and functionality that pharmaceutical, biotech and medical device companies can implement to better manage compliance risks.
“With the FDA’s proposed inspection techniques and their focus on a standardized quality rating for facilities, it is increasingly important for companies with GMP manufacturing to utilize a purpose-built EAM/CMMS solution which is designed from the ground up with compliance based functionality and includes the necessary reporting capabilities to monitor quality metrics.” said Jim Erickson, President of Blue Mountain Quality Resources.
The white paper is titled “Managing Compliance Risks with EAM/CMMS” and can be downloaded here.
About Blue Mountain Quality Resources
Blue Mountain Quality Resources is the leading developer of industry standard asset management products and services—designed exclusively for the Life Sciences industry since 1989.
The company’s Blue Mountain Regulatory Asset Manager® was the first regulatory asset management system, designed specifically as a harmonization of calibration, maintenance and validations systems into a single comprehensive solution for Life Sciences companies.
For more information, contact Curtis Harrison at 814-234-2417 or ceharrison@coolblue.com.
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