Author: Drexel Rothrauff

  • An Internal View of NCSLI

    Marcus McNeely, who is a long-time Blue Mountain employee, recently accepted the role of Vice President of the Northeastern US Region of The National Conference of Standards Laboratories International (NCSLI).  Marcus has been an active volunteer in NCSLI for many years and previously served as the Chair of the NCSLI Healthcare Metrology Committee (the 151 […]

  • The 5 Steps to Upgrading your CMMS

    It is critical for Life Sciences companies to upgrade to the latest version of their CMMS software on an incremental basis.  Many new releases include critical patch updates, may improve current business processes or offer additional software functionality. Upgrading also offers the ability to maximize return on investment with the software. With a critical upgrade […]

  • Top 5 Measurable Costs of a Warning Letter

    Top 5 Measurable Costs of a Warning Letter In part one of this two part blog series, we laid out the top 5 immeasurable costs to an FDA warning letter; including reputation damage and competitor leverage (read part 1 here). In this part, we will discuss the most common and top costs to receiving a […]

  • Vital Keys to Maximizing Outsourced Maintenance with an EAM, CMMS or CCMS

    Is your company truly benefiting from outsourcing maintenance and calibration? One of the increasing trends that we have witnessed is the growing demand for outsourced preventative maintenance and calibration. Life Science companies across the country are more frequently and consistently utilizing calibration labs and contractors to perform work on their facility’s equipment in order to […]

  • Top 5 Immeasurable Costs of a Warning Letter

    A Warning Letter Form FDA 483 “Inspectional Observations,” is a form used by the FDA to communicate concerns and document observations made by the FDA representative(s) during the inspection of a Life Sciences facility. No one can really quantify the cost of a warning letter, not even an average cost, due to an immense number […]

  • 3 Ways to Increase Profitability and Compliance

    The Pharmaceutical, Biotech, and Medical Device industries are continuously hounded by tightening regulations, warning letters and fines.  With heightened FDA enforcement, most Life Sciences companies focus on meeting FDA regulations rather than improving the overall quality of their product. By focusing on improving quality from product inception, Life Sciences companies will naturally increase their compliance […]

  • Top 5 Reasons to Attend SMRP’s Annual Conference

    Society for Maintenance and Reliability Professional’s (SMRP) Annual Conference takes place this year in Indianapolis, Indiana from October 14-16, 2013 with a focus on productivity, best practice solutions, and emerging trends in 5 great pharmaceutical and biotech presentations. The Pharmaceutical and Biotech Special Interest Group (SIG) gains additional attention this year in the conference with […]