Author: Jim Erickson

  • The Cancer Moonshot Summit

    In my previous blog, I discussed the announcement of Vice President’s, Joe Biden, cancer “moonshot.” After six months from the launch of the government’s moonshot, the United States has not yet doubled the rate of progress toward finding a cure as had hoped yet, there have been many efforts made with reference to the end goal. Since the announcement of the […]

  • Strong Adoption of EAM by the Biotech Industry

    There are several factors that have affected the growth and advancements of the Biotech industry over recent years. Over the last year in particular, we have seen a drastic increase in drugs and therapies being brought to market. It is evident that 2016 holds great opportunities for the innovation and production of novel drugs. Well-funded […]

  • Blue Mountain Applauds the Cancer Moonshot

    President Obama announced at the last State of the Union Address that Vice President, Joe Biden, will officially be leading the “moonshot” against cancer. Biden accepted this task, as a tribute to his son, Beau, who died of brain cancer this past May. On the day of his grieving, Biden “called for a national commitment […]

  • Compliance Series 6: Leveraging EAM Functionality to Manage Compliance Risks

    Now that I laid the framework for purpose-built EAM software and some core functionality requirements for regulated companies, I want to go into more detail about using EAM/CMMS features to manage compliance risks.  There are two important factors to note surrounding EAM/CMMSs in GMP environments: Maintenance and calibration work should be streamlined and simplified for […]

  • Compliance Series 5: Core EAM/CMMS Functionality for Compliance

    In the previous blog, I discussed the importance of using purpose-built software. Because we are a purpose-built EAM solution provider, we see many Life Sciences companies moving away from generic EAM/CMMSs and ERP modules to implement a truly purpose-built EAM, like Blue Mountain RAM. One of the biggest values of utilizing purpose-built EAM software is […]

  • Compliance Series 4: EAM/CMMS Purpose Built for Life Sciences

    Now that we’ve covered broader GMP issues in the previous 3 blogs, I want to discuss the overall role of an EAM/CMMS in managing compliance risks and some factors that come into play. In this blog and the upcoming blogs, we’ll cover purpose-built EAM/CMMS software, core compliance features and maintenance, calibration and validation functionality. — […]

  • Compliance Series 3: Monitor Quality with Metrics from EAM / CMMS

    In the previous blog in this series, I discussed the FDA’s new Office of Pharmaceutical Quality and its overarching goals.  There is no better summary of what the FDA hopes to achieve with the OPQ, than a quote taken from an FDA PowerPoint: “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high […]

  • Compliance Series 2: Focus on Quality Not Compliance

    The Office of Pharmaceutical Quality (OPQ), launched in 2015, will be used to carry out the FDA’s long term plan to establish a uniform quality program for drug manufacturers. The OPQ’s oversight will include both domestic and foreign facilities with the overarching goal to shift the mindset of pharmaceutical manufacturers from meeting compliance to developing […]

  • Compliance Series 1: Managing Compliance Risks with EAM

    In our previous blog series, we briefly explored the growing enforcement of the FDA. From 2007 to 2012, the number of warning letters given by the FDA drastically increased as the FDA became more aggressive. The focus of this blog series, Managing Compliance Risks with EAM, will take an in-depth look into the trends surrounding […]

  • Great Conversation at the 3rd Annual Blue Mountain Summit

    Our 3rd annual Blue Mountain Summit was a huge success! Over a two and a half day period, presenters covered topics such as paperless, mobile, compliance, ROI and software functionality. But this year’s big success was the customer to customer interaction that occurred outside of the presentations. One of the true values of the Summit […]