Tag: Quality

  • Utilizing Blue Mountain RAM to Enhance Change Control Processes

    It is a requirement for organizations to track changes in a GMP environment. Effective and efficient change control processes are key to achieving quality and compliance. At this month’s Blue Mountain Customer Lab, we took a few polls of our audience to determine how customers are currently tracking changes. The results were as follows: 39% […]

  • Could The United Kingdom Be The Next Life Sciences Hub?

    Implications of the Historic Brexit Verdict Since the final votes of the Brexit were counted, a majority of the UK’s decision to leave the EU has appeared pessimistic for the Biotech and Pharmaceuticals industries. As a result, there has been very little talk about any positive outcomes for the Life Sciences. Yet, can we truly […]

  • Lean Manufacturing Series: Lean in the Life Sciences Industry

    Lean manufacturing is becoming prominent in the Life Sciences industry. The model has seen much success in a variety of other industries. This blog series will focus on revealing how Enterprise Asset Management (EAM) can drive lean. We will shed light on lean in the Life Sciences industry; digging deeper into the understanding of how […]

  • The Key to Improving Quality Culture

    Culture.  With regards to the FDA, this word typically refers to growing microorganisms or other living materials in a medium.  You will also find the word “culture” in The FDA’s Draft Guidance for the “Request for Quality Metrics.”  The word is used 10 times in fact.  In an effort to promote risk based inspections and […]