Are Your Investigations Timely? - Inquiring Minds (Auditors) Want to Know
April 22, 2013 by Keith Kyle
It has been a while since my last blog entry given the busy year we've had here at Blue Mountain. So, I decided that the best way to kick-start my blog entries was to focus on a topic that I most enjoy writing about. That is, how technology can be applied to improve business practices and solve business problems. Specifically, I chose to blog about the use of Subscription-Based reports (more on what these are later) to monitor the progress of investigations...
Read More...Where Does The Calibration Group Work Best?
February 15, 2013 by Jim Erickson
There has been an excellent dialog going on the LinkedIn Pharmaceutical Calibration Group on where the calibration group works best - Quality, Operations or Engineering.
Read More...Election 2012 – Industry Expectations for the Next 4 Years
November 12, 2012 by Jim Erickson
The elections are over, our airwaves are free from political ads, and President Obama was elected to a second term. Regardless of where you stand on the political spectrum, the election results certainly affect our industry. Here are a few thoughts on the impacts.
Read More...Use Business Intelligence to Improve Productivity
November 2, 2012 by Administrative User
In my blog post Top 5 GMP Asset Management Trends in 2012, I discussed the trend of companies mining their data for meaningful Metrics and Key Performance Indicators. As the year has progressed, we have continued to see increased interest from our customers in this topic and in the tools to enable it.
Read More...Hot GMP Maintenance Topic: Work Plans
August 21, 2012 by Jim Erickson
One of the most oft cited GMP issues is not having sufficient work plans in place or not following the ones you do have. Many of the recent high visibility Warning Letters, 483’s and consent decree list inspection issues with procedures, with many coming under the realm of GMP Maintenance.
Read More...