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Clear Blue Blog

3 Ways to Increase Profitability and Compliance

October 1, 2013 by Drexel Rothrauff


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 and profitability.

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5 Reasons to Integrate Your CMMS with Your MES

April 26, 2012 by Jim Erickson


Over the past 5 years, many forward thinking companies have invested in Manufacturing Execution Systems (MES) to enable electronic Batch Records (Bio/Pharma industry) and Medical Device History Records (Medical Device industry). As these systems are built out, a logical integration point is between the MES and the CMMS. The desire for linking asset information usually maintained in your CMMS directly with the MES is compelling.

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Increased GMP Compliance Enforcement

January 8, 2012 by Jim Erickson


The recent Bio/Pharmaceutical Outsourcing Report article, FDA Increases Vigilance on Aseptic Processing Facilities does a good job describing the latest changes in the way the FDA is inspecting facilities.

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Top 5 GMP Asset Management Trends in 2012

January 4, 2012 by Jim Erickson


This time of year, it's hard not to make some predictions. There are certainly trends that will shape our lives in GMP asset management and our professional lives.

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What’s Driving the Resurgence in Paperless Systems?

November 4, 2011 by Jim Erickson


“Paperless” GMP calibration and maintenance systems became popular in the late 1990’s with the introduction of 21 CFR Part 11. Now, demand for even higher levels of productivity and compliance are driving the resurgence in paperless systems.

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