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Clear Blue Blog

Compliance Series 5: Core EAM/CMMS Functionality for Compliance

March 10, 2015 by Jim Erickson

Purpose-built GMP asset management systems, such as Blue Mountain RAM, come with out of the box functionality that provide immediate benefits. In terms of compliance and the FDA, it is vital that your EAM/CMMS was built to support electronic signatures (21 CFR Part 11) (which will aid in going paperless down the road) and an audit trail of all changes made to an asset, work order, or another record stored in the EAM.


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

March 5, 2015 by Jim Erickson

Now that we’ve covered broader GMP issues in the previous 3 blogs, I want to shift by discussing 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 functionality and needs for Maintenance, Calibration and Validation.


Compliance Series 2: Focus on Quality Not Compliance

January 26, 2015 by Jim Erickson

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 quality treatments.


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.


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.


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.


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.


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.