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Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by James Francum

CAPAs, or Corrective and Preventive Actions, are largely designed to help. [...] Read More

Posted in Root Cause Analysis

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by Zuhdi Hussein

Regulatory compliance is important for any life-sciences firm, but the breadth. [...] Read More

Posted in GxP CC

What Goes into CSV Compliance?  

September 5th, 2014 by Henry Macartney

Most of the more complex computer systems employed by life-sciences firms are. [...] Read More

Posted in GxP CC

Harmonization Processes Through ICH  

September 3rd, 2014 by James Francum

The methodologies your firm employs in the creation of pharmaceuticals,. [...] Read More

Posted in Quality Risk Management System

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