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How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by Zuhdi Hussein

You know which rules you're responsible for following, but is that enough?. [...] Read More

Posted in supplier audits

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by Henry Macartney

By default, your desire to market products in Europe makes EU cybersecurity. [...] Read More

Posted in governance techniques

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

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

Cloud Services Validation Creates Safer Operating Standards

April 9th, 2014 by Zuhdi Hussein

Although currently seldom used, cloud services are increasingly popular for. [...] Read More

Posted in Information Security Architecture Design

What Goes Into Quality Assurance For Medical Devices

February 20th, 2014 by James Francum

Quality assurance (QA) isn't something implemented solely for consumer. [...] Read More

Posted in Medical Device Quality Assurance

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