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How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re responsible for following, but is that enough? Agencies like the FDA rarely make exceptions for firms that misinterpret the law, and although you may be able [...] Read More

Deciphering EU Cybersecurity Plans and Policies

March 25th, 2015 by

Cyber SecurityBy default, your desire to market products in Europe makes EU cybersecurity compliance one of your primary organizational goals. Unfortunately, the path to effective regulatory adherence [...] Read More

Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by

CAPA Root Cause AnalysisCAPAs, or Corrective and Preventive Actions, are largely designed to help GxP-regulated firms handle non-conformity problems. In order to deal with undesirable occurrences in manufacturing processes, [...] Read More

Harmonization Processes Through ICH  

September 3rd, 2014 by

ICH Harmonization ProcessThe methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively [...] Read More

Cloud Services Validation Creates Safer Operating Standards

April 9th, 2014 by

Cloud Services ValidationAlthough currently seldom used, cloud services are increasingly popular for life sciences firms that want to keep up with their competition. These firms use distributed computing architectures to [...] Read More

What Goes Into Quality Assurance For Medical Devices

February 20th, 2014 by

Medical Device Quality AssuranceQuality assurance (QA) isn’t something implemented solely for consumer satisfaction. In most industries, including that of medical device manufacturing, your QA efforts have very real effects on your ability to legally conduct business in the United States, EU and other global locations.

In some cases, meeting quality management regulations may be more difficult using only in-house resources. Learn how [...] Read More