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Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by

IT Infrastructure Qualification Strategies[...] Read More

Are You Up To Speed On The FDA’s New Regulation On Supply Chain Integrity

May 16th, 2014 by

FDA Supply Chain IntegrityThe Division of the Supply Chain Integrity of the FDA has two main goals, which are:

  1. Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers.
  2. Raising public awareness of [...] Read More

How to Ensure CSV Compliance For Your Software

January 27th, 2014 by

CSV ValidationCSV (Computer System Validation) compliance is something that the FDA and the European Regulatory Authorities take very seriously. Software programs that are not in compliance with validation and the associated infrastructure qualification measures could result in a product recall by the [...] Read More