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 drug security threats and vulnerabilities in the supply chain.

These goals stem from the Drug Supply Chain Security Act (DSCSA) Title II of the Drug Quality and Security Act of 2013 in which the following [...] 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 government.

Regardless of whether a software program is developed by a company itself or is purchased off-the-shelf, it should have a defined objective before it is used for a specific [...] Read More