Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by

IT Infrastructure Qualification Strategies[...] Read More

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by

FDA Cloud Computing ValidationAdopting cloud-based technologies is a common step for [...] Read More

Getting to Know FDA Software Validation Principles

October 3rd, 2014 by

FDA Software ValidationHow can your firm validate its software effectively when it’s such an integral part of everything you do? Today’s GxP-regulated organizations employ software for stock tracking, supply chain [...] Read More

What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the more complex computer systems employed by life-sciences firms are in some way customized. Even those who rely on vendor-assembled systems often find themselves having to tweak [...] 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