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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

Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by

Process ValidationHow do you know your life sciences firm is maintaining compliance? While FDA audits and warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they’ll continue to do so [...] 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