Rules and Guidelines in 2013 for Computer System Validation

Annex 11 (“Computerised Systems”) and Chapter 4 of January 2011 have been revised in response to the increasing use of electronic documents within the GMP environment by the EMA (European Medicines Agency). Two years later (January 2013) we would like to reflect the current status of the implementation at some agencies and the pharmaceutical industry.

Download the article here: Computer System Validation 2013

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