There have been many changes to the approach to validation of equipment, including computerised systems over the last few years. This has culminated in the release of GAMP 5 in 2008.
The changes in approach started with the publication of the ICH Q9 (Quality Risk Management) in 2005 and adopted by the major agencies. This presented a risk based approach to quality management including validation
Tuesday, 11 May 2010
Changes in validation
Posted on 06:24 by Unknown
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