As stated in the earlier post EU Annex 11 has been updated and becomes effective on the 30 June 2011. This is part of a series of reviews detailing what has changed and the impact on Computer Systems Validation.
Risk Management now underpins the whole process of Computer Systems Validation. This has been a driving force since the introduction of GAMP4 and even more so through GAMP5.
In the
Wednesday, 23 February 2011
EU Annex 11 – Risk Management
Posted on 10:02 by Unknown
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