EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant systems (GMP Computerised Systems) and their GMP functionality (inventory).
This is also a Japanese regulatory requirement and also an expectation of the FDA although not included within the
Wednesday, 7 December 2011
EU Annex 11 - Computer System Inventory
Posted on 10:36 by Unknown
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