New EU Annex 11 [Regulatives / Guidelines]

posted by jlanteigne – 2011-03-03 22:03 (5598 d 08:26 ago) – Posting: # 6701
Views: 1,679
(edited on 2011-03-03 23:48)

Dear all,

I'm wondering if the EU GMP Annex 11 concerning computerised systems applies to GLP and GCP studies such as 21 CFR part 11?

Regards

Johanne

Edit: document linked [Ohlbe]

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