This is a continuation of a review of the update to EU Annex 11 and Chapter 4 (Documentation) that issued in January 2011 to become effective on the 30 June 2011.
Electronic Records have for so long only taken guidance from the FDA, however it has always been an expectation of the MHRA / EU that electronic records, including raw data must have the same integrity as paper records.
EU Annex 11
Monday, 28 February 2011
EU Annex 11 – Electronic Records
Posted on 10:10 by Unknown
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