EU Annex 11 - Electronic Signatures

Electronic Signatures
This is a continuation of a review of the update to EU Annex 11 and Chapter 4 (Documentation) that was issued in January 2011 to become effective on the 30 June 2011.

As stated in the previous article the EU Annex 11 update does not directly reference Electronic Records this is included in the update to EU Chapter 4 (Documentation).

The update to EU Annex 11 however does

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CSV FDA Warning Letters : Electronic Records

Date: 28 Jan 11
Link: FDA Warning Letter (New Window)
ObservationIn addition, we remain concerned that your (b)(4) adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts. The current application was released into production on November 9, 2009 using an Interim Validation report (IVR) that is

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CSV FDA Warning Letters : Laboratory Systems Security

Date: 20 April 2010
Link: FDA Warning Letter (New Window)
ObservationThis is a follow up letter from an inspection in 2009 where the security of laboratory systems had been raised within the FDA 483.

6. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by

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