CSV FDA Warning Letters : Security / Audit Trail

Date: 12 August 2008
Link: FDA Warning Letter (New Window)

Observation6. Failure to establish appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel as required by 21 CFR 211.68 (b).
For example, the [redacted] data acquisition system for the [redacted] UV/Visible