April 24, 2007
RecipientG&B Electronic Designs Limited Product: Tracklt and NicoletOne Ambulatory Electroencephalograph Recorder devices Date:4/24/2007 Failure to assure that when computers or automated data processing systems are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i)....
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