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Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b))." 4 "During the review of analytical system audit trails for final release testing of finished OTC drug products, our inspection found that your firm does not review audit trails and raw analytical data captured by these analytical instruments
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Heart Rhythm, 14 (12), 18491855
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