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Main Citation "Your firm failed to exercise appropriate controls over computer or related systems..." "The FDA identified a deficiency where the firm failed to perform a 'full audit trail review of production equipment.'" 15 "Lack of automated audit trails, allowing selective reporting of results." 16 Detailed Analysis of the Violation Production Equipment Audit Trails: The firm failed to perform a "full audit trail review of production equipment".15 In modern aseptic filling lines, the equipment is controlled by a Human Machine Interface (HMI) or Supervisory Control and Data Acquisition (SCADA) system

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