Warning Letter: Failure to exercise appropriate controls (ucm253467)

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Ofni Systems

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 authorized personnel [21 C.F.R § 211.68(b)]. For example, your firm lacks control of the [redacted] computer system which monitors equipment, room differential pressure, room humidity, and stability chambers. Although the system is password protected for temperature and humidity set points, all employees have access to the room where the [redacted] computer system is located and the external hard drive is not password protected. During the inspection we observed that an employee was able to alter or delete data without a password and save the changed file.

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