Warning Letter: Failure to provide validation documentation (ucm293443)

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Ofni Systems

Failure to validate computer software used as a part of production or the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm could not provide any documentation to demonstrate that the software used for the 6111 PCB (Printed Circuit Board) check machine [redacted] was validated for its intended use. Your firm’s Department Manager of Regulatory Affairs stated that the software used for the PCB check machine has not been validated.

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