Warning Letter: Failure to adequately validate software (ucm399011)

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Ofni Systems

Failure to adequately validate software used as part of production and the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i). Specifically, actions were not taken to ensure that computer errors would not result in the loss of dosimetry and run dose data from the Dosimetry Measurement Application (DMA) module of [redacted].

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