Warning Letter: Failure to validate software (ucm185261)

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Ofni Systems

Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 CFR § 820.70(i). For example, the [redacted] and [redacted] software used to generate instruction manuals, clinician’s manuals and prescription device labels for the [redacted] devices has not been validated.

View the original warning letter.


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