Warning Letter: Failure to validate computer software (ucm399519)

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Ofni Systems

Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, during the inspection your firm confirmed that its software program [redacted] version [redacted] released on August 28, 2009, for documenting condom production control tests has not been validated for its intended uses.

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