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  • Warning Letter: Failure to Validate Spreadsheets (ucm185865)

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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, when requested, no validation information or protocols were provided for the [redacted] software which is used for product complaints, CAPA requests/actions, preventive action request/actions, and creating quality logs.

    View the original warning letter.


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