Warning Letter: Failure to validate computer software (ucm319510)

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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 a quality system, according to established procedure, as required by 21 C.F.R. 820.70(i). For example, there are no procedures that describe the qualification and maintenance of the Sorting software for decay calculations on brachytherapy seeds sorted into inventory. There are no software verification and validation requirements defined in your firm’s procedures, and there are no records documenting that the Sorting software is fully validated for its intended uses.

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