Warning Letter: Hospital stretcher manufacturer failed to validate computer software (ucm 355751)

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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). Specifically, [redacted], developed by [redacted], is used to transfer and make changes to drawings used to manufacture devices. There is no protocol or documentation demonstrating that this software has been validated for its intended use.

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