validate computer software

Warning Letter: Failure to validate computer software (ucm538430)

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Failure to ensure that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm’s [redacted] software has not been validated for its intended use. This software is used for documentation and tracking of product design and design change projects, as well as for quality related activities such as complaints, corrective and preventive actions and nonconformances.

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