Warning Letter: Failure to validate computer software for its intended use according to an established protocol (ucm515647)

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Ofni Systems

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 has not validated the software, [redacted], used to manage various activities such as complaints, CAPAs, repairs, servicing, internal and external audits, and warranty service. Your firm has been utilizing this software since January 2011

 

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