Warning Letter: Failure to validate computer software (ucm377097)


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: Document No. IN-26_01_002, No. 1, dated March 25, 2013, Validierungsmasterplan [Validation Master Plan] developed as part of CAPA 2335, states that [redacted], [redacted], and [redacted], are software programs that are considered critical, which requires software validation. These programs have not been validated by your firm.”

View the original warning letter.


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