Warning Letter: Failure to validate computer software (s6643c)

Tags:

Ofni Systems
 
"5. Failure to adequately
validate computer software
used in an automated process for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, no person from your firm reviewed or approved the third party approval test resultsfor the original " [redacted]
Complaint System Validation
" used in your firm's quality system."

View the original warning letter.


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