Warning Letter: Failure to validate software (ucm465665)

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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).

For example, your firm uses the software [redacted], developed by [redacted], to document, maintain, and track customer complaints electronically. However, as stated by your firm’s Director of Quality Assurance (QA) & Regulatory Affairs (RA) during the inspection, the software does not generate time-stamped audit trails to independently record the date and time of operator entries and actions that create, edit, or modify electronic records.”

View the original warning letter.


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