Warning Letter: No software validation (ucm330805)

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Ofni Systems

Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include requirements for (1) analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary; (2) investigating the cause of nonconformities; (3) identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems; (4) verifying and validating corrective and preventive actions to ensure that the actions do not adversely affect the products; (5) implementing and recording changes necessary to correct and prevent identified quality problems; and (6) disseminating information related to quality problems and nonconforming product, as required by 21 CFR 820.100(a).
For example, review of three out of [redacted] Corrective and Preventive Action (CAPA) records revealed:

a) Q-case #[redacted] concerned [redacted]. Your firm’s investigation identified and processed the corrective actions as a production nonconformance, but statistical methods were not used to quantify the problem. The corrective action of [redacted] was implemented, but validation was not conducted or documented to ensure that the corrective actions was effective and did not adversely affect the product.

View the original warning letter.


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