February 17, 2006
Recipient: National Genetics Institute.Product:HIV-1 and Hepatitis C virus nucleic acid tests Date: 1/17/2006 FDA District:Los Angeles District Office Failure to validate computer software used in production; failure to validate the quality system; failure to document validation activities and results; failure to make adequate provisions for monitoring laboratory test procedures and instruments; failure to maintain written...
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John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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