Recipient:Biochem Laboratories Inc. Product:TX1 Tissue Removal System Date: 2/17/2012 Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: a. Your firm did not put in place requirements...Read More
Schedule Discussion with John F. Murray, Jr.
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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