Day

October 14, 2010
At the October AAMI Software Validation Course the FDA instructor indicated that the device center is not participating in this and that the Drug center’s intent is to gather information on how companies handle electronic records and signatures and not to ramp up enforcement of Part 11.
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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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