FDA CDER Part 11 Assessment Initiative

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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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