FDA Guidance for Industry: Part 11, Electronic Records, Electronic Signatures: Scope and Application

Title:
FDA Guidance for Industry: Part 11, Electronic Records, Electronic Signatures: Scope and Application

https://www.gmp-compliance.org/files/guidemgr/5667fnl.pdf

Origin/Publisher:

FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857

Document Type:
FDA Draft guidance
Content:
This guidance is intended to describe the FDA's current thinking regarding the scope and application of PArt 11

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