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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Part 11, Electronic Records, Electronic Signatures: Scope and Application |
| Internet: | http://www.fda.gov/cder/guidance/5667fnl.pdf |
| Origin/Publisher: | FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857 |
| Content: | This guidance is intended to describe the FDA's current thinking regarding the scope and application of PArt 11 |
| Document Type: | FDA Draft guidance |
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