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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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| Guidance for Industry 21 CFR Part 11, Electronic Records, Electronic Signatures: Validation |
| Short Title: | 21 CFR Part 11 Validation |
| Internet: | http://www.fda.gov/OHRMS/DOCKETS/98fr/001538gd.pdf |
| Origin/Publisher: | FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857 |
| Content: | This Guidance for Industry describes FDA's current thinking about how the validation requirements of 21 CFR Part 11 Electronic Records, Electronic Signatures can be realised. |
| Status: | withdrawn |
| Document Type: | FDA Guidance for Industry |
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