Guideline: Part 11, Electronic Records, Electronic Signatures: Scope and Application
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| Titel: | Part 11, Electronic Records, Electronic Signatures: Scope and Application |
| Internet: | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070295.pdf |
| Herkunft/Verlag: | FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857 |
| Inhalt: | FDA Interpretation zum Zweck und Inhalt des Part 11 |
| Status: | final |
| Dokumentenart: | FDA Draft Guidance |