Title 21, Code of Federal Regulations, Part 11. Part 11 established the criteria under which electronic records and signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes regulated by the FDA. See Code of Federal Regulations.
Glossary
21 CFR Part 11
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Ampoule (Ampule)
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HME
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Validation
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APIs
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Toxicology
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GDUFA
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Inspections
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Capsules
Microcapsule
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Wurster Process
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