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Compliance Glossary

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Entries 1 to 5 of 5

F:
FDA 21 CFR Part 11
FDA 21 CFR Part 120
FDA 21 CFR Part 820 / Quality System Regulations
FDA 21 CFR Part 820 / Quality System Regulations
FMEA - Failure mode effects analysis
 
FDA 21 CFR Part 11
The FDA’s rule that defines the criteria under which electronic records and signatures are acceptable, i.e. equivalent to paper records.