About: Title 21 CFR Part 11

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Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

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rdfs:label	Title 21 CFR Part 11 (en)
rdfs:comment	Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). (en)
dcterms:subject	United States federal law Code of Federal Regulations Regulation of medical devices Pharmaceuticals policy Pharmaceutical industry United States administrative law Food and Drug Administration Computer law Scientific documents Clinical data management
Wikipage page ID	7613634 (xsd:integer)
Wikipage revision ID	1105763716 (xsd:integer)
Link from a Wikipage to another Wikipage	Electronic lab notebook Electronic signature New Drug Application United States federal law Pharmaceutical company United States Computer system Electronic Signatures in Global and National Commerce Act Contract research organization Code of Federal Regulations Fax Regulation of medical devices Pharmaceuticals policy Food and Drug Administration (United States) Biologic medical product Medical device Electronic medical record HACCP Pharmaceutical industry United States administrative law Food and Drug Administration Computer law Biotechnology Scientific documents Code of Federal Regulations Audit trail Clinical data management Title 21 of the Code of Federal Regulations
Link from a Wikipage to an external page	https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm204012.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072322.pdf https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm125125.pdf http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm%3FCFRPart=11&showFR=1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm%3FCFRPart=11
sameAs	Title 21 CFR Part 11 Title 21 CFR Part 11 Title 21 CFR Part 11 Title 21 CFR Part 11 Title 21 CFR Part 11
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has abstract	Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). (en)
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prov:wasDerivedFrom	wikipedia-en:Title_21_CFR_Part_11?oldid=1105763716&ns=0
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is Link from a Wikipage to another Wikipage of	Electronic data capture Electronic lab notebook Electronic trial master file List of electronic laboratory notebook software packages Product lifecycle Electronic Signatures in Global and National Commerce Act Email archiving Laboratory information management system Clinical data acquisition Clinical data management Adobe Sign Outline of clinical research Dionex Predicate ARX (Algorithmic Research Ltd.) BioPharm (US company) DocuSign Title 21 of the Code of Federal Regulations Part 11 21 CFR 11 21 CFR Part 11 21cfr11
is Wikipage redirect of	Part 11 21 CFR 11 21 CFR Part 11 21cfr11
is foaf:primaryTopic of	wikipedia-en:Title_21_CFR_Part_11

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