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21 CFR Part 11 : When ?
21CFRpart11 is a regulation issued in 1997 by US FDA which identifies a number of requirements related to computer systems, electronic data, electronic signatures and their supporting documentation.
21 CFR Part 11 : Why ?
21 CFR part 11 was rolled out aiming at making paper records and handwritten signatures equivalent to electronic records and electronic signatures.
21 CFR Part 11 : Objectives ?
The key objectives of 21 CFR part 11 regulations:
Retention/documentation of records
Integrity/security of Records
FDA Access to Records
Authentication of Electronic Signatures
Accountability for Maintaining Records System
Validation
The tree :
CFR > 21 Food and Drugs > CHAPTER I > 11 Electronic records; electronic signatures (among some 1316 parts)
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Section Contents
Subpart A—General Provisions
§ 11.1 Scope.
§ 11.2 Implementation.
§ 11.3 Definitions.
Subpart B—Electronic Records
§ 11.10 Controls for closed systems.
§ 11.30 Controls for open systems.
§ 11.50 Signature manifestations.
§ 11.70 Signature/record linking.
Subpart C—Electronic Signatures
§ 11.100 General requirements.
§ 11.200 Electronic signature components and controls.
§ 11.300 Controls for identification codes/passwords.
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What is CFR :
CFR is Code of federal regulations (United states of America). It is divided into 50 titles.
CFR Titles :
Title 1 General Provisions
Title 2 [Reserved]
Title 3 The President
Title 4 Accounts
Title 5 Administrative Personnel
Title 6 Homeland Security
Title 7 Agriculture
Title 8 Aliens and Nationality
Title 9 Animals and Animal Products
Title 10 Energy
Title 11 Federal Elections
Title 12 Banks and Banking
Title 13 Business Credit and Assistance
Title 14 Aeronautics and Space
Title 15 Commerce and Foreign Trade
Title 16 Commercial Practices
Title 17 Commodity and Securities Exchanges
Title 18 Conservation of Power and Water Resources
Title 19 Customs Duties
Title 20 Employees' Benefits
Title 21 Food and Drugs
Title 22 Foreign Relations
Title 23 Highways
Title 24 Housing and Urban Development
Title 25 Indians
Title 26 Internal Revenue
Title 27 Alcohol, Tobacco Products and Firearms
Title 28 Judicial Administration
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Title 30 Mineral Resources
Title 31 Money and Finance: Treasury
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Title 34 Education
Title 35 Panama Canal
Title 36 Parks, Forests, and Public Property
Title 37 Patents, Trademarks, and Copyrights
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Title 39 Postal Service
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Title 42 Public Health
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Title 44 Emergency Management and Assistance
Title 45 Public Welfare
Title 46 Shipping
Title 47 Telecommunication
Title 48 Federal Acquisition Regulations System
Title 49 Transportation
Title 50 Wildlife and Fisheries
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