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21 CFR PART 11 - Coggle Diagram
21 CFR PART 11
Subpart B: Electronic Records
11.30 Controls for open systems
11.10
Document encryption & Digital signature standards
11.50 Signature manifestations
a. name, time stamp, meaning
b. all controls as above
11.10 Controls for closed systems
k) System documentation
j. Policies for signatures
i. Determination of persons and education
h. Device checks
g. Authority checks
f. Operational system checks
e. Audit trails
d. Limiting system access
c. Protection of records
b. Human readable records
a. Validation
11.70 Signature/Record linking
Subpart A: General Provisions :
11.2 Implementation
11.3 Definitions
11.1 Scope
Subpart C: Electronic Signatures
11.200 Electronic signature components & controls
b. Biometrics
q. Uniqueness of code/password
11.300 Controls for identification codes/passwords
a. uniqueness of the code/password
b. periodic check of issuance
c. loss management
d. Safeguards and detection of unauthorized attempts
e. Initial and periodic testing
11.100 General Requirements
b. Verification of identity
a. Uniqueness to individual
c. Certification of equivalence