21 CFR Part 11 Regulatory Requirements Quiz

8 Questions | Total Attempts: 1058

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21 CFR Part 11 Regulatory Requirements Quiz

How well do you know 21 CFR Part 11 compliance requirements? Take our quiz to find out! Please provide your official email id and name so these can be included in the certificate at the end of the quiz.


Questions and Answers
  • 1. 
    True or False: Part 11 allows any predicate rule that calls for a signature to be satisfied with an electronic signature.
    • A. 

      True

    • B. 

      False

  • 2. 
    True or False: 21 CFR Part 11 does not apply to electronic records submitted to the FDA under the FD&C Act and the Public Health Service Act.
    • A. 

      True

    • B. 

      False

  • 3. 
    According to 21 CFR Part 11, a “Closed System” means:
    • A. 

      A system that is stored in a space that is physically secured by lock and key or passwords

    • B. 

      An environment where system access is controlled by system administrators

    • C. 

      A system that cannot be altered or modified in any way

    • D. 

      A system that can be accessed by only one worker in the organization

  • 4. 
    Audit trails should only record the modification of electronic records
    • A. 

      Yes - only modifications to electronic records should be recorded in audit trails

    • B. 

      No - creation, modification and deletion of electronic records should be recorded in audit trails

  • 5. 
    Objects that are signed by electronic signatures should display just the signed name and date.
    • A. 

      Yes – only the signed name and date is required on objects that have been signed by electronic signatures

    • B. 

      No – the objects signed by electronic signatures should display signed name, date, time and meaning of the signature

  • 6. 
    True or False: Signed objects can be edited after they have been signed.
    • A. 

      True

    • B. 

      False

  • 7. 
    True or False: Electronic signatures are not digital signatures
    • A. 

      True

    • B. 

      False

  • 8. 
    The best date format to use on electronic records is:
    • A. 

      DD/MM/YY (10/01/03)

    • B. 

      DD-MM-YYYY (10-01-2003)

    • C. 

      MM/DD/YYYY (01/10/2003)

    • D. 

      DD-MMM-YYYY(10-JAN-2003)

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