Title 21 CFR Part 11 : Trivia Questions On FDA Guidance For Industry! Quiz

10 Questions | Total Attempts: 444

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Title 21 CFR Part 11 : Trivia Questions On FDA Guidance For Industry! Quiz

Welcome to Title 21 CFR part 11 trivia questions on FDA guidance for industry! This code is designed to cover digital signatures and, generally, extend its oversight to IT, software and the digital world. The code has been widely misunderstood, and some say, misapplied by pharma companies. Take the quiz and see if you are in the list of people who understand the code.


Questions and Answers
  • 1. 
    When did 21 CFR Part 11 become effective?
    • A. 

      August 1997

    • B. 

      March 1997

    • C. 

      April 2001

    • D. 

      January 1999

  • 2. 
    Under Part 11, who controls the content of a closed system?
    • A. 

      The IT department

    • B. 

      The people responsible for the content

    • C. 

      Users

    • D. 

      Nobody

  • 3. 
    Similarly, who controls the content of an open system?
    • A. 

      People responsible for the content

    • B. 

      The IT department

    • C. 

      Nobody

    • D. 

      Users

  • 4. 
    21 CFR Part 11 requires which of the following?
    • A. 

      Validation of computer systems

    • B. 

      Controls for open systems

    • C. 

      Controls for closed systems

    • D. 

      All of the above

  • 5. 
    Signed electronic records shall contain information associated with the signing that clearly indicates which of the following?
    • A. 

      The printed name of the signer

    • B. 

      The date and time when the signature was executed

    • C. 

      The meaning (such as review, approval, responsibility or authorship) associated with the signature

    • D. 

      All of the above

  • 6. 
    Controls for closed systems require which of the following
    • A. 

      Validation of systems

    • B. 

      Electronic signatures

    • C. 

      There are no controls

    • D. 

      BIometrics

  • 7. 
    An example of an open system is which of the following?
    • A. 

      ERP system on the Intranet

    • B. 

      Internet

    • C. 

      Intranet

    • D. 

      QMS on the Intranet

  • 8. 
    Which of the following is an example of a closed system?
    • A. 

      Internet

    • B. 

      Intranet

    • C. 

      LMS on the Intranet

    • D. 

      B and c

  • 9. 
    Those who develop, maintain or use electronic records/electronic signature systems require which of the following to perform their assigned tasks?
    • A. 

      Education

    • B. 

      An electronic signature

    • C. 

      Training

    • D. 

      Both a and c

  • 10. 
    Additional measures to be considered for open systems include which of the following?
    • A. 

      Biometrics

    • B. 

      Document encryption

    • C. 

      Electronic signatures

    • D. 

      There are no additional measures to be conducted