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

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

    Correct Answer
    A. August 1997
    Explanation
    21 CFR Part 11 became effective in August 1997. This regulation was introduced by the U.S. Food and Drug Administration (FDA) to establish guidelines for the use of electronic records and electronic signatures in the pharmaceutical industry. It aimed to ensure the integrity, authenticity, and reliability of electronic records and signatures used in FDA-regulated activities. By setting these standards, the FDA sought to encourage the adoption of electronic systems while maintaining the same level of trust and reliability as paper-based systems.

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  • 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

    Correct Answer
    B. The people responsible for the content
    Explanation
    The correct answer is "The people responsible for the content." Under Part 11, the responsibility for controlling the content of a closed system lies with the individuals who are accountable for that content. This means that those who have the authority and ownership over the content are the ones who control it. The IT department may have a role in managing the technical aspects of the system, but the ultimate control over the content rests with the content owners. Users may have access to the system, but they do not have control over the content.

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  • 3. 

    Similarly, who controls the content of an open system?

    • A.

      People responsible for the content

    • B.

      The IT department

    • C.

      Nobody

    • D.

      Users

    Correct Answer
    C. Nobody
    Explanation
    In an open system, nobody controls the content. Open systems are designed to allow users to freely contribute and modify content without any central authority or control. This means that the responsibility for the content lies with the users themselves, who have the freedom to create and edit the content as they see fit. This decentralized approach ensures that no single entity has ultimate control over the content, promoting collaboration and inclusivity among users.

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  • 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

    Correct Answer
    D. All of the above
    Explanation
    21 CFR Part 11 is a regulation that sets forth the requirements for electronic records and electronic signatures in the pharmaceutical and healthcare industries. It requires the validation of computer systems to ensure their accuracy, reliability, and consistency. Additionally, it mandates controls for both open systems (systems that are accessible by multiple users) and closed systems (systems that are limited to a specific group of users). Therefore, the correct answer is "All of the above" as all these requirements are necessary to comply with 21 CFR Part 11.

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  • 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

    Correct Answer
    D. All of the above
    Explanation
    Signed electronic records shall contain information associated with the signing that clearly indicates the printed name of the signer, the date and time when the signature was executed, and the meaning associated with the signature. This ensures that there is a clear record of who signed the document, when it was signed, and the intention or purpose behind the signature. Including all of this information provides a comprehensive and reliable record of the signing process.

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  • 6. 

    Controls for closed systems require which of the following

    • A.

      Validation of systems

    • B.

      Electronic signatures

    • C.

      There are no controls

    • D.

      BIometrics

    Correct Answer
    A. Validation of systems
    Explanation
    Validation of systems is required for closed systems because it ensures that the system is functioning correctly and meets the intended requirements. This process involves testing and verifying the system's components, operations, and performance to ensure that it operates reliably and securely. Validation helps to identify and mitigate any potential risks or vulnerabilities in the system, ensuring that it can be trusted for its intended purpose. Without validation, there is no assurance that the system will function as intended and meet the necessary control requirements.

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  • 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

    Correct Answer
    B. Internet
    Explanation
    An example of an open system is the Internet. The Internet is a global network that allows communication and information sharing between different devices and networks. It is accessible to anyone and allows for the exchange of data, resources, and services. It is not limited to a specific organization or network, making it an open system.

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  • 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

    Correct Answer
    D. B and c
    Explanation
    The correct answer is "b and c" because both the intranet and the learning management system (LMS) on the intranet are examples of closed systems. A closed system is a computer network or software that is only accessible to authorized users within a specific organization or group. The internet, on the other hand, is an example of an open system as it is accessible to anyone with an internet connection. Therefore, options b and c are the only ones that fit the definition of a closed system.

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  • 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

    Correct Answer
    D. Both a and c
    Explanation
    Those who develop, maintain or use electronic records/electronic signature systems require education and training to perform their assigned tasks. Education provides them with the necessary knowledge and understanding of electronic records and signature systems, while training equips them with the practical skills and techniques needed to effectively utilize these systems. By having both education and training, individuals can confidently and efficiently carry out their responsibilities in relation to electronic records and signature systems.

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  • 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

    Correct Answer
    B. Document encryption
    Explanation
    Additional measures to be considered for open systems include document encryption. This is because open systems are more vulnerable to security threats and unauthorized access. Document encryption ensures that sensitive information is protected by converting it into a code that can only be deciphered with a specific key or password. This helps to prevent unauthorized individuals from accessing or tampering with the documents. By implementing document encryption, organizations can enhance the security of their open systems and protect sensitive information from potential breaches.

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  • Current Version
  • Mar 21, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Mar 26, 2013
    Quiz Created by
    Agnesshanley
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