CFR Regulatory Requirements Quiz

Approved & Edited by ProProfs Editorial Team
The editorial team at ProProfs Quizzes consists of a select group of subject experts, trivia writers, and quiz masters who have authored over 10,000 quizzes taken by more than 100 million users. This team includes our in-house seasoned quiz moderators and subject matter experts. Our editorial experts, spread across the world, are rigorously trained using our comprehensive guidelines to ensure that you receive the highest quality quizzes.
Learn about Our Editorial Process
| By Complianceon1
C
Complianceon1
Community Contributor
Quizzes Created: 7 | Total Attempts: 5,974
Questions: 10 | Attempts: 1,412

SettingsSettingsSettings
CFR Regulatory Requirements Quiz - Quiz

How well do you know 21 CFR Part 11 compliance requirements? Take our CFR regulatory requirements quiz to find out! The Code of Federal Regulations, also known as CFR, is a compilation of mandatory laws that are created by several federal regulatory agencies. An example of those regulatory agencies is OSHA, which is one of the most familiar organizations to the workforce. Here are some interesting questions for your practice. Let's go!


Questions and Answers
  • 1. 

    Part 11 allows any predicate rule that calls for a signature to be satisfied with an electronic signature.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    Part 11 allows any predicate rule that calls for a signature to be satisfied with an electronic signature. This means that electronic signatures are considered valid and acceptable for fulfilling the requirements of a signature in Part 11.

    Rate this question:

  • 2. 

    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

    Correct Answer
    B. False
    Explanation
    21 CFR Part 11 applies to electronic records submitted to the FDA under the FD&C Act and the Public Health Service Act.

    Rate this question:

  • 3. 

    Creation, modification, and deletion of electronic records should be recorded in audit trails.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    Audit trails are an essential component of electronic record management systems. They provide a detailed record of all activities related to the creation, modification, and deletion of electronic records. By recording these actions, audit trails ensure accountability and transparency, allowing organizations to track and investigate any unauthorized or suspicious activities. They also help in maintaining the integrity and reliability of electronic records by providing a complete history of changes made to them. Therefore, it is important to record the creation, modification, and deletion of electronic records in audit trails.

    Rate this question:

  • 4. 

    Audit trails should only record the modification of electronic records.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    Audit trails should not only record the modification of electronic records but also capture any access, creation, or deletion of electronic records. This helps in maintaining a comprehensive record of all activities related to electronic records, ensuring accountability and traceability. Therefore, the statement that audit trails should only record the modification of electronic records is incorrect.

    Rate this question:

  • 5. 

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

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The statement is false because objects that are signed by electronic signatures should not only display the signed name and date, but also other relevant information such as the method of signature, the certificate used, and any applicable timestamps. The purpose of electronic signatures is to provide a secure and legally binding way to authenticate electronic documents, and simply displaying the signed name and date would not fulfill this purpose.

    Rate this question:

  • 6. 

    Only the signed name and date are required on objects that have been signed by electronic signatures.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    The statement is incorrect. Objects that have been signed by electronic signatures require more than just the signed name and date. Additional information such as the signer's identity, the method of signing, and any applicable certifications or timestamps may also be required. Therefore, the correct answer is false.

    Rate this question:

  • 7. 

    Signed objects can be edited after they have been signed.

    • A.

      True

    • B.

      False

    Correct Answer
    B. False
    Explanation
    Signed objects cannot be edited after they have been signed. When an object is signed, it means that it has been verified and its integrity has been ensured. Any modification to the signed object would invalidate the signature and raise concerns about its authenticity. Therefore, the statement that signed objects can be edited after being signed is false.

    Rate this question:

  • 8. 

    Electronic signatures are not digital signatures.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    Electronic signatures and digital signatures are two different concepts. An electronic signature refers to any electronic process that indicates the signer's intent to be bound by the contents of a document. It can be as simple as typing a name or using a stylus on a touch screen. On the other hand, a digital signature is a specific type of electronic signature that uses cryptographic technology to verify the authenticity and integrity of a document. Therefore, it is correct to say that electronic signatures are not digital signatures.

    Rate this question:

  • 9. 

    The best date format to use on electronic records is DD-MMM-YYYY(10-JAN-2003).

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    The DD-MMM-YYYY format, such as 10-JAN-2003, is considered the best date format for electronic records. This format is easily understandable and universally recognized, reducing the chances of misinterpretation or confusion. It follows a consistent order of day, month, and year, which is helpful for sorting and organizing data. Additionally, using three-letter abbreviations for months eliminates any ambiguity that may arise from different date formats used in different regions. Overall, the DD-MMM-YYYY format ensures clarity, accuracy, and ease of use for electronic records.

    Rate this question:

  • 10. 

    According to 21 CFR Part 11, a “Closed System” means an environment where system access is controlled by system administrators.

    • A.

      True

    • B.

      False

    Correct Answer
    A. True
    Explanation
    According to 21 CFR Part 11, a "Closed System" refers to an environment where system access is regulated and controlled by system administrators. This means that only authorized individuals have the ability to access and make changes to the system. Therefore, the statement "True" accurately reflects the definition of a closed system as per the regulation.

    Rate this question:

Related Topics

Back to Top Back to top
Advertisement
×

Wait!
Here's an interesting quiz for you.

We have other quizzes matching your interest.