CFR Regulatory Requirements Quiz

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| By Complianceon1

Complianceon1

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Quizzes Created: 7 | Total Attempts: 6,125

Questions: 10 | Attempts: 1,446 | Updated: Aug 31, 2023

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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.

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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.

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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.

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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.

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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.

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1
0
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.

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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.

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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.

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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.

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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.

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Current Version
Aug 31, 2023

Quiz Edited by
ProProfs Editorial Team
Aug 02, 2013

Quiz Created by
Complianceon1

CFR Regulatory Requirements Quiz

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

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.

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

Audit trails should only record the modification of electronic records.

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

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

Signed objects can be edited after they have been signed.

Electronic signatures are not digital signatures.

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

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