CFR Regulatory Requirements Quiz

10 Questions | By Complianceon1 | Last updated: Oct 18, 2022 | Total Attempts: 1346

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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
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
3.

Creation, modification, and deletion of electronic records should be recorded in audit trails.
- A.
  
  True
- B.
  
  False
4.

Audit trails should only record the modification of electronic records.
- A.
  
  True
- B.
  
  False
5.

Objects that are signed by electronic signatures should display just the signed name and date.
- A.
  
  True
- B.
  
  False
6.

Only the signed name and date are required on objects that have been signed by electronic signatures.
- A.
  
  True
- B.
  
  False
7.

Signed objects can be edited after they have been signed.
- A.
  
  True
- B.
  
  False
8.

Electronic signatures are not digital signatures.
- A.
  
  True
- B.
  
  False
9.

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