Created by

Keerthana Premkumar

India


Froggy Jumps 21 CFR Part 11 QuizOnline version Test your knowledge about 21 CFR Part 11, a regulation that establishes the criteria for electronic records and signatures in the pharmaceutical industry. by Keerthana Premkumar 1 What does 21 CFR Part 11 regulate? a Electronic records and signatures b Clinical trial protocols c Pharmaceutical manufacturing processes 2 What industry does 21 CFR Part 11 apply to? a Automotive b Food and beverage c Pharmaceutical 3 What is the purpose of 21 CFR Part 11? a To reduce manufacturing costs b To expedite the approval process for new drugs c To ensure the authenticity, integrity, and reliability of electronic records and signatures 4 What is an electronic signature? a A digital representation of a person's intent to sign b A handwritten signature on a printed document c A stamp or seal 5 What is the scope of 21 CFR Part 11? a Only electronic signatures on drug labels b All electronic records and signatures that are required by FDA regulations c Only electronic records stored in the cloud 6 What are the key requirements of 21 CFR Part 11? a Product labeling, packaging, and shipping b Validation, audit trails, access controls, and electronic signatures c Employee training and development 7 It is an environment in which system access cannot be controlled by persons who are responsible for the content of electronic records that are on the system. a Open Systems b Closed Systems c Computerized system 8 What is the penalty for non-compliance with 21 CFR Part 11? a Temporary suspension of business operations b Warning letters, fines, and product recalls c Verbal reprimand 9 An electronic signature based upon cryptographic methods of origination, authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified a Electronic Signature b Hand-written Signature c Digital Signature 10 What is the role of an electronic record in 21 CFR Part 11? a To supplement paper records b To be used in parallel with paper records c To replace paper records 11 It is an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. a Closed System b Open System c Digital Signatures 12 Additional measures to be considered for open systems include which of the following? a Biometrics b Document encryption c Electronic signatures 13 What is the purpose of validation in 21 CFR Part 11? a To verify the accuracy of electronic signatures b To prevent unauthorized access to electronic records c To ensure that electronic systems perform as intended 14 What is the FDA's role in enforcing 21 CFR Part 11? a To conduct inspections and audits b To develop new regulations c To provide training and guidance 15 This is a method of verifying an individual's identity based on measurement of the individual's physical feature or repeatable action where those features and/or actions are both unique to that individual and measurable. a Digital Signature b Biometrics c Credentials

Froggy Jumps

21 CFR Part 11 QuizOnline version

Test your knowledge about 21 CFR Part 11, a regulation that establishes the criteria for electronic records and signatures in the pharmaceutical industry.

by Keerthana Premkumar

What does 21 CFR Part 11 regulate?

Electronic records and signatures

Clinical trial protocols

Pharmaceutical manufacturing processes

What industry does 21 CFR Part 11 apply to?

Automotive

Food and beverage

Pharmaceutical

What is the purpose of 21 CFR Part 11?

To reduce manufacturing costs

To expedite the approval process for new drugs

To ensure the authenticity, integrity, and reliability of electronic records and signatures

What is an electronic signature?

A digital representation of a person's intent to sign

A handwritten signature on a printed document

A stamp or seal

What is the scope of 21 CFR Part 11?

Only electronic signatures on drug labels

All electronic records and signatures that are required by FDA regulations

Only electronic records stored in the cloud

What are the key requirements of 21 CFR Part 11?

Product labeling, packaging, and shipping

Validation, audit trails, access controls, and electronic signatures

Employee training and development

It is an environment in which system access cannot be controlled by persons who are responsible for the content of electronic records that are on the system.

Open Systems

Closed Systems

Computerized system

What is the penalty for non-compliance with 21 CFR Part 11?

Temporary suspension of business operations

Warning letters, fines, and product recalls

Verbal reprimand

An electronic signature based upon cryptographic methods of origination, authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified

Electronic Signature

Hand-written Signature

Digital Signature

What is the role of an electronic record in 21 CFR Part 11?

To supplement paper records

To be used in parallel with paper records

To replace paper records

It is an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Closed System

Open System

Digital Signatures

Additional measures to be considered for open systems include which of the following?

Biometrics

Document encryption

Electronic signatures

What is the purpose of validation in 21 CFR Part 11?

To verify the accuracy of electronic signatures

To prevent unauthorized access to electronic records

To ensure that electronic systems perform as intended

What is the FDA's role in enforcing 21 CFR Part 11?

To conduct inspections and audits

To develop new regulations

To provide training and guidance

This is a method of verifying an individual's identity based on measurement of the individual's physical feature or repeatable action where those features and/or actions are both unique to that individual and measurable.

Digital Signature

Biometrics

Credentials

21 CFR Part 11 Quiz

Use these credentials to integrate the game into an LMS compatible with LTI 1.1 such as Canvas, Moodle, or Blackboard. This way, the scores will be automatically saved into the platform’s gradebook.

21 CFR Part 11 Quiz

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21 CFR Part 11 QuizOnline version

by Keerthana Premkumar

What does 21 CFR Part 11 regulate?

What industry does 21 CFR Part 11 apply to?

What is the purpose of 21 CFR Part 11?

What is an electronic signature?

What is the scope of 21 CFR Part 11?

What are the key requirements of 21 CFR Part 11?

It is an environment in which system access cannot be controlled by persons who are responsible for the content of electronic records that are on the system.

What is the penalty for non-compliance with 21 CFR Part 11?

An electronic signature based upon cryptographic methods of origination, authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified

What is the role of an electronic record in 21 CFR Part 11?

It is an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

Additional measures to be considered for open systems include which of the following?

What is the purpose of validation in 21 CFR Part 11?

What is the FDA's role in enforcing 21 CFR Part 11?

This is a method of verifying an individual's identity based on measurement of the individual's physical feature or repeatable action where those features and/or actions are both unique to that individual and measurable.