21 CFR 11

Question 1

What is the purpose of 21 CFR Part 11?

Answer 1

The purpose is to define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.

Question 2

How does 21 CFR Part 11 define an electronic record?

Answer 2

An electronic record is any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computerized system.

Question 3

Define the term “electronic signature” according to 21 CFR Part 11.

Answer 3

An electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

Question 4

Which FDA-regulated industries are subject to 21 CFR Part 11?

Answer 4

Part 11 applies to pharmaceuticals, biologics, medical devices, food, and other industries that are subject to FDA regulations.

Question 5

Are there any exemptions from compliance with 21 CFR Part 11?

Answer 5

Part 11 applies to all FDA-regulated industries, but certain records, such as paper records, and specific low-risk functions may be exempt.

Question 6

According to 21 CFR Part 11, what are the controls for closed systems to ensure the integrity of electronic records?

Answer 6

Closed systems must have controls for limiting system access, restricting authority for changes, and documenting changes.

Question 7

How does 21 CFR Part 11 address the issue of record retention for electronic records?

Answer 7

Part 11 requires the establishment of procedures to ensure the secure retention of electronic records and to enable their accurate and ready retrieval throughout the record retention period.

Question 8

What are the key components of electronic signature controls under 21 CFR Part 11?

Answer 8

Electronic signature controls must include user authentication, access controls, and the use of digital signatures.

Question 9

Can an electronic signature be used for any purpose under 21 CFR Part 11?

Answer 9

No, electronic signatures are only valid if they are used for intended purposes and if the associated electronic records are accurate, reliable, and maintained securely.

Question 10

According to 21 CFR Part 11, what is the purpose of an audit trail for electronic records?

Answer 10

Audit trails are required to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

Question 11

How does 21 CFR Part 11 address the security of audit trails?

Answer 11

Part 11 requires the use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries.

Question 12

What is the importance of validating electronic systems under 21 CFR Part 11?

Answer 12

Validation ensures that electronic systems perform as intended, and the data they generate is accurate, reliable, and secure.

Question 13

How often should the validation of electronic systems be conducted, according to 21 CFR Part 11?

Answer 13

Validation should be performed during the development and modification of systems and should be re-assessed periodically.

Question 14

What are the key elements of the validation process for computerized systems under 21 CFR Part 11?

Answer 14

Validation includes requirements such as documenting system specifications, testing to ensure system functions, and establishing procedures for ongoing system maintenance.

Question 15

According to 21 CFR Part 11, what is the importance of the “system validation documentation”?

Answer 15

System validation documentation provides evidence that the computerized system meets its predetermined specifications and intended use.

Question 16

How does 21 CFR Part 11 address risk management in the context of electronic records and signatures?

Answer 16

The regulation emphasizes conducting a risk assessment to identify potential hazards and implementing measures to mitigate risks associated with electronic systems.

Question 17

What factors should be considered in the risk assessment process according to 21 CFR Part 11?

Answer 17

Factors include the complexity of the system, its intended use, and the potential impact on data integrity and patient safety.

Question 18

Explain the concept of “biometric electronic signatures” as outlined in 21 CFR Part 11.

Answer 18

Biometric electronic signatures use unique physiological characteristics such as fingerprints or retinal patterns as a means of identifying and authenticating individuals.

Question 19

According to 21 CFR Part 11, what requirements must be met for an electronic signature to be considered trustworthy?

Answer 19

Electronic signatures must be unique to the individual, securely linked to the record, and controlled by the authorized user.

Question 20

How does 21 CFR Part 11 address the integrity of audit trails?

Answer 20

Audit trails must be protected to prevent unauthorized access and modification, ensuring that they remain a reliable and accurate record of system activities.

Question 21

What is the significance of the “time stamp” in the context of audit trails under 21 CFR Part 11?

Answer 21

Time stamps provide an accurate record of when specific actions or events occurred within the electronic system, supporting traceability and accountability.

Question 22

According to 21 CFR Part 11, what requirements must be met for the secure retention of electronic records?

Answer 22

Electronic records must be stored to prevent loss or deterioration, and procedures must be in place to ensure their secure retrieval throughout the record retention period.

Question 23

How does 21 CFR Part 11 address the issue of record copying and backup?

Answer 23

The regulation requires procedures for creating backup copies of records and ensures that copies are complete and accurate.

Question 24

What training requirements does 21 CFR Part 11 impose on personnel involved in electronic recordkeeping systems?

Answer 24

Personnel must be trained in the use of electronic systems and procedures, emphasizing the importance of accurate and secure data management.

Question 25

How does 21 CFR Part 11 address the concept of “role-based access control”?

Answer 25

Role-based access control ensures that individuals have access only to the electronic records and functions necessary for their roles in the organization.

Question 26

What are the subparts/titles of 21 CFR Part 11?

Answer 26

Subpart A- General Provisions
Subpart B- Electronic Records
Subpart C- Electronic Signatures