21 CRF Part 11

Question 1

Scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark

Answer 1

Handwritten signature

Question 2

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

Answer 2

Electronic signature

Question 3

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

Answer 3

Closed system

Question 4

Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Answer 4

electronic record

Question 5

An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system

Answer 5

Open system

Question 6

An electronic signature based upon cryptographic methods of originator 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.

Answer 6

Digital signature

Question 7

A method of verifying an individual’s identity based on measurements of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

Answer 7

Biometrics

Question 8

Electronic signatures not based on biometrics should have how many distinct ID components?

Answer 8

2

ex: ID code and password

Question 9

What 3 additional details need to accompany a signature in a signed electronic record?

Answer 9

• Printed name of signer
• Date and time the signature was executed
• Responsibility of the signer (ex: review, approval)

Question 10

Are computer systems subject to FDA inspection

Answer 10

Yes

Question 11

Which part in the 21 Code of Federal Regulations discusses electronic records and electronic signatures?

Answer 11

Part 11