21 CFR Part 11

Question 1

What does 21 CFR Part 11 cover?

Answer 1

applies to issues related to electronic documents, electronic systems, and electronic signatures which are used in FDA related clinical trials

Question 2

electronic signature

Answer 2

A computer data compilation executed, adopted or authorized by an individual to be the legally binding equivalent of their handwritten signature

Question 3

electronic record

Answer 3

information in digital form that is created, modified, maintained, and archived, retrieved or distributed by a computer system

Question 4

closed system

Answer 4

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

Question 5

open system

Answer 5

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

Question 6

electronic data capture

Answer 6

web based systems which are used for recording clinical trial data

Question 7

source document

Answer 7

electronic or paper records of medical notes, record, labs, results, images which support the data collected and recorded in a clinical trial

Question 8

E-source documents

Answer 8

elements that can be transferred directly from one computer system to another without manipulation

Question 9

digital signature

Answer 9

It is an electronic signature based on crypotgraphic methods of originator authentication, computer by using a set of rules and set of parameters such that the identity of the signer and the integrity of the data can be verified.

Question 10

biometrics

Answer 10

it is a method of verifying an individual’s identity based on measurement of the individual’s physical features or repeatable actions .

Question 11

ACT

Answer 11

The Federal Food, Drug, and Cosmetic Act

Question 12

agency

Answer 12

FDA

Question 13

General Requirements for electronic signatures

3 conditions

Answer 13

• Each electronic signature should be unique & not be reused or reassigned to anyone else.
• Before the organization certifies the signature they have to verify the identity of the individual.
• Persons shall certify that electronic signatures used after 20AUG1997 are legally binding.

Question 14

Electronic signatures NOT based on biometrics (3 conditions)

Answer 14

• employ at least two distinct identification components (ID code and password).
• be used only by genuine owners.
• use of the signature by anyone other than its genuine owner requires collaboration of two or more individuals.

Question 15

Electronic signatures that ARE based on biometrics

5 conditions

Answer 15

• maintain the uniqueness of each ID code and pw
• Ensure that the ID code and pw issuances are periodically checked, recalled, or revised.
• Following loss management procedures to electronically deauthorize lose, stolen, missing or otherwise potentially compromised tokens, cards, and other devices.
• use of transaction safeguards to prevent unauthorized use of pws and/or ID codes
• initial and periodic testing of devices that bear or generate id code or pw info.