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SOCRA Exam Questions and Answers 100% Solved | Graded A+

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SOCRA Exam Questions and Answers 100% Solved | Graded A+ Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, a...

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  • October 25, 2024
  • 78
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • SOCRA
  • SOCRA
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SOCRA Exam Questions and Answers

100% Solved | Graded A+


Electronic signature are currently accepted for any and all records, paper or

electronic form. True or False? - ✔✔False. The general provisions for

electeonic signature criteria apply to records that are



i. Created, modified, maintained, archived, retrieved, or transmitted, in

electronic form



ii. The criteria do not apply to paper records that are or have been

transmitted by electronic means.

If the electronic records meet the criteria specified in 21 CFR 11, thr

agency will consider the electronic signatures, initials, and other general

signing equivalent to full handwritten signatures, unless specifically

excepted by regulations effective after August 20, 1997. True or False? -

✔✔True

,©JOSHCLAY 2024/2025. YEAR PUBLISHED 2024.
Electronic records cannot be used in lieu of paper records. True or False? -

✔✔False.



Electronic records that meet the requirements may be used in lieu of paper

forms, unless paper records are specifically required.

provisions are subject to whose inspection? - ✔✔The FDA's inspection

Provided they meet the requirements, persons can use electronic records

lieu of paper records, for records required to be maintained, but not

submitted to the agency. True or False? - ✔✔True.

Persons can use electronic records in lieu of paper records for documents

required to be submitted to the agency provided the document has been

identified as a type of submission that the FDA will accept in electronic

format. T or F? - ✔✔True.

Documents submitted to the FDA that are not specified in the public docket

as acceptable in electronic form, will not be considered as official if they are

submitted in electronic form. T or F? - ✔✔True

Who determines the details for electronic submission (e.g. methods of

transmission, media, file formats and technical protocol)? - ✔✔The

,©JOSHCLAY 2024/2025. YEAR PUBLISHED 2024.
intended receiving agency unit will determine the details of electronic

submission.

In the FDA's regulations covering electronic signatures, what does the term

Act refer to? - ✔✔Act means the Federal Food, Drug and Cosmetic Act.

In the FDA's Electronic Signatures regulation, what does the term agency

refer to? - ✔✔Agency refers to the Food and Drug Administration

What is the term that means a method of verifying an individual's identity

based on measurement of the individual's physical feature(s) or repeatable

actions(s) where those features and/or actions are both measurable and

unique to that individual? - ✔✔Biometrics

What does the term closed system mean with regard to electronic records?

- ✔✔Closed system means environment in which system access is

controlled by persons who are responsible for the content of the electronic

records that are in the system.

An electronic signature is 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. T or F? - ✔✔False.

, ©JOSHCLAY 2024/2025. YEAR PUBLISHED 2024.
This is the definition for the term digital signature.

Any combination of text, graphics, data, pictorial, audio, or other

information representation in digital form that is created, modified,

maintained, archived, retrieved, or distributed by a computer system is

known as what? - ✔✔Electronic Record.

Electronic signature and digital signature are synonymous terms. or F? -

✔✔False.



Electronic signature means a computer data complilatiom of any symbol or

series of symbols executed and authorized by an individual to be the legally

binding equivalent of the handwritten signature. A digital signature is based

upon cryptographic methods or originator authentication, a set of computed

by using rules and a set of parameters such that the identity of the signer

and the integrity of the data can be verified.

What type of signature is the scripted name or legal mark of an individual

preserved with a writing or marking instrument such as a pen or stylus? -

✔✔Handwritten signature

How does open system differ from closed system with regards to the FDA's

Electronic Records regulations? - ✔✔In an open system access is not

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