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SOCRA Exam Questions With 100% Correct And Verified Answers
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SOCRA Exam Questions With 100% Correct And Verified Answers
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SOCRA Exam Questions With 100%Correct And Verified Answers
Electronic signature are currently accepted for any and all records, paper
or electronic form. True or False? - Correct Answer-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? -
Correct Answer-True
Electronic records cannot be used in lieu of paper records. True or False?
- Correct Answer-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? - Correct Answer-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? - Correct Answer-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? - Correct Answer-True.
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,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? - Correct Answer-True
Who determines the details for electronic submission (e.g. methods of
transmission, media, file formats and technical protocol)? - Correct
Answer-The 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? - Correct Answer-Act means the Federal Food, Drug and
Cosmetic Act.
In the FDA's Electronic Signatures regulation, what does the term agency
refer to? - Correct Answer-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? - Correct Answer-Biometrics
What does the term closed system mean with regard to electronic
records? - Correct Answer-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? - Correct Answer-False.
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,
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,maintained, archived, retrieved, or distributed by a computer
system is known as what? - Correct Answer-Electronic Record.
Electronic signature and digital signature are synonymous terms. or
F? - Correct Answer-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? - Correct Answer-Handwritten signature
How does open system differ from closed system with regards to the
FDA's Electronic Records regulations? - Correct Answer-In an open
system access is not controlled by persons who are responsible for
the content of electronic records that are on the system
Why is validation of systems an important procedure and control
for closed systems? - Correct Answer-Validation of systems ensures
accuracy, reliability, consistency of intended performance, and the
ability to discern invalid or altered records
The ability to generate complete and accurate copies of records in
both human readable and electronic form suitable for inspection,
review, and copying by the agency is a control established for closed
systems. T or F? - Correct Answer-True.
Closed systems are limited to authorized individuals only. T or F? -
Correct Answer-True.
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, 21. A procedure in place as a control for closed systems includes the
use of secure, computer-generated, time-stamped audit trails to
independently record the date and time of operator entries. Changes
made to the records may obscure and delete previous recorded
information, so that the most current information, will always be
accessible. T or F? - Correct Answer-False.
Record changes shall not obscure previously recorded information.
In electronic records, what do authority checks ensure? - Correct
Answer-Authority checks ensure that only authorized individuals
can use the system, electronically sign a record, access the computer
system's input and output devices, alter a record, or perform other
operations at hand.
A control procedure for closed systems requires the determination
that persons who develop, maintain or use electronic
record/electronic signature systems have the proper training,
education and experience to perform the assigned task. T or F? -
Correct Answer-True.
Persons or organizations desiring to use electronic records are not
required to have written policies that hold individuals accountable
and responsible for actions initiated under the electronic signatures,
because the nature of electronic records does not permit falsification. T or
F? - Correct Answer-False
Persons who use open systems are not bound to any of the controls or
procedures established by the closed system. T or F? - Correct Answer-
False,
What three elements are necessary for signed electronic records? -
Correct Answer-a. The printed name of the signer
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