SOCRA STUDY GUIDE CERTIFICATION
PRACTICE 2026 QUESTIONS SOLUTIONS
VERIFIED GRADED A+
⩥ 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?
Answer: True
⩥ Electronic records cannot be used in lieu of paper records. True or
False? 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? 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? 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? Answer: 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? Answer: True
⩥ Who determines the details for electronic submission (e.g. methods of
transmission, media, file formats and technical protocol)? 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? Answer: Act means the Federal Food, Drug and
Cosmetic Act.
⩥ In the FDA's Electronic Signatures regulation, what does the term
agency refer to? 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? Answer: Biometrics
,⩥ What does the term closed system mean with regard to electronic
records? 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? 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,
maintained, archived, retrieved, or distributed by a computer system is
known as what? Answer: Electronic Record.
⩥ Electronic signature and digital signature are synonymous terms. or
F? 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? Answer: Handwritten signature
⩥ How does open system differ from closed system with regards to the
FDA's Electronic Records regulations? 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? 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? Answer: True.
⩥ Closed systems are limited to authorized individuals only. T or F?
Answer: True.
PRACTICE 2026 QUESTIONS SOLUTIONS
VERIFIED GRADED A+
⩥ 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?
Answer: True
⩥ Electronic records cannot be used in lieu of paper records. True or
False? 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? 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? 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? Answer: 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? Answer: True
⩥ Who determines the details for electronic submission (e.g. methods of
transmission, media, file formats and technical protocol)? 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? Answer: Act means the Federal Food, Drug and
Cosmetic Act.
⩥ In the FDA's Electronic Signatures regulation, what does the term
agency refer to? 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? Answer: Biometrics
,⩥ What does the term closed system mean with regard to electronic
records? 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? 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,
maintained, archived, retrieved, or distributed by a computer system is
known as what? Answer: Electronic Record.
⩥ Electronic signature and digital signature are synonymous terms. or
F? 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? Answer: Handwritten signature
⩥ How does open system differ from closed system with regards to the
FDA's Electronic Records regulations? 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? 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? Answer: True.
⩥ Closed systems are limited to authorized individuals only. T or F?
Answer: True.
