SOCRA Exam Questions and answers
Electronic signature are currently accepted for any and all records, paper or electronic form.
True or False? - 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? - 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.
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? - ANSWER>>False.
Record changes shall not obscure previously recorded information.
In electronic records, what do authority checks ensure? - 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? - 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? - 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? - ANSWER>>False,
What three elements are necessary for signed electronic records? - ANSWER>>a. The printed
name of the signer
b. The date and time when the signature was executed.
c. The meaning of the signature (such as review, approval, authorship).
Why is it necessary to link electronic signatures and handwritten signatures to the appropriate
electronic records? - ANSWER>>Linking ensures that the signatures cannot be excised copied,
or otherwise transferred to falsify an electronic record by ordinary means.
Each electronic signature can only be reused by one other person beyond the originator. T or F?
- ANSWER>>False.
Each one shall be unique and unable to be reused or reassigned to anyone else.
An organization must first verify the identity of the individual wishing to use an electronic
signature. T or F? - ANSWER>>True.
Certification of electronic signatures used on or after August 20, 1997 can be done
electronically. T or F? - ANSWER>>False.
Certification must be done in writing and sent to the FDA's Office of Regional Operations.
Once a person certifies their signature, an agency cannot request further certification, since it
was originally certified and submitted in writing. T F? - ANSWER>>False.
An agency can request further certification or testimony as to the legally binding equivalent or
the signer's handwritten signature.
When an electronic signature is not based upon biometrics, how many distinct identification
components must be employed? - ANSWER>>2 distinct components such as password and ID
code must be used.
Electronic signature are currently accepted for any and all records, paper or electronic form.
True or False? - 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? - 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.
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? - ANSWER>>False.
Record changes shall not obscure previously recorded information.
In electronic records, what do authority checks ensure? - 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? - 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? - 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? - ANSWER>>False,
What three elements are necessary for signed electronic records? - ANSWER>>a. The printed
name of the signer
b. The date and time when the signature was executed.
c. The meaning of the signature (such as review, approval, authorship).
Why is it necessary to link electronic signatures and handwritten signatures to the appropriate
electronic records? - ANSWER>>Linking ensures that the signatures cannot be excised copied,
or otherwise transferred to falsify an electronic record by ordinary means.
Each electronic signature can only be reused by one other person beyond the originator. T or F?
- ANSWER>>False.
Each one shall be unique and unable to be reused or reassigned to anyone else.
An organization must first verify the identity of the individual wishing to use an electronic
signature. T or F? - ANSWER>>True.
Certification of electronic signatures used on or after August 20, 1997 can be done
electronically. T or F? - ANSWER>>False.
Certification must be done in writing and sent to the FDA's Office of Regional Operations.
Once a person certifies their signature, an agency cannot request further certification, since it
was originally certified and submitted in writing. T F? - ANSWER>>False.
An agency can request further certification or testimony as to the legally binding equivalent or
the signer's handwritten signature.
When an electronic signature is not based upon biometrics, how many distinct identification
components must be employed? - ANSWER>>2 distinct components such as password and ID
code must be used.
