SOCRA CERTIFICATION 2026 EXAM
SCRIPT COMPLETE SOLVED
QUESTIONS
◉ Part 11, Subpart A: General Provisions.
Answer: -must be trustworthy, reliable, and generally equivalent to
paper records
-applies to electronic forms that are created, modified, maintained,
archived, retrieved, or transmitted
-where records meet requirements, it will be considered equivalent to
full handwritten signatures, initials, etc.
-must be available and subject to FDA inspection
-may be in lieu of paper records or traditional signatures if they meet the
above requirements and have been identified in public docket (making it
official)
◉ Part 11: Closed system.
Answer: an environment in which system access is controlled by persons
who are responsible for the content of electronic records that are on the
system.
◉ Part 11: Digital signatures.
Answer: an electronic signature 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.
◉ Part 11: Electronic record.
Answer: any combination of text, graphics, data, audio, pictorial, or
other information representation in digital form that is created, modified,
maintained, archived, retrieved, or distributed by a computer system.
◉ Part 11: Electronic signature.
Answer: A computer data compilation of any symbol or series of
symbols executed, adopted, or authorized by an individual to be the
legally binding equivalent of the individual's handwritten signature.
◉ Part 11: Handwritten signature.
Answer: the scripted name or legal mark of an individual handwritten by
that individual and executed or adopted with the present intention to
authenticate a writing in a permanent form. The act of signing with a
writing or marking instrument such as a pen or stylus is preserved. The
scripted name or legal mark, while conventionally applied to paper, may
also be applied to other devices that capture the name or mark.
◉ Part 11: Open system.
Answer: an environment in which system access is not controlled by
persons who are responsible for the content of electronic records that are
on the system.
,◉ Part 11, Subpart B: Electronic Records
Controls for closed systems.
Answer: Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, when appropriate, the
confidentiality of electronic records, and to ensure that the signer cannot
readily repudiate the signed record as not genuine.
Includes:
-validation of system
-ability to generate accurate and complete copies of records for
inspection, review, etc.
-Protection
-limiting system to auth. individuals
-secure, time-stamped, audit trails
-enforcement of permitted sequencing of steps
-authority checks to make sure only auth. people using
-establishment and adherence to policies for accountability and
deterrence of sig falsification
◉ Part 11, Subpart B: Electronic Records
Controls for opens systems.
Answer: Persons who use open systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation to
, the point of their receipt. Such procedures and controls shall include
those identified in §11.10, as appropriate, and additional measures such
as document encryption and use of appropriate digital signature
standards to ensure, as necessary under the circumstances, record
authenticity, integrity, and confidentiality.
◉ Part 11, Subpart B: Electronic Records
Signature manifestations.
Answer: Must contain:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship)
associated with the signature.
◉ Part 11, Subpart B: Electronic Records
Signature/record linking.
Answer: Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic records to
ensure that the signatures cannot be excised, copied, or otherwise
transferred to falsify an electronic record by ordinary means.
◉ Part 11, Subpart C: Electronic Signatures
General requirements.
Answer: -shall be unique
-organization shall verify identity of person providing electronic
signature before making it official
SCRIPT COMPLETE SOLVED
QUESTIONS
◉ Part 11, Subpart A: General Provisions.
Answer: -must be trustworthy, reliable, and generally equivalent to
paper records
-applies to electronic forms that are created, modified, maintained,
archived, retrieved, or transmitted
-where records meet requirements, it will be considered equivalent to
full handwritten signatures, initials, etc.
-must be available and subject to FDA inspection
-may be in lieu of paper records or traditional signatures if they meet the
above requirements and have been identified in public docket (making it
official)
◉ Part 11: Closed system.
Answer: an environment in which system access is controlled by persons
who are responsible for the content of electronic records that are on the
system.
◉ Part 11: Digital signatures.
Answer: an electronic signature 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.
◉ Part 11: Electronic record.
Answer: any combination of text, graphics, data, audio, pictorial, or
other information representation in digital form that is created, modified,
maintained, archived, retrieved, or distributed by a computer system.
◉ Part 11: Electronic signature.
Answer: A computer data compilation of any symbol or series of
symbols executed, adopted, or authorized by an individual to be the
legally binding equivalent of the individual's handwritten signature.
◉ Part 11: Handwritten signature.
Answer: the scripted name or legal mark of an individual handwritten by
that individual and executed or adopted with the present intention to
authenticate a writing in a permanent form. The act of signing with a
writing or marking instrument such as a pen or stylus is preserved. The
scripted name or legal mark, while conventionally applied to paper, may
also be applied to other devices that capture the name or mark.
◉ Part 11: Open system.
Answer: an environment in which system access is not controlled by
persons who are responsible for the content of electronic records that are
on the system.
,◉ Part 11, Subpart B: Electronic Records
Controls for closed systems.
Answer: Persons who use closed systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, when appropriate, the
confidentiality of electronic records, and to ensure that the signer cannot
readily repudiate the signed record as not genuine.
Includes:
-validation of system
-ability to generate accurate and complete copies of records for
inspection, review, etc.
-Protection
-limiting system to auth. individuals
-secure, time-stamped, audit trails
-enforcement of permitted sequencing of steps
-authority checks to make sure only auth. people using
-establishment and adherence to policies for accountability and
deterrence of sig falsification
◉ Part 11, Subpart B: Electronic Records
Controls for opens systems.
Answer: Persons who use open systems to create, modify, maintain, or
transmit electronic records shall employ procedures and controls
designed to ensure the authenticity, integrity, and, as appropriate, the
confidentiality of electronic records from the point of their creation to
, the point of their receipt. Such procedures and controls shall include
those identified in §11.10, as appropriate, and additional measures such
as document encryption and use of appropriate digital signature
standards to ensure, as necessary under the circumstances, record
authenticity, integrity, and confidentiality.
◉ Part 11, Subpart B: Electronic Records
Signature manifestations.
Answer: Must contain:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship)
associated with the signature.
◉ Part 11, Subpart B: Electronic Records
Signature/record linking.
Answer: Electronic signatures and handwritten signatures executed to
electronic records shall be linked to their respective electronic records to
ensure that the signatures cannot be excised, copied, or otherwise
transferred to falsify an electronic record by ordinary means.
◉ Part 11, Subpart C: Electronic Signatures
General requirements.
Answer: -shall be unique
-organization shall verify identity of person providing electronic
signature before making it official
