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SOCRA CCRP Certification fully solved & updated (100- accuracy)
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SOCRA CCRP Certification fully solved & updated (100- accuracy)
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SOCRA CCRP Certification2025-2026 fully solved &
updated (100- accuracy)
CFR Title 21: Part 11 - answer Electronic Records; Electronic Signatures
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
-person using electronic signature should acknowledge that is is legally
binding
-Persons using electronic signatures shall, upon agency request, provide
additional certification or testimony that a specific electronic signature is
the legally binding equivalent of the signer's handwritten signature.
Part 11, Subpart C: Electronic Signatures
, Electronic signature components and controls - answer (a) Electronic
signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components(i.e., ID code and
password)
(i) When an individual executes a series of signings during a single,
continuous period of controlled system access, the first signing shall be
executed using all electronic signature components; subsequent signings
shall be executed using at least one electronic signature component that
is only executable by, and designed to be used only by, the individual.
(ii) When an individual executes one or more signings not performed
during a single, continuous period of controlled system access, each
signing shall be executed using all of the electronic signature
components.
(2) Be used only by their genuine owners; and
(3) Be administered and executed to ensure that attempted use of an
individual's electronic signature by anyone other than its genuine owner
requires collaboration of two or more individuals.
(b) Electronic signatures based upon biometrics shall be designed to
ensure that they cannot be used by anyone other than their genuine
owners.
Part 11, Subpart C: Electronic Signatures
Controls for identification codes/passwords - answer (a) Maintaining the
uniqueness of each combined identification code and password
(b) Ensuring that identification code and password issuances are
periodically checked, recalled, or revised
(c) Following loss management procedures to electronically deauthorize
lost, stolen, missing, or otherwise potentially compromised tokens, cards,
and other devices that bear or generate identification code or password
(d) Use of transaction safeguards to prevent unauthorized use of
passwords and/or identification codes, and to detect and report in an
immediate and urgent manner any unauthorized attempts
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