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.
Each and every time a user executes the electronic signature, all signature components
must be employed, even if the signings take place during one continuous period of controlled system access. T or F? - Answer - False. During one continuous period of controlled access the first signing employs all signature
components, with subsequent signings employing at least one component.
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. T or F? - Answer - True.
When signatures are based upon biometrics, they are intended to be used by the signer
and his/her designee. T or F? - Answer - False. Electronic signatures based upon biometrics are designed to ensure that they cannot be used by anyone other than their genuine owners.
There are five controls in place for identification codes and password procedures. Name
all of them. - Answer - 1. Maintaining uniqueness of codes and passwords. 2. Ensuring periodic check, recall and revision of codes and passwords. 3. Following loss management procedures to electronically de-authorize 1ost, stolen or compromised codes and passwords. 4. Use of safeguards to detect and prevent unauthorized use of es and passwords.
