SOCRA Exam Questions with Complete Solutions (Latest 2025) Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - Correct Answers ✅False. The general provisions for electeonic signature criteria apply to records that are
- 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? - Correct Answers ✅True Electronic records cannot be used in lieu of paper records.True or False? - Correct Answers ✅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? - Correct Answers ✅The FDA's inspection 1 / 4
SOCRA Exam Questions with Complete Solutions (Latest 2025) 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? - Correct Answers ✅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? - Correct Answers ✅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? - Correct Answers ✅True Who determines the details for electronic submission (e.g.methods of transmission, media, file formats and technical protocol)? - Correct Answers ✅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? - Correct Answers ✅Act means the Federal Food, Drug and Cosmetic Act. 2 / 4
SOCRA Exam Questions with Complete Solutions (Latest 2025) In the FDA's Electronic Signatures regulation, what does the term agency refer to? - Correct Answers ✅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? - Correct Answers ✅Biometrics What does the term closed system mean with regard to electronic records? - Correct Answers ✅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? - Correct Answers ✅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 3 / 4
SOCRA Exam Questions with Complete Solutions (Latest 2025) distributed by a computer system is known as what? - Correct Answers ✅Electronic Record.Electronic signature and digital signature are synonymous terms. or F? - Correct Answers ✅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? - Correct Answers ✅Handwritten signature How does open system differ from closed system with regards to the FDA's Electronic Records regulations? - Correct Answers ✅In an open system access is not controlled by persons who are responsible for the content of electronic records that are on the system
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