SOCRA Actual Certification Exam 2024 questions and answers A-graded

SOCRA Actual Certification Exam 2024 questions and answers A-graded Electronic Records - CORRECT ANSWER-Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine Electronic Records - Audit Trail - CORRECT ANSWER-Electronic records must use secure, computer generated, time-stamped audit trails to independently record the date and time of entries and actions that create, modify or delete records. Electronic Records - Changes - CORRECT ANSWER-Record changes must not obscure previously recorded information Electronic Records - Audit Trail Retention - CORRECT ANSWER-Audit trail documentation must be retained for a period at least as long as that required for the subject electronic records and must be available for agency (FDA) review and copying. Electronic records - Controls over systems documentation - CORRECT ANSWER-1. Controls over the distribution of, access to, and use of documentation for system operation and maintenance 2. Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation Electronic records - Open system - CORRECT ANSWER-Procedures and controls must be used to ensure the authenticity, integrity and confidentiality of electronic records from the point of creation to the point of receipt. Examples: Encryption, Use of digital signatures Signed Electronic Records - CORRECT ANSWER-Must contain information associated with the signing that clearly indicate all of the following: 1. Printed name of signer 2. Date and time when signature was executed 3. Meaning (such as review, approval, responsibility or authorship) associated with signature Electronic Signature Verification - CORRECT ANSWER-Before any organization establishes, assigns, certifies or otherwise sanctions an individual's electronic signature, the identity of the individual must be verified Electronic Signature Certification - CORRECT ANSWER-Prior to using their electronic signature, one must certify to the agency that the electronic signatures in their system