SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide

SOCRA EXAM PREP | 2024/ 2025 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide 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 - ANSWER Electronic Records 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. - ANSWER Electronic Records - Audit Trail Record changes must not obscure previously recorded information - ANSWER Electronic Records - Changes 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. - ANSWER Electronic Records - Audit Trail Retention 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 - ANSWER Electronic records - Controls over systems documentation 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 - ANSWER Electronic records - Open system