SOCRA Exam Questions & Answers 100% Correct

ACT - ANSWER-Federal food drug and cosmetic acts agency - ANSWER-Food and Drug Administration Biometrics - ANSWER-Method of verifying ID based on measurement of physical features, repeatable features, where those features and/or actions are both unique to that individual and measurable closed system - ANSWER-Environment in which the system access is controlled by persons who are responsible for the content of electronic records that are on the system open system - ANSWER-Environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system Closed system procedures include - ANSWER-Validation systems- accuracy reliability ability to generate accurate complete copies of records both in human and electronic form for inspection review and copying by agency protection limited to authorized individuals secure - time stamped Ich E6 (R2) - ANSWER-Non binding, agency is current thinking on GCP. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approach may be used