What is 21 cfr 11 Study guides, Class notes & Summaries

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - 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 elect...

DOT QUESTIONS AND ANSWERS FULLY SOLVED 1. Which of the following is true? *The FMCSA does not consider feasibility or impact in the rule-making process. *Only the Medical Review Board can provide advice and opinions on FMCSA rulemaking. *FMCSA medical standards and guidelines are subject to public notice and comment rulemaking. *The Code of Federal Regulations provide guidance that the medical examiner may or may not follow. FMCSA medical standards and guidelines are subject to p...

SOCRA CCRP Exam Practice Questions and answers, VERIFIED/ 21 CFR part 11 regulates? - -Electronic Signatures What is the name of FDA Form 483? - -Inspectional Observation What does 21CFR56 regulate? - -Institutional Review Boards An application for Investigational Device Exemption is part of 21 CFR part ____________? - -812 Define Electronic Signature - -A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding...

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Establishment of and adherence to written procedures - A. T...

OSHA 30 CONSTRUCTION TEST ANSWER KEY INTRODUCTION TO OSHA – LATEST VERSION ALREADY PASSED The CFR Parts, such as Part 1926 for Construction, are further broken down into ___________, which group together specific and detailed standards. A. Bullets B. Pieces C. Slices D. Subparts D. Subparts (correct answer) Get OSHA 30 Exam Passed - 1. When the employer receives an OSHA citation, it must be: A. Contested and filed with the courts B. Copied and mailed to each worker C...

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic records. D Establishment of and adherence to written procedures - A. T...

CITI Training Exam Review Questions With Complete Solutions Latest Update (Graded A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does th...

NRCME-Exam Questions and Answers 100% Verified What are regulations? - answerLaws that must be followed What are disqualifying medical conditions? - answerEpilepsy monocular vision hearing loss What are guidelines? - answerRecommendation to follow but can have raptor ale for variation FMCSA medical program responsibilities include: Oversee the Department of Transportation. Regulation of intrastate commercial motor vehicle operations. Conduct and oversee the agency's medical exemption...

RAC Practice Exam 1 Questions and Answers New Version 2024 Complete Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic re...

NRCME-Exam Questions and Answers 100% Verified What are regulations? - answerLaws that must be followed What are disqualifying medical conditions? - answerEpilepsy monocular vision hearing loss What are guidelines? - answerRecommendation to follow but can have raptor ale for variation FMCSA medical program responsibilities include: Oversee the Department of Transportation. Regulation of intrastate commercial motor vehicle operations. Conduct and oversee the agency's medical exemption...