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Compliance Quiz: Part 11 and the Predicate Rules

1. Predicate rules are FDA regulations that were created _____________CFR 21 Part 11 at a timewhen records and signatures were still made with_________ and _______.
2. The two CFR titles relevant to Pharmaceutical manufacturing are:
3. 21 CFR Part 11 came into being to allow ______ rules to be satisfied by a computer system that creates and stores records or signatures.
4. True or False? Part 11 determines record creation, content, signature requirements or retention period, or Original vs. Copy to be archived.
5. Which of the following is NOT regulation on digital or electronic signatures?
6. Copy of Which of the following is NOT regulation on digital or electronic signatures?
7. Records and Signatures are subject to Part 11 IF:
8. Which of the rules below is not a predicate rule?
9. Does this predicate rule fall under 21 CFR Part 11? Part 211—GMP for Finished Pharmaceuticals, Section: § 211.68, "For Automatic, Mechanical, and Electronic Equipment" states: "[equipment or computer systems] shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained."
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