Who Wants To Be A 21 CFR 11 Expert?

23 Responses | Created by lauren17nit |
  1. 1

    What do the 21 CFR 11 regulations require when ID codes or passwords are lost, stolen, missing or otherwise potentially compromised?

  2. 2

    Part 11 is intended to apply to computer systems that:

  3. 3

    Which of the following must be unique in a 21 CFR 11-compliant system?

  4. 4

    Which of the following events preceded the issuance of the Advanced Notice of Proposed Rulemaking (ANPRM) and the Proposed Rule on e-Records and e-Signatures?

  5. 5

    21 CFR 11 regulations require that FDA be allowed to inspect the following:

  6. 6

    21 CFR 11 controls for biometric-based electronic signatures are designed to:

  7. 7

    Documentation important to demonstrate software validation includes:

  8. 8

    True or false? All changes to the system should be documented.

  9. 9

    What types of testing of ID codes and password devices, such as tokens or cards, are recommended by the FDA?

  10. 10

    E-records created before the August 20, 1997 effective date of the regulations:

  11. 11

    What is a "digital signature"?

  12. 12

    The FDA regards biometric-based electronic signatures to be:

  13. 13

    Can a computer software vendor claim that it is selling an "FDA-approved" or a "validated" product under 21 CFR 11 regulations?

  14. 14

    Which of the following is not considered an e-record under 21 CFR 11 definitions?

  15. 15

    Which of the following is NOT required to be available at a clinical study site during an FDA inspection?

  16. 16

    Which records are not within the scope of 21 CFR 11?

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