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Compliance Quiz: Picking Apart Part 11

1. CFR Title 21 Part 11 breaks down into 3 sections, which are:
2. Part 11 requires companies to use electronic records and signatures. True or False?
3. Under Definitions, sec. 11.3, (3), Part 11 states: "Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable." Currently, a common biometric security used on laptops is:
4. What is the difference between an Electronic and Digital signature?
5. Electronic records must have at least three elements of accompanying metadata:
6. What is the difference between "Closed" and "Open" systems?
7. According to Subpart C, 11.300, the electronic signature must be controlled to ensure they are securely stored and unique to one individual. A mechanism to ensure secure and unique e-signatures is:
8. Subpart C requires that persons using electronic signatures must certify in writing to the FDA that their electronic signature is: