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Questions and Answers
Which of the following statements is true about the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
Which of the following statements is true about the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
- The guidance is mandatory and cannot be deviated from.
- The guidance is applicable only to food and drug administration.
- The guidance creates legally binding requirements for all persons.
- The guidance represents the FDA's current thinking on the topic. (correct)
What does the FDA guidance on Part 11, Electronic Records; Electronic Signatures provide?
What does the FDA guidance on Part 11, Electronic Records; Electronic Signatures provide?
- Detailed instructions for implementing electronic records and signatures.
- Alternative approaches to electronic records and signatures.
- Legally binding requirements for all industries.
- Nonbinding recommendations for the food and drug administration. (correct)
What should be done if an alternative approach is desired for implementing the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
What should be done if an alternative approach is desired for implementing the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
- Obtain permission from any FDA staff member.
- Implement the alternative approach without informing the FDA.
- Contact the FDA staff responsible for implementing the guidance. (correct)
- Do not deviate from the guidance and follow it exactly as written.
What is the purpose of the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
What is the purpose of the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
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Can an alternative approach be used for implementing the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
Can an alternative approach be used for implementing the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
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