5 Questions
Which of the following statements is true about the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
The guidance represents the FDA's current thinking on the topic.
What does the FDA guidance on Part 11, Electronic Records; Electronic Signatures provide?
Nonbinding recommendations for the food and drug administration.
What should be done if an alternative approach is desired for implementing the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
Contact the FDA staff responsible for implementing the guidance.
What is the purpose of the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
To describe the FDA's current thinking on the topic.
Can an alternative approach be used for implementing the FDA guidance on Part 11, Electronic Records; Electronic Signatures?
Yes, as long as it satisfies the requirements of the applicable statutes and regulations.
Test your knowledge on Part 11 Electronic Records Electronic Signatures Scope and Application with this informative quiz. Find out if you are familiar with the guidance provided by the FDA and the recommendations it contains.
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