FDA Guidance on Part 11 Electronic Records and 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)

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)

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.

<p>To describe the FDA's current thinking on the topic.</p> Signup and view all the answers

<p>Yes, as long as it satisfies the requirements of the applicable statutes and regulations.</p> Signup and view all the answers