(2 Ratings)

21 CFR Part 11 Electronic Records; Electronic Signatures

Categories: Auditing, Quality Tools, Regulations, Standards

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About Course

Build your understanding of the FDA’s requirements for electronic records and electronic signatures. This self-paced course covers 21 CFR Part 11, including system controls, record protection, and the safeguards that keep signatures linked to their records.

Whether you work in quality assurance, regulatory compliance, IT, validation, or a laboratory, you’ll learn how these requirements apply to electronic information in FDA-regulated environments. Complete the course and pass the final exam to earn your Certificate of Completion.

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Subpart A—General Provisions
SUBPART A – GENERAL PROVISIONS includes 11.1 – Scope, 11.2 – Implementation, and 11.3 – Definitions

Subpart B—Electronic Records
SUBPART B – ELECTRONIC RECORDS includes 11.10 – Controls for closed systems, 11.30 – Controls for open systems, 11.50 – Signature manifestations, and 11.70 – Signature/record linking

Subpart C—Electronic Signatures
SUBPART C – ELECTRONIC SIGNATURES includes 11.100 – General requirements, 11.200 – Electronic signature components and controls, and 11.300 – Controls for identification codes/passwords

21 CFR Part 11 Electronic Records; Electronic Signatures Final Exam
This final exam is administered to demonstrate the participant’s understanding and comprehension of the course materials. A score of 80% or greater is required to receive a Certificate of Completion. <img src="/wp-content/uploads/2026/03/Industry-Specific-Online-Learning-and-Certification-FInal-Exam.jpg" />

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About Course

What Will You Learn?

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Subpart A—General Provisions
SUBPART A – GENERAL PROVISIONS includes 11.1 – Scope, 11.2 – Implementation, and 11.3 – Definitions

§ 11.1 Scope.

§ 11.2 Implementation.

§ 11.3 Definitions.

Subpart A—General Provisions Quiz

Subpart B—Electronic Records
SUBPART B – ELECTRONIC RECORDS includes 11.10 – Controls for closed systems, 11.30 – Controls for open systems, 11.50 – Signature manifestations, and 11.70 – Signature/record linking

§ 11.10 Controls for closed systems.

§ 11.30 Controls for open systems.

§ 11.50 Signature manifestations.

§ 11.70 Signature/record linking.

Subpart B—Electronic Records Quiz

Subpart C—Electronic Signatures
SUBPART C – ELECTRONIC SIGNATURES includes 11.100 – General requirements, 11.200 – Electronic signature components and controls, and 11.300 – Controls for identification codes/passwords

§ 11.100 General requirements.

§ 11.200 Electronic signature components and controls.

§ 11.300 Controls for identification codes/passwords.

Subpart C—Electronic Signatures Quiz

21 CFR Part 11 Electronic Records; Electronic Signatures Final Exam

Earn a Certificate

About Course

What Will You Learn?

Course Content

Acknowledgements and Attestation

Submit Acknowledgements and Attestation

Subpart A—General Provisions SUBPART A – GENERAL PROVISIONS includes 11.1 – Scope, 11.2 – Implementation, and 11.3 – Definitions

§ 11.1 Scope.

§ 11.2 Implementation.

§ 11.3 Definitions.

Subpart A—General Provisions Quiz

Subpart B—Electronic Records SUBPART B – ELECTRONIC RECORDS includes 11.10 – Controls for closed systems, 11.30 – Controls for open systems, 11.50 – Signature manifestations, and 11.70 – Signature/record linking

§ 11.10 Controls for closed systems.

§ 11.30 Controls for open systems.

§ 11.50 Signature manifestations.

§ 11.70 Signature/record linking.

Subpart B—Electronic Records Quiz

Subpart C—Electronic Signatures SUBPART C – ELECTRONIC SIGNATURES includes 11.100 – General requirements, 11.200 – Electronic signature components and controls, and 11.300 – Controls for identification codes/passwords

§ 11.100 General requirements.

§ 11.200 Electronic signature components and controls.

§ 11.300 Controls for identification codes/passwords.

Subpart C—Electronic Signatures Quiz

21 CFR Part 11 Electronic Records; Electronic Signatures Final Exam

Earn a Certificate

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Subpart A—General Provisions
SUBPART A – GENERAL PROVISIONS includes 11.1 – Scope, 11.2 – Implementation, and 11.3 – Definitions

Subpart B—Electronic Records
SUBPART B – ELECTRONIC RECORDS includes 11.10 – Controls for closed systems, 11.30 – Controls for open systems, 11.50 – Signature manifestations, and 11.70 – Signature/record linking

Subpart C—Electronic Signatures
SUBPART C – ELECTRONIC SIGNATURES includes 11.100 – General requirements, 11.200 – Electronic signature components and controls, and 11.300 – Controls for identification codes/passwords