Top 21 CFR Part 11 Interview Questions and Answers

As the life sciences industry continues to embrace digital transformation, compliance with 21 CFR Part 11 has become a crucial aspect for organizations dealing with electronic records and electronic signatures. This regulation, issued by the Food and Drug Administration (FDA), outlines the requirements for ensuring the integrity, authenticity, and confidentiality of electronic records and signatures.

If you’re preparing for an interview related to 21 CFR Part 11, it’s essential to have a solid understanding of the regulation’s key concepts, requirements, and best practices. In this article, we’ll explore the top 21 CFR Part 11 interview questions and provide comprehensive answers to help you ace your interview.

1. What is 21 CFR Part 11?

21 CFR Part 11 is a regulation issued by the FDA that provides guidelines for companies operating in FDA-regulated industries, such as pharmaceuticals, medical devices, and biotechnology, to ensure the integrity and authenticity of electronic records and electronic signatures.

2. What is the main purpose of 21 CFR Part 11?

The main purpose of 21 CFR Part 11 is to establish criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures executed on paper.

3. Who needs to comply with 21 CFR Part 11?

Any organization operating in FDA-regulated industries, such as pharmaceuticals, biotechnology, medical devices, and related fields, that uses electronic records and electronic signatures must comply with 21 CFR Part 11.

4. What are the key requirements of 21 CFR Part 11?

The key requirements of 21 CFR Part 11 include:

• Validation of computer systems to ensure accuracy, reliability, and consistent performance
• Implementation of audit trails to record data changes and activities
• Use of operational and device checks to ensure proper system functioning
• Implementation of authorized access controls and security measures
• Maintaining records throughout their retention period
• Ensuring electronic signatures are legally binding and linked to their respective electronic records

5. What is an electronic record according to 21 CFR Part 11?

According to 21 CFR Part 11, an electronic record is any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

6. What is an electronic signature according to 21 CFR Part 11?

An electronic signature, as defined by 21 CFR Part 11, is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

7. What are the requirements for electronic signatures under 21 CFR Part 11?

The requirements for electronic signatures under 21 CFR Part 11 include:

• Use of unique identification codes and passwords for each individual
• Periodic review and revision of identification codes and passwords
• Implementation of loss management procedures for lost or stolen identification codes and passwords
• Use of transaction safeguards to prevent unauthorized use of identification codes and passwords
• Periodic testing of the identification code and password issuance systems

8. What is an audit trail according to 21 CFR Part 11?

An audit trail, as defined by 21 CFR Part 11, is a secure, computer-generated, time-stamped electronic record that allows for the reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record.

9. What are the requirements for audit trails under 21 CFR Part 11?

The requirements for audit trails under 21 CFR Part 11 include:

• Being secure and protected from unauthorized access
• Being computer-generated and time-stamped
• Containing information about who made changes, what changes were made, and when
• Being retained for at least as long as the corresponding electronic records
• Being readily available for FDA review and copying
• Not obscuring previously recorded information

10. What is computer system validation according to 21 CFR Part 11?

Computer system validation, according to 21 CFR Part 11, is the process of ensuring that a computer system meets its intended use and complies with all applicable regulations. It aims to ensure the authenticity, integrity, and, when appropriate, confidentiality of electronic records.

11. What is the recommended approach for validating electronic systems?

The recommended approach for validating electronic systems is a risk-based approach, as outlined in industry guidelines such as ISPE GAMP5. This approach prioritizes validation activities based on the system’s risk and impact on product quality, data integrity, and patient safety.

12. What is the difference between open and closed systems in 21 CFR Part 11?

The difference between open and closed systems in 21 CFR Part 11 lies in the level of control over system access:

• Closed systems refer to environments where system access is controlled by individuals responsible for the electronic records.
• Open systems refer to environments where system access is not controlled by individuals responsible for the electronic records’ content.

Additional security measures may be required for open systems to ensure compliance with 21 CFR Part 11.

13. What are operational system checks according to 21 CFR Part 11?

Operational system checks, as defined by 21 CFR Part 11, are measures implemented within electronic systems to enforce the proper sequencing of steps and events, ensuring that operations are performed in the intended order and that any deviations or unauthorized actions are detected and addressed promptly.

14. What are device checks according to 21 CFR Part 11?

Device checks, according to 21 CFR Part 11, are procedures implemented to verify the validity and reliability of data input sources or operational instructions in electronic systems. These checks assess the integrity of the devices used to interact with the system, ensuring the accuracy and appropriateness of the data entered or instructions provided.

15. What training requirements are required for 21 CFR Part 11 compliance?

21 CFR Part 11 requires that individuals who use electronic record and signature systems have the appropriate education, training, and experience to perform their assigned tasks. Training records must be documented and subject to the same requirements as any electronic record within the scope of 21 CFR Part 11.

16. What is a policy of responsibility for using electronic signatures?

A policy of responsibility for using electronic signatures is a written document that outlines the rules and guidelines regarding the use of electronic signatures within an organization. It holds individuals accountable and responsible for their actions initiated under their electronic signatures, preventing record and signature falsification.

17. What documentation requirements apply to 21 CFR Part 11 compliant systems?

21 CFR Part 11 compliant systems must follow documentation requirements, including controlling the distribution, access, and use of system documentation for operation and maintenance purposes. Additionally, it involves implementing revision and change control procedures that maintain an audit trail documenting the chronological development and modification of the system documentation.

18. How can you identify if a system is compliant with 21 CFR Part 11?

To identify if a system is compliant with 21 CFR Part 11, you can request the software vendor to provide proof of compliance. This may include documentation of system validation, information on access and security controls, security procedures for incident response, and records of audits or inspections conducted to ensure compliance.

19. What is the difference between 21 CFR Part 11 and EU Annex 11?

The key differences between 21 CFR Part 11 and EU Annex 11 are:

• Jurisdiction: 21 CFR Part 11 applies to FDA-regulated industries in the United States, while EU Annex 11 applies to manufacturers of medicinal products within the European Union member states.
• Regulatory status: Compliance with 21 CFR Part 11 is mandatory for companies performing FDA-regulated activities, while EU Annex 11 is a guideline, and compliance is optional.

20. What is the difference between 21 CFR Part 11 and ISPE GAMP5?

The main difference between 21 CFR Part 11 and ISPE GAMP5 is their regulatory status and purpose:

• 21 CFR Part 11 is a part of the regulation specific to the United States, outlining requirements for electronic records and signatures in FDA-regulated industries.
• ISPE GAMP5 is an international guidance document that provides a risk-based approach for the validation of computerized systems.

21. How can an eQMS (Electronic Quality Management System) help with 21 CFR Part 11 compliance?

An eQMS can help with 21 CFR Part 11 compliance by providing a comprehensive software solution that facilitates the management of electronic records, signatures, and quality documentation. Features like secure data storage, limited system access, time-stamped audit trails, electronic signatures, and employee training support can align with 21 CFR Part 11 requirements.

Preparing for 21 CFR Part 11 interviews can be challenging, but with a thorough understanding of the regulation’s key concepts and requirements, you can demonstrate your expertise and increase your chances of success. Remember to stay updated with the latest developments and industry best practices to ensure your knowledge remains relevant and valuable.