Regulatory Affairs Certification (RAC) Practice Exam

Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)?

1. Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records.

2. Validation of systems to ensure accuracy.

3. Authority checks to ensure that only authorized personnel can create, modify or delete electronic records.

4. Establishment of and adherence to written procedures.

The correct answer is: Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records.

The correct choice identifies that manually generated timestamped audit trails are not a requirement for compliance under 21 CFR Part 11. Instead, the regulation mandates that systems must have automated audit trails that capture the date and time of operator entries and actions related to electronic records. The use of automated systems is emphasized to ensure the integrity and reliability of the records. In the context of the other requirements: - The validation of systems is pivotal to ensure that the electronic records are accurate, consistent, and reliable over their lifecycle. This is a fundamental principle of compliance under 21 CFR Part 11, as it ensures that the systems perform as intended. - Authority checks are crucial for protecting the integrity of electronic records. This includes ensuring that only authorized individuals have access to create, modify, or delete records, which prevents unauthorized changes and maintains data integrity. - Establishing and adhering to written procedures is essential for ensuring that there are clear guidelines and processes in place for handling electronic records and signatures. This not only supports compliance but also helps in maintaining consistent practices across an organization. In summary, while features like audit trails are necessary, they must be automated rather than manually generated, thus making the identification of manual timestamping as non-compliant under this regulation.