Regulatory Affairs Certification (RAC) Practice Exam

What is the significance of maintaining electronic records under 21 CFR Part 11?

1. Improved record retrieval times.

2. Enhanced data security and integrity.

3. Reduced compliance costs.

4. Increased accessibility to users.

The correct answer is: Enhanced data security and integrity.

Maintaining electronic records under 21 CFR Part 11 is significant primarily due to the enhanced data security and integrity that it provides. This regulation establishes the criteria for trustworthiness and equivalence of electronic records to traditional paper records. By ensuring that electronic records are created and maintained in a secure manner, organizations can protect sensitive data from unauthorized access, alteration, or loss. Key elements such as audit trails, user authentication, and data encryption contribute to the overall integrity of these records, which is crucial in regulated environments like pharmaceuticals and biotechnology. While improved record retrieval times, reduced compliance costs, and increased accessibility are important factors in the management of electronic records, the essence of 21 CFR Part 11 focuses on creating a framework that guarantees the reliability and security of electronic documentation. Enhanced data security and integrity not only support compliance with regulatory standards but also foster trust in the information's authenticity and accuracy, which is vital for both regulatory submissions and internal quality assurance processes.