What is a Data Audit?

• A. A qualitative evaluation of equipment performance only.
• B. A quantitative evaluation of data values only.
• C. A qualitative and quantitative evaluation of the documentation and procedures associated with measurements to verify that the resulting data are acceptable.
• D. A process for calibrating instruments.

Answer: (C)

Data audit is about checking the entire process that produces data, not just the numbers or the instruments alone. It combines qualitative and quantitative review to ensure the data are trustworthy and acceptable for use. Qualitative aspects look at the paperwork and how measurements were made: Are SOPs clear and followed? Is the documentation complete, legible, and properly version-controlled? Are the procedures, roles, and approvals well defined? Quantitative aspects examine the actual data and the supporting evidence: Are calibration and validation records current and valid? Do measurements fall within specified acceptance criteria? Is there traceability from the data to the original measurements and metadata, and is the data consistent and complete?

When you put these together, you’re verifying that the data result from a controlled, well-documented process and meet predefined quality standards, rather than just assessing the equipment or the numerical values in isolation. That’s why the best answer describes a qualitative and quantitative evaluation of the documentation and procedures to verify that the resulting data are acceptable.