What is the purpose of a Data Audit?

• A. To calibrate instruments.
• B. To assess training needs.
• 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 data archiving.

Answer: (C)

The main idea tested is ensuring data integrity by checking that the measurement process is well-documented and followed, and that the results meet accepted quality criteria. A Data Audit involves reviewing both the documentation and the procedures used to generate measurements (SOPs, calibration records, method validation, data handling, audit trails) and evaluating the data itself against predefined acceptance criteria. This combination of qualitative checks (are records complete, is the method properly followed) and quantitative checks (are results within expected ranges, is calibration up-to-date) helps verify that the data are trustworthy and suitable for use. It’s not about calibrating instruments, which is calibration activity; not about assessing training needs, which is about competency; and not about archiving data, which is data management. The audit focuses on whether the measurement process and its documentation support data acceptability.