Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data integrity is a key regulatory concern and guidance documents have been produced by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Moreover, data integrity in relation to the microbiology laboratory features in several FDA warning letters, especially in relation to sample handling and reading.
This is the subject of a new paper from Tim Sandle. The reference is:
Sandle, T. (2016) Data Integrity Considerations for the Pharmaceutical Microbiology Laboratory, Journal of GXP Compliance, 20 (6): 1-12
The paper can be found on the IVT website here.
Posted by Dr. Tim Sandle