Microbiology, like all laboratory processes, is subject to data integrity, which is a serious potential quality concern outlined in several US Food and Drug Administration (FDA) warning letters.


Microbiology laboratories, even those implementing rapid methods, handle a lot of data, often in different forms (qualitative and quantitative).


To have integrity, data must be attributable, legible (permanent), contemporaneous, original and accurate, principles known as ALCOA. 


These standards apply whether you use conventional or rapid microbiological methods (RMM), and processes using paper or computerised documentation.


A key data integrity concern with conventional environmental monitoring methods is that these traditional culture-based methods have inherent variability, which the FDA has highlighted as a concern in warning letters.


To combat these issues Dr Sandle suggests training in testing and reading plates, as well as potentially implementing rapid methods.


For RMMs, he stated that data integrity issues typically arise around design, validation and operation, and include concerns around data retention, archiving and processing. 


When carrying out reviews of rapid microbiological methods five general and important data integrity questions are:

  • Is electronic data available?
  • Is electronic data reviewed?
  • Is meta data (audit trails) reviewed regularly?
  • Are there clear segregation of duties?
  • Has the system been validated for its intended use?


Writet: Dr. Tim Sandle, Ph.D. (CBiol, FIScT)