Monday, 18 June 2018

Automated, Digital Colony Counting: Qualification and Data Integrity

Many laboratory managers have given attention to automated, digital devices to streamline the plate counting processes. Such devices have been commonplace to the clinical laboratory for some time; although adoption within pharmaceutical laboratories has been slower. Recent regulatory interest in data integrity and the economic pressures driving the ‘lean’ laboratory, with a focus on cost control, improving sample throughput, and reviewing whether each sample tested adds value or produces meaningful information, may account for the growing interest.

This paper considers the selection and adoption of automated, digital capture colony counters within the pharmaceutical microbiology laboratory. The focus is on how such devices can be qualified (or validated) and how data integrity concerns can be addressed, provided that the former has been appropriately planned and executed.

To understand how these devices work, and how accurate they are, plus how data integrity considerations must be handled, Tim Sandle has written a paper for the Journal of GxP Compliance.

The reference is:

For details, contact Tim Sandle

Posted by Dr. Tim Sandle

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