Pioneering Diagnostics

Ensuring Data Integrity by Automated Microbiology Testing

Microbiology testing in pharmaceutical development and manufacture is used for environmental monitoring, sterility testing and detection and identification of microorganisms and the applicable regulations for this work are Good Manufacturing Practice (GMP).
Currently, data integrity is a major issue in the pharmaceutical industry and citations from FDA warning letters for microbiology laboratories can be classified as:

  • Failure to perform actual testing
  • Falsification of data e.g. reporting failed tests as passes or modifying records

The reasons are that microbiological testing is often manual and data often relies on observation that can be manipulated, often without photographs of the plates.

To find out more about Data Integrity embedded in microbiology:
fill in the form to download our Whitepaper.

About the authors

Sandra Gay, phD
is Pharma Marketing Manager at bioMérieux.
See Sandra Linkedin Profile


Yves Samson 
Automation and system engineer
He is member of GAMP Europe Steering Committees, chairman and cofounder of GAMP Francophone


Dr R D McDowall

Dr Robert McDowall provides management consultancy for the pharmaceutical, agrochemical and chemical industries

Tips for successfully integrating a Data Integrity approach in microbiology:

  • Data Integrity shouldn’t be looked at it in an isolated way. Follow the data during the whole process
  • Compliancy with ALCOA
  • Integrate audit trails, multiple user ID levels, automated reports and connectivity
  • When choosing a partner, ensure your IT team communicates with your partners' IT team when implementing new traceability solutions like connectivity, remote access etc.