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16th October 2023  Content supplied by: Rapid Micro Biosystems

Trying to Initiate Confidence in Your Organizations Data Governance?

Data integrity, transcribed in the industry, as the manufacturers’ responsibility to govern their facilitie's processes, operational efficiencies, and quality control test data. Quality control microbiology processes and advancements in technology have been proven to improve organizations’ confidence in sound data and quality in the GMP manufacture of products.

At the height of regulatory scrutiny, it is invaluable that we learn from each other and share our expertise and insights into process enhancements and improvements in keeping patient safety top priority. As we know, microbiology laboratories historically process at risk when utilizing manual operations, forcing error-prone risks of data recording, subjective results reported, and arithmetic mistakes.

Our industry regulators are emphasizing the value and importance of the transition from manual, human error-prone microbiology methods to automated technologies. 

The Growth Direct®System automates incubation, detection, and enumeration, offering unprecedented capabilities to improve consistency, save time, reduce analyst error, capture data automatically, and manage control in confident results to maintain complete compliance with the stringent data integrity standards driving the industry.

In this webinar, you'll learn:
  • Importance of data integrity in quality control microbiology
  • Value of integrating automation software and technology to enhance data integrity
  • Regulatory expectations on data governance and quality risk management

Watch Now

It is extremely common for FDA Warning Letters to Focus on ‘Data Integrity,’ and a summary highlights several data integrity issues, including:
  • Activities were not recorded at the time they were carried out, and original data were deleted
  • Due to unauthorized access to data systems, data could be modified or deleted
  • There were no training protocols for the cGMP training of employees

Just to highlight a few, the summary notes that altogether there are great concerns about the authenticity and reliability of the data produced in companies that have yet to implement advances to their technologies to improve and secure data governance. With automation, workflow integration, and digital transformation technologies available, regulators question quality control processes that have not yet implemented and validated these advanced methods for routine use.

These types of data issues are the result of manual operations that lack the processes and controls to ensure the security and integrity of data. 

Automated technologies can provide system security and audit trails such that only authorized users can manipulate data and that manipulation is tracked and reportable. In addition, automated capture of sample data ensures the comprehensiveness and timeliness of any reporting.

While process improvements and controls are critical to any operation, the addition of automated technologies can enhance the security and auditability of data. Technologies such as the Growth Direct® System include 21 CFR Part 11 compliant software that provides password security and a full audit trail of activities, reducing the risk of a data integrity issue. In addition, integration to LIMs ensures no errors in the capture of test results.

If you have additional questions about automating rapid microbial detection and enumeration for your QC microbiology, visit Rapid Micro Biosystems or click on the "Request Information" button below to contact the supplier.

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Date Published: 16th October 2023

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