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Data Integrity and Automation

Posted by Rapid Micro Biosystems on September 29, 2015

The European Compliance Academy recently highlighted, “Another FDA Warning Letter with Focus on ‘Data Integrity’”.  The summary published by the ECA noted that an Indian API manufacturer received a warning letter from the US Food & Drug Administration highlighting 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”

The summary notes that, “Altogether there were great concerns about the authenticity and reliability of the data produced in this company.”

Often 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 capture of test results.

Learn how organizations can utilize automated rapid methods in pharmaceutical quality control labs this free guide.