Data Integrity is a word that has been thrown all around the pharma and med device space in the past 5 years, especially in the past 3 years since the start of the COVID pandemic. With the industry changing speed we have been shown that trials can receive funding and subjects. The public visibility of vaccine studies data and evidence backed research is being scrutinized at record highs. Social media has allowed for an immediate global conversation around safety, efficacy, and transparency.

The reliability of records from research through manufacturing is critical. Yet so many companies have difficulty with document organization, management, and retrieval. In 2020, the American Pharmaceutical Review published Data Integrity: 2020 FDA Data Integrity Observations in Review.

This paper outlines multiple recent violations of FDA data integrity guidelines, some include:

• Sample abortion without clear and justifiable cause
• Data documented before or significantly after the work was completed
  • Delayed review of Logbook/Notebook/Batch Records
• Data loss and/or destruction
  • A chromatography machine was tampered with in March 2020, resulting in peaks outside of the target range not being reported.
  • Missing quality data from analytical testing
  • Testing run outside of validated systems

These issues are easy to identify, but there are also smaller and simpler was for data manipulation and data loss. Messy desks, employee turnover, technician guilt from failing test results.

Your data is your reputation. Make sure yours gives governing agencies, medical professionals, and future patients comfort and security that your product will make them better.