Removing Gaps in Data Integrity

Between January 2015 and May 2016 there was a total of 28 warning letters issued to pharmaceutical manufacturers. 21 of those letters were centered around issues involving data integrity.  If data is mutilated and changed, it does not promise that a product is safe, data integrity is extremely important to follow.  It is used to assure the consistency of the life-cycle of a product. In 2017, Merck & Co. had a hacking incident involving their data; this cost them $105 million to fix and could have been prevented by using a data security system.  All data was mangled and/or lost, it was unclear to what data was correct or not.

For starters, the FDA created a guidance that clarified the best practices to track data in 2016.  The ALCOA acronym was introduced to manufactures to remind them while tracking is occurring—“attributable, legible, contemporaneous, original (or a true copy), and accurate”.  Soon after, in December 2018, the FDA updated the guidance to clarify what they expect from written data.  This guidance is used to give manufacturers a better understanding with inputting lifecycle data, creating a structure for controls and clarifies the importance for all data collecting.

The Identifier software will track data and product defects.  This software makes data integrity easy to follow, disabling data to be altered or falsified.  The data is now unreachable outside of the manufacturer—preventing incidents like Merck & Co.

To learn more about the importance of data integrity, read the full article published by

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