John Lee talks about data integrity, statistics and trends.



In 2014 43 percent of warning letters issued to pharmaceutical companies had citations on data integrity.
The number raised to 70 percent. What happened?

FDA has expanded the definition and scope of the meaning of data integrity. Data integrity violation also happens if you delete data, cf. Part 11 requirement.

However, the greatest issue within data integrity is though security (missing password, stand alone IT systems not properly secured), not risk of falsification

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