Lack of data integrity is the main reason for most FDA warning letters.
For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available for audits. Storing results is not enough: each dataset must be complete and contain all relevant metadata.
The Laboratory Data Integrity Guide illustrates safe ways to attain data integrity, with examples of analytical workflows and discussion of where data integrity might be at risk. Secure your measuring processes: learn more about data handling, SOP guidance and achieving data integrity.
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