A closer look at data integrity

Published: 23-May-2018
Regulatory

NSF conducted extensive research into warning letters issued from 2005 to 2017 for data integrity deficiencies. In this white paper, George Toscano takes a deeper look into where companies were struggling most and provides some essential advice

Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010.

A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue to grapple with data integrity issues.

Click here to access the full paper.

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