Regulatory Affairs

Data Integrity A Closer Look

Published 31 May 2018 | By NSF International

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.

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Data Integrity A Closer Look