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 the US Food nad Drug Administration (FDA), the Medicines and Healthcare Products regulatory Agency (MHRA), the European Medicines Agency (EMA), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organisation (WHO), and yet companies continue to grapple with data integrity issues.

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