PwC says data integrity violations increasing

In a paper addressing data integrity among pharmaceutical manufacturers, PricewaterhouseCoopers said FDA issued 24 warnings for integrity violations from 2013-15, up from five warnings from 2010-12. PwC said the most common issues cited by FDA were a lack of safeguards to prevent data manipulation, improper recordkeeping and delayed data reporting.

All but one of the 29 total warnings were for violations outside the U.S., including 18 in India and six in China. PwC said 68.8% of all inspections were conducted in the U.S. ...