
PwC Report Examines Data Integrity Issues in Pharma
The report examines the increased number of companies cited by regulators for data integrity issues.
According to a
PwC’s Health Research Institute (HRI) conducted a
HRI notes the three most common issues cited by FDA between 2013–2015 were lack of controls to prevent alterations of data by staff, a failure to maintain records of accurate data, and delayed reporting of data. HRI says violations were disproportionately found in countries outside of the US. Of the 29 data integrity violation letters sent by FDA between 2010 and 2015, 18 were sent to Indian companies and 6 to Chinese companies.
HRI says “warnings may be increasing in the wake of new authority and financial resources given to the FDA by Congress in 2012.” FDA has been increasing foreign drug quality inspections; the rate of inspections has increased from 20.6% in 2010 to 39.2% in 2015, according to PwC estimates.
HRI cites three industry implications of the increased focus on data integrity:
- Global industry reach-FDA’s expanding global presence may mean more companies will have their foreign manufacturing practices scrutinized.
- Data integrity violations may shut down facilities-HRI writes companies should ensure workers value integrity and have effective incentives to meet quality standards.
- Using technology to prevent problems-HRI asserts technology solutions can help companies avoid data integrity issues.
Source:
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