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Data Integrity Failures Undermine Trust That Can’t Easily Be Won Back, EMA Official Says

 
• By Anju Ghangurde

A forum on quality excellence in India saw global regulators highlight regulatory requirements and expectations in critical areas such as data integrity and the investigation of compliance-related complaints. The fostering of a quality culture was another key theme at the event, with one EMA speaker noting there are no easy fixes when trust in data is broken.

Data Integrity

The India Pharmaceutical Forum 2017 saw officials from the European Medicines Agency, the US Food and Drug Administration and other regulatory bodies identify critical issues around quality challenges for industry, including those pertaining to data integrity. Compliance trends in Indian manufacturing were also a major topic at the event.

Brendan Cuddy, head of manufacturing and quality compliance at the European Medicines Agency, said that data integrity issues were “corrosive” to good science and to the trust that underpins the...

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