Current Edition

Off the Record: The Truth about Data Integrity in Pharma

The Food and Drug Administration (FDA) has long emphasised

the importance of reliable data in pharmaceutical

manufacturing. Despite this clear recommendation, recent

FDA reports have highlighted an increase in data integrity

violations during several recent cGMP inspections. Lee

Sullivan, Regional Manager at HMI/SCADA and software

expert COPA-DATA UK, explores three data integrity

pitfalls to which pharmaceutical manufacturers are most