UBM India announces 4th Annual Data Integrity, Reliability and Quality Metrics Workshop 2018
Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues. Indicators of potential Data Integrity issues are an unreasonably low number of deviations, OOS incidents and EM excursions. Regulatory non-compliance is always a serious area of concern for the Indian pharmaceutical sector. With 13 warning letters being issued in FY 2015 and 9 warning letters in FY 2016, Data Integrity still continues to be a severe problem to be tackled.