With the release of Data Integrity guidelines from FDA, MHRA, EMA and other regulatory bodies across the globe, data integrity compliance received limelight across the industry since 2015.  Looking at the trend of increase in warning letters on Data Integrity non-compliance, the industry jumped immediately into Remediation exercises to achieve compliance with the Data Integrity […]

On December 2018, the FDA published the Final Guide for Data Integrity in the regulated industry.  But even before that, the FDA has been pounding the industry with findings related to Data Integrity.  All FDA-regulated companies are currently working on Data Integrity and everybody is talking about the topic.  Are we really focusing on the […]

While Data Integrity continues to occupy the top spot in C-suite issues, issuance of 483 and Warning Letters continues unabated. The prime cause for this is the inability of companies to address Data Integrity holistically. No longer can companies afford to view this issue as confined to a few areas of their operation. Instead it […]