Data integrity has ascended to the scale of priority under which FDA regulators would have considered it across the arenas of pharmaceuticals, biotechnology, and medical devices. The integrity of data now becomes critical for regulatory participation-evidences being complete, right, and trustworthy. The FDA encourages and conducts enforcement actions for updated guidance pertaining to data integrity, particularly as more firms utilize digital mechanisms to manage data.

Inspections by the FDA of late have revealed numerous data integrity violations leading to warning letters, import alerts, and in some cases withdrawal application. Irrespective of the geographical boundaries of the nation, improper data governance by organizations can face severe ramifications usually in the form of regulatory penalties and reputational damage. 

The current newsletter refers to some of the recent regulatory updates, identifiable common compliance challenges, and the most effective best practices that assist organizations in moving forward with the fast-changing landscape of data integrity.