Data integrity is vital for the pharmaceutical industry and organization shall be able to demonstrate the integrity of the data during regulatory audits. Review of various warning letters revealed that there are compromises w.r.t. data integrity and have resulted into serious implications on the organization including import alert and debarment of the employees.
It is always better to proactively prevent issues, such as data integrity failures to occur, than trying to remediate and resolve inspection findings. Compliance excellence makes good business sense.
This document provides the regulatory requirement, graphical summary of the issues in recent past through review of warning letters, suggest the strategy to prevent the data integrity breaches by design, by procedural control and monitoring.