Module 12 2019

Data Integrity Issues

– Failures by organizations to apply robust systems that inhibit data risks, to improve the detection of situations where data reliability may be compromised – Lack of adequate investigation and remediation of root causes when failures do arise. For example: – Validated computerized systems but fail to adequately review and manage original electronic records – Often only review and manage incomplete and/or inappropriate printouts

The Organisation for Professionals in Regulatory Affairs