Module 12 Presentations

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