Glossary
Data Governance
The sum of the organisational and technical arrangements that assure data integrity, whatever the format or technology.
Details
Data governance places ownership, accountability, culture, procedures, and technical controls across the whole data lifecycle within the pharmaceutical quality system. Inspections cite systems that lack senior management accountability, data criticality and risk assessment, a culture in which errors are reported, control over contract giver access to data, and periodic review of effectiveness. Check the governance policy, the accountability structure, data flow and risk assessments, training and self-inspection, and management review and improvement plans.
