Glossary
Process Owner
The person responsible for the proper operation of the business process that a computerised system supports.
Source · EudraLex Volume 4, Annex 11 (2011), Glossary: Process owner
Details
The process owner is responsible for ensuring that business requirements, intended use, data review, and day to day operation are correctly reflected in the system's functionality. Inspections cite unclear responsibility for URS approval, risk assessment, procedures and training, the business impact of a change, and data review. Check the role description, the URS, risk assessments, SOPs and training, and change, deviation, and periodic review records.
Related sections
Related terms
Source
EudraLex Volume 4, Annex 11 (2011), Glossary: Process ownerGRM Regulatory Glossary
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