ændringskontrollere

ændringskontrollere is a Danish term used to describe the processes and the personnel responsible for change control in organizations. It refers to the structured management of changes to information systems, products, or processes to ensure that alterations are properly requested, evaluated, approved, implemented, and documented. The aim is to minimize risk, preserve traceability, and maintain regulatory compliance.

The change control lifecycle typically includes submitting a change request, performing impact and risk assessments, obtaining authorization (often from a Change Advisory Board or equivalent), planning the change, implementing it in a controlled manner, verifying the result, and closing the change with documentation. For urgent changes, expedited pathways may apply, but still require post-implementation review.

Key roles commonly involved are the ændringsleder or Change Manager, the Change Advisory Board (CAB), change initiators, testers, and audit or quality assurance personnel. Governance frameworks such as ITIL for IT services, GMP and GMP-compliant manufacturing in life sciences, and ISO 9001 quality systems commonly define the expectations for change control processes.

Benefits of effective ændringskontrollere include reduced operational risk, improved compliance, better versioning and audit trails, and clearer accountability. Challenges can include administrative burden, resistance to change, and ensuring timely approvals while maintaining rigorous validation and verification.

See also ITIL change management, change control in GMP, and ISO quality management systems.