What data security and compliance requirements apply to a computerised inventory management system (WMS) used in a medicine warehouse?

A computerised Warehouse Management System (WMS) is central to modern pharmaceutical distribution, and its data security and compliance are critical. First, the system must be validated to demonstrate that it is accurate, reliable and consistent, and can meet all GDP requirements, such as expiry-date management and batch traceability. Second, the system must have robust access controls, with different permissions for users in different roles, such as warehouse administrators and quality managers, to prevent unauthorised changes to data. The creation, amendment or deletion of all critical data must be recorded in an immutable audit trail, showing ‘who, when, where and what was changed’. Third, reliable data backup and recovery procedures must be in place to prevent data loss caused by system failure, cyberattacks or disasters. The recoverability of backup data should be tested regularly.