What validation and management requirements apply to computerised systems used for GDP activities (such as WMS and ERP)?

Computerised systems used to manage critical GDP activities (such as warehouse management systems (WMS), enterprise resource planning systems (ERP) and temperature and humidity monitoring systems) must themselves be controlled to ensure that the data they generate are reliable, accurate and secure. These systems require Computer System Validation (CSV), with documented evidence demonstrating that they consistently meet their intended functions and regulatory requirements throughout their lifecycle. CSV generally follows the GAMP 5 (A Risk-Based Approach to Compliant GxP Computerized Systems) framework. Key management requirements include: 1. **Data integrity**: the system must be designed to ensure compliance with the ALCOA+ principles; 2. **Audit trail**: the system must automatically record all activities relating to the creation, modification and deletion of GxP data, including timestamps and operator information; 3. **Access controls**: grant users the minimum system access necessary for their roles and responsibilities; 4. **Backup and recovery**: validated procedures must be in place to back up data regularly and restore it reliably when required; 5. **Change control**: any changes to the system (such as software upgrades or configuration changes) must be managed through a formal change control procedure.