monitor-data-integrity

Design and operate a programme that continuously monitors data integrity across validated systems using ALCOA+ principles and anomaly detection.

Expected: Every system has a rated ALCOA+ assessment with specific findings for each principle. On failure: If a system cannot be assessed (e.g., no audit trail capability), flag it as a critical gap requiring immediate remediation.

Define the monitoring activities that detect data integrity violations:

根據 ALCOA+ 原則設計和執行資料完整性監控程式。涵蓋偵測控制、稽核追蹤審查計畫、異常偵測模式（非工作時間活動、順序修改、批次變更）、指標儀表板、調查觸發器和升級矩陣定義。在為 GxP 系統建立資料完整性監控計畫、準備以資料完整性為重點領域的檢查時、在需要加強監控的資料完整性事件發生後或在實施 MHRA、WHO 或 PIC/S 指南時使用。 來源：pjt222/development-guides。