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:

根据 ALCOA+ 原则设计和运行数据完整性监控程序。涵盖检测控制、审计跟踪审查计划、异常检测模式（非工作时间活动、顺序修改、批量更改）、指标仪表板、调查触发器和升级矩阵定义。在为 GxP 系统建立数据完整性监控计划、准备以数据完整性为重点领域的检查时、在需要加强监控的数据完整性事件发生后或在实施 MHRA、WHO 或 PIC/S 指南时使用。 来源：pjt222/development-guides。