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:

Design and operate a data integrity monitoring programme based on ALCOA+ principles. Covers detective controls, audit trail review schedules, anomaly detection patterns (off-hours activity, sequential modifications, bulk changes), metrics dashboards, investigation triggers, and escalation matrix definition. Use when establishing a data integrity monitoring programme for GxP systems, preparing for inspections where data integrity is a focus area, after a data integrity incident requiring enhanced monitoring, or when implementing MHRA, WHO, or PIC/S guidance. Source: pjt222/development-guides.