Monitor Data Integrity

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

When to Use

• Establishing a data integrity monitoring programme for GxP systems
• Regulatory inspection preparation where data integrity is a focus area
• After a data integrity incident requiring enhanced monitoring
• Periodic review of existing data integrity controls
• Implementing MHRA, WHO, or PIC/S data integrity guidance

Inputs

• Required: Systems in scope and their ALCOA+ risk profile
• Required: Applicable guidance (MHRA Data Integrity, WHO TRS 996, PIC/S PI 041)
• Required: Current audit trail capabilities of each system
• Optional: Previous data integrity findings or regulatory observations
• Optional: Existing monitoring procedures or metrics