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