Stay in control of your data
Data Integrity Assessments
Objective
Over the last couple of years, authorities recognized an increase of unintended and intended violations against data integrity guidelines. Hence the focus during inspections on good documentation practices and data management increased. The objective of a data integrity assessment is to identify weak points and implementing measures to protect data. The data integrity assessment should be the first activity to implement holistic, compliant and secure data management.
Examples
Source of Requirements
- FDA
- MHRA
- WHO
- PIC/S
- EMA
- Company regulations
- Country regulations
Inventory Items
- MES (Manufacturing Execution System)
- Data Historian
- PLC (Programmable Logic controller)
- LIMS (Laboratory Information Management System)
- Laboratory Equipment (e.g. HPLC)
- HMI (Human Machine Interfaces)
- DCS (Distributed Control System)
- User Management
- Data Stewardship