Stay in control about your data

Data Integrity Assessments

Objective

In recent years, regulatory agencies have seen an increase in unintentional and intentional breaches of data integrity policies. As a result, inspections have become more focused on good documentation practices and data management. The goal of a data integrity assessment is to identify vulnerabilities and implement measures to protect your data. Data integrity assessment should be performed as a first step towards implementing a holistic, compliant and secure data management system.

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Examples

Source of requirements
  • FDA
  • MHRA
  • WHO
  • PIC/S
  • EMA
  • Company requirements
  • Country specific regulations
Inventar-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