The Objective

The client needed to implement a Data Integrity (DI) Assessment process and perform an assessment on a manufacturing process in preparation for an upcoming regulatory audit.

The Challenge

The process had to be implemented, users trained, and DI assessments performed on multiple systems prior to the audit date whilst not impact manufacturing.

The Solution

Integrity worked with the client to develop the process and conduct the Data Integrity Assessments.

This included:​

  • Delivering Data Integrity training with all the personnel who were going to be involved in the project.​
  • Conducting Process & Data mapping to identify data flows and GxP data elements. And highlighting the electronic GxP data that can be modified/deleted or re-processed after creation.​
  • Performing a System Categorization. Resulting in identifying the data severity level by the impact on product quality/patient safety and the system category based on the data generated by the system.​
  • Performing System Assessment(s) using a DI check list and the System Category.​
  • Analysing the DI risk by conducting a risk assessment on the gaps identified and impact on GxP data that can be modified/deleted or re-processed after creation.​
  • Developing a Risk Management Plan with actions and priorities to address risks identified, remediate the gaps and set priorities based on the magnitude of the risk.​
The Outcome
  • Required assessments planned and completed on time. ​
  • Management plan was completed which identified the immediate and long-term actions. ​
  • Establishes a solid foundation for understanding Data Integrity and supports the Quality system.​
  • Reduced risks and improved process control.​
  • Increased awareness of Data Integrity.​
  • The process and tools required to support Data Integrity are now in place.