Retrofitting Audit Trail Functionality to a High-Performance Analytical Instrument for GxP Use
- Client: European Biotechnology Company – Laboratory Environment
The Challenges
After an extensive search and laborious testing phase, the client had finally identified a device that met the specific requirements of its research project. However, as the device was originally designed for a different industry, it did not include any built-in audit trail functionality. This meant the client could not deploy the device in a GxP-regulated environment as-is.
The Solution
Through a comprehensive Data Integrity Assessment, we analyzed the device for audit-relevant and critical aspects, along with specific characteristics that needed to be addressed. Based on these findings, we configured and retrofitted Smart Audit Trail© in a highly targeted way.
From the moment the system was commissioned, this setup enabled the audit trail review process to be accelerated by a factor of 10 to 15. The project was executed in close collaboration with the device owner and the client’s quality assurance department.
