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.
The Result
The required audit trail functionality was successfully retrofitted, and thanks to the extensive configuration options of Smart Audit Trail<sup>(c)</sup>, the device now meets the highest standards of data integrity and compliance. It was safely released for GxP use and has since been established as a reference system—paving the way for future investments in this type of analytical device. With the now available detailed setup report, the client is fully prepared for the next audit.
