Retrofitting and Software Updates for Legacy Devices and Systems in GxP Environments
- Client: Mid-sized Pharmaceutical Company – Germany Site
The Challenges
The client operated several aging systems in production as well as devices in R&D environments that no longer met current regulatory requirements for data integrity and compliance. Among them were critical systems that fundamentally required the retrofitting of audit trail functionality. The quality departments were aiming for more data-driven efficiency and a significantly higher level of data integrity and compliance to ensure safe operations. The devices and systems were still operational and had been commissioned at considerable effort and cost.
The Solution
In a multi-stage process, we conducted Data Integrity Assessments on all affected devices and systems, identifying audit-relevant and critical aspects for each piece of equipment. This allowed us to configure Smart Audit Trail<sup>(c)</sup> with precision and accelerate the audit trail review process in the context of the retrofit by a factor of 10 to 15. The project was carried out in close coordination with the client’s Data Integrity, Compliance, and Operations teams. Every modification was documented within the system. The final evaluation confirmed the project’s success, and it was officially handed over to the client.
The Result
Thanks to supplementary software updates installed on the control PCs, the upgraded devices and systems now fully comply with all regulatory requirements related to GxP, 21 CFR Part 11, as well as data integrity and compliance. The key advantage: the equipment did not need to be expensively replaced but could be retrofitted at a much lower cost. This resulted in significant budget savings and extended the operational life of the systems. With the newly available detailed setup reports for each unit, the company is now well-prepared for any upcoming audit.
