On-Device audit trail in the dissolution laboratory - removing the shackles of the PC

Audit trails are a cornerstone of modern dissolution testing, ensuring traceability, regulatory compliance, and data integrity. Traditionally, implementing them required an external PC and dedicated software — adding complexity, increasing costs, and introducing additional points of failure.

This presentation explores a new on-device approach to audit-trail management, where recording and reviewing compliance data takes place directly within the dissolution tester itself. By eliminating the dependency on external computer systems, laboratories benefit from significantly reduced validation effort, as there is no longer a need to validate separate Windows-based software installations. Likewise, the entire management of Windows PCs in GMP environments disappears — no patching cycles, no antivirus qualification, no domain policies, and no constant maintenance overhead.

We will examine how this streamlined architecture simplifies laboratory infrastructure, reduces administrative burden, enhances usability, and improves efficiency. With intuitive interfaces and integrated compliance functions, on-device audit trails enable laboratories to meet regulatory requirements more effectively while lowering operational overhead, training demands, and long-term ownership costs.