Validating Interfaces Between GxP Systems: Data Transfers, APIs, Middleware, and Integration Failures

This webinar focuses on a risk-based approach to validating data transfers and system integrations. It examines interface requirements, data mapping, transformation rules, error handling, reconciliation, monitoring, audit trails, and end-to-end data integrity. Practical attention is given to APIs, middleware, event-driven integrations, batch transfers, and integration failures that may remain invisible when testing focuses only on individual applications. Modern GxP environments rarely consist of isolated applications. Critical quality and manufacturing processes depend on interfaces between laboratory systems, MES, ERP, LIMS, QMS, data platforms, cloud services, APIs, and middleware. A failure in an interface can create incomplete, duplicated, delayed, transformed, or incorrect data even when the individual systems are validated.

Interface failures are often underestimated because validation activities are organized around applications rather than end-to-end processes and data flows. Yet a validated source system and a validated target system do not automatically demonstrate that the data exchanged between them remains complete, accurate, consistent, and attributable. Participants will gain a practical framework for determining the GxP impact of interfaces and for designing proportionate verification and testing. The webinar will help organizations identify critical data paths, define meaningful interface requirements, challenge assumptions about successful transfers, and test failure scenarios rather than only nominal processing. It also addresses how to establish evidence for monitoring, reconciliation, exception handling, and ongoing assurance. This approach supports both robust data integrity and more effective investigation of integration-related deviations.