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.

| LEARNING OBJECTIVES

• Identify GxP-relevant interfaces and determine their criticality using a risk-based approach.
• Define interface requirements covering data content, mapping, transformation, timing, and error handling.
• Understand validation considerations for APIs, middleware, file transfers, and event-driven integrations.
• Design tests for normal processing, boundary conditions, failures, retries, duplicates, and missing data.
• Evaluate reconciliation, monitoring, audit trail, and exception-management controls.
• Assess end-to-end data integrity across interconnected GxP systems.

| AREAS COVERED

• Why interface validation is different from application validation
• Mapping GxP data flows and identifying critical interfaces
• Interface requirements: source, target, mapping, transformation, timing, and sequencing
• APIs, middleware, file transfers, and event-driven architectures
• Testing data integrity and end-to-end process behavior
• Integration failure modes: missing, duplicated, delayed, corrupted, or transformed data
• Error handling, retries, reconciliation, monitoring, and alerting
• Change control and ongoing assurance for interfaces
• Practical examples of interface validation strategies

| WHO SHOULD ATTEND

• Quality Assurance Departments
• CSV / CSA Professionals
• IT Quality, IT Compliance, and GxP IT professionals
• System Owners and Process Owners
• Data Integrity and Data Governance Professionals
• IT Architects and Integration
• API specialists supporting GxP environments
• Engineering, Automation, and Digital Manufacturing professionals