A risk-based approach to validating data transfers and system integrations — interface requirements, data mapping, transformation rules, error handling, reconciliation, monitoring, and end-to-end data integrity.
Includes live access & recording
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.
By the end of this session, participants will be equipped to validate GxP interfaces with a risk-based, end-to-end approach.
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.
Focused areas that will strengthen how your organization validates interfaces between GxP systems.
Understand why interface validation demands a different lens than validating each connected application on its own.
Apply validation considerations specific to APIs, middleware, batch transfers, and event-driven architectures.
Test for missing, duplicated, delayed, corrupted, or transformed data — not just nominal, successful transfers.
Establish evidence for ongoing monitoring, reconciliation, and exception handling that supports data integrity over time.
A comprehensive look at validating data transfers, APIs, middleware, and end-to-end integrity across interconnected GxP systems.
Professionals across quality, IT, and engineering functions responsible for validating interfaces between GxP systems.
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 Specialists
API Specialists Supporting GxP Environments
Engineering, Automation, and Digital Manufacturing Professionals
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. 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 — the interface itself requires its own risk-based verification and testing.
A practical framework for determining GxP impact helps organizations identify critical data paths, define meaningful interface requirements, challenge assumptions about successful transfers, and test failure scenarios rather than only nominal processing — establishing the monitoring, reconciliation, and exception-handling evidence needed for both data integrity and effective investigation of integration-related deviations.
Don't miss this essential training on validating data transfers, APIs, and middleware between GxP systems. Secure your spot now.