Streaming Course

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

Course Information

Course Type: Streaming Course
Course ID: LSP1332
Format: Streaming
Duration: 90 Minutes
Presenter: Milan Kučera

Registration Options

Format: Streaming
Duration: 90 Minutes

Streaming (Per Attendee): USD 290.00

About the Course

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.

Key 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

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.

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

Presenter

Milan Kučera

Milan Kučera is a senior validation and GxP technology professional focused on computerized systems, laboratory systems, data integrity, cloud environments, and emerging technologies in regulated organizations. His work combines practical validation and compliance expertise with a strong focus on risk-based approaches, quality strategy, and inspection readiness. He has a particular interest in the application of modern technologies, including cloud computing and AI, within regulated GxP environments — with emphasis on governance, data integrity, validation strategy, lifecycle management, and effective human oversight. His approach is to translate complex regulatory and technological expectations into practical controls, evidence, and implementation strategies.