A Risk Based Approach to Compliant GxP Computerized Systems.
If you haven’t read part 3 “Design and Configuration” click here to read now!
Validation and Testing
Validation Plan:
“The adage ‘Measure twice, cut once” emphasizes the importance of meticulous planning, particularly in construction and other projects. A robust Validation Plan is crucial, outlining the strategy, scope, and timeline for requirements, and clearly assigning responsibilities. Compliance with GAMP® 5 guidelines and regulatory standards forms the basis for successful system validation. This plan details the necessary level of rigor and documentation for validation, and specifies which organizational roles are responsible for each activity.
Installation Qualification (IQ):
GAMP® 5 Second Edition provides guidance on establishing a robust foundation for your system, including all related hardware and software interdependencies. A solid, stable, and compliant foundation is essential; without it, the system risks failure. Installation Qualification (IQ) is a crucial first step, ensuring that the infrastructure meets regulatory standards, the network is stable and reliable, and appropriate contingency plans are in place. This makes IQ a vital element in the system lifecycle. Whether you host your environment onsite or use an Infrastructure as a Service (IaaS) provider, GAMP® 5 Second Edition offers essential guidance to ensure your organization complies with regulations and builds or acquires the necessary infrastructure. Additionally, it’s important to qualify the infrastructure platform. This process, similar to application validation, focuses on ensuring that the infrastructure functions effectively and maintains sustainable controls.
Operational Qualification (OQ):
Now that the infrastructure is in place and qualified, it’s crucial to perform the Operational Qualification (OQ), which is the second phase of the infrastructure qualification process. This step verifies that the infrastructure can withstand the demands of daily use. During the OQ, the environment and its components are rigorously tested to ensure they function effectively according to both the vendor’s specifications and regulatory standards. This includes confirming that all elements operate within the manufacturer’s approved ranges, guaranteeing the system performs as intended.
Performance Qualification (PQ):
GAMP® 5 Second Edition now completes the qualification process by presenting evidence that the system fulfills all previously identified lifecycle requirements, as detailed in the functional specifications. The Performance Qualification (PQ) process assures the organization with absolute confidence that the system meets all initial requirements. The system is now prepared for testing to verify its consistent and reliable performance under normal and enhanced stress conditions.
User Acceptance Testing (UAT):
UAT is a crucial phase in the system development lifecycle, serving as key evidence for regulatory compliance. It verifies that the system performs according to the user requirements specified earlier in the development process. The guidance provided by GAMP® 5 Second Edition helps determine the appropriate level of rigor and documentation required for system testing, which varies based on the risk assessment outcomes. This ensures that the documentation effort is proportionate to the system’s risk level.
