How to Validate a GPC/SEC System

March 23, 2010

The Column

Volume 6, Issue 4

Validation is not an easy task. It is an ongoing complex process that evaluates the entire, sample specific process, products and analytical methods.

Validation is not an easy task. It is an ongoing complex process that evaluates the entire, sample specific process, products and analytical methods and consists of four qualification phases: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification/Performance Verification (OQ/PV) and Performance Qualification (PQ).

Before the first sample is analysed, users have to verify and document that the system meets the user requirement specifications, is correctly installed and working according to the manufacturer’s specifications in the selected environment.

Validation of the system is complete after the instrument hardware, software, data, analytical method and operators are factored in the process. In addition to simple performance tests for each isolated component, it is essential to confirm that the complete system works according to the performance specifications of the analysis method (holistic approach). Here it is important to take the specific requirements of the applied method into account. This ensures that all critical parameters influencing the results are identified and properly monitored over the system’s life cycle.

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