Hplc Software Validation Protocol. First the pump then the detector then the computer with HPLC software. 33 Manager Designee from Analytical Research Department.
Revalidation is necessary whenever a method is changed and the new parameter is outside the operating range. Integrated software and optics. To review the Software Validation Protocol and Software Validation Report.
Switch on the HPLC system.
The simplest form of an HPLC system suitability test involves a comparison of the chromatogram trace with a standard trace as shown below. Demonstrate the separation of the analyte from Placebo. HPLC METHOD DEVELOPMENT AND VALIDATION. This software validation is limited to HPLC system its unique components and control system that defines the hardware and software.