This document introduces the OQ/PV procedures for Agilent ChemStation software, including security, communication and internal verification tests.
This manual outlines the operational qualification (OQ) and performance verification (PV) procedures specifically designed for Agilent ChemStation software. These services utilize written protocols and software qualification steps to verify that the software operates within pre-defined acceptance limits.
The document covers various supported software modules, including LC, GC, CE, A/D converter, and data evaluation tools. The tests interactively determine correct communication between the software and analytical instruments, challenge security logons, and verify the structural integrity of data analysis components.
| Software Version Requirement | A.06.01 and later |
|---|---|
| Supported Modules | LC, GC, CE, A/D converter, Data Evaluation |
| Regulatory Standard | FDA 21 CFR Part 11 |
These services use a written protocol and software qualification procedure to ensure that Agilent ChemStation software operates within pre-defined acceptance limits.
No, the communication test determines correct communication between the software and the instrument but does not perform an OQ/PV on the analytical instrument itself.
The tests have been designed using devices traceable to national standards such as NIST and NAMAS.