This document describes the OQ/PV services for Agilent ChemStation software, including safety, communication, and internal testing. These services use a written protocol and software qualification procedure to ensure that Agilent ChemStation operates within pre-defined limits, can handle any safety issues, and reports chromatograph results accurately. These services are also available for systems configured solely for data analysis, such as Agilent networked solutions. All tests are fully documented. The documentation attests to the software's compliance with test specifications and can be used as support for FDA 21 CFR Part II certification.
The guide details the procedure for qualifying the Agilent ChemStation software, covering safety checks, communication verification with instruments, and internal system tests. These services are designed to ensure the software operates within predefined limits and can handle security issues accurately.
The document specifies supported hardware modules, including single-instrument and additional modules for LC, GC, CE, and A/D analysis, as well as data evaluation modules. It describes specific test categories such as communication checks between software and instruments, security access management, and internal functional integrity verifications. This manual is written in Italian.
| Supported Software Version | ChemStation versione A.06.01 e successive |
|---|---|
| FDA Compliance Support | 21 CFR Parte II |
To ensure the software functions within predefined limits and reports chromatographic results accurately.
Yes, they are also available for systems configured solely for data analysis, such as Agilent network solutions.