Technical data

28 Understanding Your Agilent ChemStation
1 Agilent ChemStation Features
About the ChemStation Software
Good Laboratory Practice
The ChemStation is developed to internationally recognized design and
development standards and has a number of features specifically to help users
operating in a regulated environment. These features are in the area of
complete method specification and verification that the methods are fit for
their intended use, to check the operation of their system and ensure the
traceability, originality and quality of the data.
Development Process
The Certificate of Validation shipped with each software package documents
the software development and testing steps executed as part of the
development cycle. The development process is registered to the ISO 9001
quality standard. It is documented together with onsite revalidation protocols
in the Validation BinderAgilent ChemStation for LC.
Method Specification and Use
• Global methods — the complete instrument and data analysis specification
is stored in one place. Methods include individual compound range
specifications to check that quantification results are not applied outside
the calibrated range.
• The method change history log allows users of a validated method to
automatically record how and when a method was changed. Users may
optionally add a comment reason to the change history log. The change
history log is automatically stored as part of the method in a binary format.
To prevent unauthorized access to the records, it is protected by the user
access scheme, described below. The change history log may be viewed and
printed.
• Limits may be assigned on a compound-by-compound basis in each method
for a number of chromatographic/electropherographic and system
performance parameters, as described in the data analysis quantification
section. Results exceeding these parameter ranges are used to control the
execution of automated sequences as described in the automation section.
They are indicated on the appropriate analysis report.
• System performance or suitability reports (see the Reporting section above)
provide detailed analysis of the separation quality.