Specifications

Agilent ChemStation Plus Method Validation Pack — Interaction with ChemStore
database
• Save raw data with results
• Delete raw data on the local
hard disk after transfer to the
database
• Save method and sequence
along with results
• Save chromatogram and spectra
pictures with the result
In a 21 CFR Part 11 validation, all
checkmarks are set to true for the
data management options as men-
tioned before.
component in the validation -
comparable to the ChemStation
Plus compound.
• MV_runID - storing a unique
run identifier that allows full
traceability from method vali-
dation pack results to
ChemStation Plus result man-
agement. This is particularly
useful for example, if you noti-
fy outliers in your method vali-
dation. In order to check
and/or reanalyze this run, you
only have to query for the run-
ID to immediately receive the
run with its result that is under
investigation.
Interaction with ChemStation
for data review
For a first pass review of the data
the ChemStation batch review
interface can be used. If required
the user can do a graphical
rework of a chromatogram and
generate a new result version that
is used for the validation. The
result is transferred to the data-
base and the change is document-
ed in the run-related audit trail.
The user decides if the validation
is a development validation or a
final validation that must run
under full 21 CFR Part 11 condi-
tions. In the former case, users
with administrative rights can
configure the ChemStore study in
Method Validation Pack similar to
the study configuration in
ChemStore. They can select to
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ChemStore manages the analytical
results along with the raw and
meta data of the samples in a rela-
tional database. This also includes
all analytical data of the method
validation sequences that have
been acquired in ChemStation.
The method validation data are
stored in method validation stud-
ies. Method validation studies are
similar to standard ChemStore
studies except that they can only
be created and modified through
the Method Validation Pack soft-
ware. All method validation study
data are visible in ChemStore, but
they can not be changed or modi-
fied except for reanalysis. As part
of the data transfer from Method
Validation Pack to ChemStation,
the Method Validation Pack soft-
ware creates a method validation
study in ChemStore. The study
name is the validation name.
Method Validation studies have
three custom fields automatically
configured with the studies. These
fields are
• MV_checkpoint - storing the
Method Validation Pack check
point information (which test
was used with this run)
• MV-Component - the name of
the Method Validation Pack
tor only fills in the vial position
for the samples and starts the
sequence. For further details on
ChemStation functionality, please
refer to ChemStation specifica-
tions, Agilent Technologies publi-
cation number 5988-5314EN.