Specifications

repetitive injections in order to
use statistics for a quantitative
result evaluation. The statistical
results display whether the results
meet their specifications or if
there is any deviation. When all
tests are passed, the compound
meets the requirements. When all
compounds meet the requirements
the method can be seen as applic-
able or "validated" according to its
well-defined purpose. At this
stage, the validation can be
locked, the full validation is print-
ed and the validation database for
this method can be archived.
Method Validation Pack provides
all required statistical calcula-
tions, stores all results with their
raw and meta data, displays the
statistics graphically, and captures
all actions in user-independent
audit-trails. Further, it allows to
map the key steps in validation
experiments - planning and defini-
tion of expected results, experi-
ment execution and result evalua-
tion - as separate tasks. All steps
are documented in audit-trails and
are fully traceable.
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Product description
Agilent ChemStation Plus Method
Validation Pack is a data manage-
ment system for all method valida-
tion data. It includes advanced sta-
tistical calculations and result
management in a relational data-
base.
Method Validation Pack offers a
compound-centric design. For
each compound it allows to define
a set of tests (checkpoints)
according to ICH, Pharmacopoeia
or DIN guidelines. By default each
test requires results of at least six
Agilent ChemStation Plus Method Validation Pack—Work Flow
Configuration
The configuration of validation
experiments is hierarchical. The
top level represents the complete
validation experiment, including
the method in text form, calcula-
tion documentation and SOP file
documents. The next level intro-
duces a compound-centric view of
the validation in the form of com-
ponents. This enables individual
calculations and validations for
each compound or peak in an ana-
lytical separation. For each com-
ponent, additional sub-levels offer
a list of checkpoints such as
robustness, linearity and others as
defined in the various regulation
guidelines. The planning of check-
points is the lowest level because
each checkpoint can have a differ-
ent planning configuration. Within
the planning dialog, data is config-
ured such as the applicability of
multiple injections, multiple deter-
minations for one result data point
as well as the number of result
values and calculation tests.