Specifications

From planning to execution
3)Experiment setup and data
management configuration
(Level 3)
a) Creation or update of
ChemStore study for all Method
Validation Pack analytical
result data
b) Automated system gen-
erated creation of ChemStation
method validation sequence
based on the validation
configuration and
c) Transfer of the sequence to
the ChemStation analytical
system for data acquisition and
first pass analysis
After data acquisition
4)Data entry and result
calculation (Level 2)
a) Data storage in Chem-
Store database method valida-
tion study and
b) Data upload by database
transfer to Method Validation
Pack application
5)Method validation report-
ing (Level 1)
After data completion, creation
of method validation report
document with result calcula-
tion and statistics
Figure 24 illustrates all data trans-
fer steps. All configuration and
transfer steps are fully automated
and are integrated in the
ChemStation Plus software. All
export and import jobs are docu-
mented in audit trails avoiding
any accidental transfer or tran-
scription error.
39
All tasks are managed within the
ChemStation Plus system. All
ChemStation Plus modules support
data security, data integrity and
audit-trails for comprehensive sup-
port of FDA's requirements of elec-
tronic records and electronic signa-
tures. The combinations of audit-
trails in all ChemStation Plus mod-
ules with advanced database data
security offers full traceability and
complete documentation of all steps
during user's method validation
experiments.
Method Validation Pack
hierarchy
The Method Validation Pack soft-
ware structure is strictly hierarchical
with 5 levels. These levels also corre-
spond to user-access levels. The list
below outlines the step-by-step exe-
cution of the method validation
experiments with the hierarchical
structure and the user access levels.
Prior to test execution
1) Setup and configuration
(Levels 5 and 4)
Validation planning and
component configuration in the
Method Validation Pack
software
2) Checkpoint planning (Level 3)
Each checkpoint can use different
calculation techniques depending
on the various guidelines. The
checkpoint configuration step is
either repeated for each check-
point or it is copied from another
component using drag and drop
functionality.
Figure 24
Interaction of ChemStation Plus software modules and their mapping of the
key steps of method validation experiments