Specifications

missing values either as Zero or
as MV in case the configuration
allows 0 as valid data input)
• Multiple injection and
multiple determination of
data point.
Multiple injections uses repeti-
tive injections from the same
vial and averages the results
before applying statistics; the
number can be between 2 and
10. Multiple determinations
allows using data from two dif-
ferent vials for the same check-
point. Number of multiple
determinations allows for val-
ues from 2 to 10
• Method Validation Pack –
Planning
Configures the data type that is
imported from the ChemStore
database as result value plus
additional header information
that is imported from
ChemStore along with the
result values. Available result
values are peak area, peak
height, peak width, retention
time, and amount. Additional
header information can be:
• method name and method
text,
• instrument name,
• instrument module with
serial numbers,
• run Ids (database Ids),
• run Ids and approval status,
• run Ids and raw data file
path, and
• all custom fields with data
entries.
The system allows a maximum of
5 additional header items.
42
• Robustness
• Lab capability ( mainly used in
non-pharmaceutical applica-
tions)
• Calibration function
• Limit of detection/quantification
• Accuracy
• Selectivity
• Ring experiment (used to com-
pare results among multiple lab-
oratories)
• Linearity
The checkpoint configuration will
typically depend on the compound
type, and hardly any component
requires execution of all check-
points. The system therefore
requires running the checkpoint
configuration for each component
individually.
Level 3: Checkpoint planning
Each checkpoint must be config-
ured. The configuration defines
the test and calculation methods,
data sources and data types for x-
and y values (e.g. for linearity x-
value is amount in mg/mL and the
y-value is peak height). The fol-
lowing sections are configurable
for all checkpoints:
• Checkpoint headers
Data sections will show default
data if configured in the valida-
tion properties and allow indi-
vidual data entry for each head-
er line
• Test planning data
Selects the calculation method
from a pool of possible calcula-
tions used for this checkpoint
• Number of result values and
y-unit
Defines the number of samples
used for calculations (Note: By
default, minimum number must
be six and the system will show
Figure 26
Checkpoint planning window (example for accuracy) with sections for check-
point header data, test planning data, number of results y-units and multiple
determination.