12
12. . GLP Functions
GLP Functions
726 Titroprocessor, Short Introduction
49
49
Select a storage location (Internal or Data card) and a stored method. You
can use the <Space> key or the [Select] softkey for opening a picklist to
choose from. Add a comment and modify the limits for the validation results.
12.8 The Limits and their Meanings
The validation results will provide you with a reliable assessment of the ac-
curacy and reproducibility of the titration system including dosing drives and
sample changer.
Mean value
The mean value of all determination results (RT1) of the
validation series. At least 10 determinations should be
performed. We recommend titer determinations as vali-
dation methods.
Default limits 0.995…1.005
Standard deviation absolute
Absolute standard deviation of the results (RT1) of the
validation series.
Default limit ± 0.003 (for titer determinations)
Standard deviation relative
Relative standard deviation in percent.
Default limit ± 0.3 %
Systematic deviation d(rel)
Systematic deviation of the mean resultat vs. theoretical
result (RT2).
dd
rel
rel
=
−
result
result
result
*100
mean
theo
theo
Default limit ± 0.1 %
Systematic error
(a
sys
)
Systematic error due to disturbing influences such as
solvent blank values or method-inherent imperfections.
It is determined by the intercept of the linear regression
of the endpoint volumes (RE) vs. sample sizes (SS).
Default limit ± 0.010 mL
Validation interval
Time interval for the expiration of the validation. When a
validation has expired a message will appear at each
startup of the Titroprocessor.
Default limit ‘
12 month(s)'
Sample size
a
sys
