Specifications

Output settings
The method validation output set-
tings define contents of the
checkpoint calculations and the
report content for each check-
point. For details on the check-
point content, please see the
checkpoint section later. Output
settings also define overall report
configuration items for text and
graphics section and the docu-
mentation of configuration values
in the report.
Text output settings define:
• the report title page,
• an additional general report
comment page,
• the report header and,
• default comments for
validation planning and
validation configuration
In addition, the text configuration
defines the checkpoint table head-
ers (such as method name, instru-
ment type etc). Each checkpoint
can have up to ten header data
lines with different content. The
header information is used to
describe general validation infor-
mation that is necessary to
uniquely identify and characterize
the method validation experi-
ment. Examples for useful table
header are the product name, the
analytical equipment, QS or inter-
nal ID number, test method and
40
User levels
Top-level (Level 4 and 5):
Validation setup and configu-
ration
Setup
Method Validation Pack organizes
data in method validation databas-
es. A method validation database
is the top-level container for all
data that relate to one validation.
All settings are linked to one vali-
dation database. For new valida-
tion files the software offers a
master validation template that
allows building new validations on
the template. The following set-
tings or properties are configured
for each validation:
• validation configuration,
• output settings,
• default reporting header data,
• storage of external documents
and,
• storage of method in text
format.
Validation configuration
Validation configuration defines
the statistical calculations in the
report. Each checkpoint offers dif-
ferent calculation options and is
configured individually. In addi-
tion, the configuration task
defines overall calculations that
are common for all checkpoints.
These are outlier tests, trend test,
homogeneity tests and systematic
error detection calculations. Other
settings allow specifying the stan-
dard sample number for each test,
handling of 0 as input and han-
dling of missing values. For non-
Part 11 validations, you can speci-
fy the audit-level in the configura-
tion as well.
Figure 25
Validation properties menu for validation setup and configuration