Specifications

input grids. The following defini-
tions can be made:
• name and description of the
import mask,
• source type (file extension) and
path,
• field separator (delimiter),
• row options,
• data positions (with optional
transposition of the data) allow-
ing to exclude header and text
data,and
• column information (X-Y data,
information for multiple injec-
tions and determinations).
The import settings can be saved
and applied at any later time to
import data. The system can han-
dle multiple data import masks
allowing to quickly import results
from various data sources.
Level 1: Reporting
Method Validation Pack software
offers multiple reports. Users can
have
• planning reports–print all
data from the planning dialog,
• graphics report for each
checkpoint–prints only results
in graphic representation,
• complete reports on check-
point level, component level,
and
• complete validation reports
with all validation settings and
all component and checkpoint
results.
The validation report includes the
following parts:
• Page header and page
footer (Footer includes printed
user name, date, page # of # and
a signature placeholder for
manual report sign-off.)
• Report title page
• Default comment page
• Table of contents with page
numbers
• Checkpoint sections for each
checkpoint consisting of head-
er data, planning comment,
measurement results, graphics
and statistical results, execu-
tion comment and revision
information from the document
management system.
Report customization
Method Validation Pack uses a
Microsoft-Word-based reporting
engine. It allows to open the
entire method validation report as
a MS Word document. This allows
for easy data export of the com-
plete validation report and easy
modification and customization of
the report document. In addition
to the customization in MS Word,
the following elements are config-
ured within the Method Validation
Pack application:
• report language: German or
English,
• report fonts and sizes,
• graphics section: line style,
background color for data,
color of axis and display of
limits, axis annotations, and
• text sections: title page,
validation comment page,
report header and default
planning and execution
comment. All text sections can
also include graphics such as
company logos.
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Level 2: Data input
After checkpoint configuration
and planning is completed, users
can now start data entry. This is
the first result related step.
Method Validation Pack offers
three types of data input:
1. Automated data upload from
the ChemStore database. Users
select to load study data from
the ChemStore method valida-
tion study and all data are
automatically imported as con-
figured in the Method Validation
Pack Planning and described in
the previous section
2. Data import for all result data
that is not created and managed
in the ChemStore database e.g.
data from non-Agilent instru-
ments during robustness
testing. The system comes with
an import filter allowing to
automate data import. For
details see the separate section
data import
3. Manual data entry - for all data
that are not created on a
computer system, e.g. pH
values, the system allows
manual data entry
Data import
Data import uses an import assis-
tant, which offers you data trans-
fer from external result files typi-
cally in spreadsheet formats. It
imports file formats in CSV, TXT
ASCII format and any other for-
mat that is manually entered. The
import assistant displays a defini-
tion dialog enabling Method
Validation Pack to automatically
load this summary data to its data