Validation Manager®
The quick and reliable way to validate
analytical methods
When operating according to quality management systems (e.g. according to GMP,
GLP or ISO guidelines), validation of the procedures used is of the utmost
importance. However, this process including the compilation of the validation
report is often tedious and time-consuming. The Validation Manager is a
valuable, time-saving aid, that checks whether your analytical methods are
suitable for the intended use and automatically produces the validation report
you need.
Universally
accepted
Validation Manager is based on the international guidelines for
validation of analytical methods as established by EP, USP, FDA, ICH and ISO.
Versatile configuration for all analytical techniques
The validation procedure can be configured with regard to
formats, used terms and language as well as with regard to calculation methods
and statistical tests to be applied. Several pre-configured templates can be
selected. New templates can be created and stored. This high degree of
versatility enables the Validation Manager to be used for the validation of
practically all analytical procedures.
easy operation
Validation Manager is extremely simple to use. Only a few questions
must be answered in a wizard dialogue, then the validation project and document
is created with a push of a button.
easy creation of sample preparation worksheets and injection tables
Another programming assistant helps to create sample
preparation worksheets for the different method characteristics to be assessed.
In addition even injection tables for the EZChrom EliteÒ
chromatography data system can be created automatically.
easy data entry
After data acquisition chromatography data can be imported
from the chromatography data systems EZChrom Elite®
, D-7000 HPLC System Manager and Agilent ChemStationÒ. Moreover,
any data can be copied from EXCEL tables or input manually.
automatic calculation
After data entry the required method
characteristics are automatically calculated and statistically checked according
to the configured procedures.
automatic report compilation
After entering your comments and decisions, the entire method
validation report is created - with only a mouse click.
validated and fully FDA 21CFR part 11 compliant
Validation Manager Software is validated and the
validation certificate is included in the software package. It contains all
functions to make it fully FDA compliant.
substantially time-saving
As a comprehensive tool for computer-assisted method
validation Validation Manager supports the user in the different steps of the
validation procedure. Substantial time savings can be realised especially by the
automatic compilation of the validation report.
Validation Manager - the time and cost saving tool for
validation of analytical methods can save days or even weeks of work.
If you have the need to validate analytical methods please contact our
specialists and learn more about Validation Manager software.
ValidationManager® - more information
