BUCHI NIRWare - Manual (Page 10)

4

Introduction NIRWare 1.5 Software Manual
2.1. NIRWare Management Console
NIRWare Management Console is related to Microsoft Management Console (MMC). It hosts all Snap-In
Modules of the NIRWare Suite except NIRWare Operator. The Management Console can be configured
for different Users or User Groups. Closely linked to the NIRWare Software Suite is the NIRCal
Chemometric Software.
2.1.1. Application Designer
The design of an application predominantly defines how the operator has to perform a specific analysis. It
includes the definition of instrument configuration and instrument parameters and the definition of the
required inputs (Batch number, sample name,...), the properties to estimate, the calibrations to be used,
the Standard Operating Procedure (SOP) displayed in order to guide the operator and finally to select the
report to be displayed.
The Application Designer is very flexible to customize a specific application. For easy use the basic mode
is available in which only a few entries are necessary to develop an application. For the advanced user
many options and features are available. Different report templates are available for qualitative and
quantitative applications.
2.1.2. Sample Management
NIRWare Sample Manager is designed to check previous measurement results and to enter reference
values.
The main concept of NIRWare Sample Manager is a software interface allowing to:

Manage Samples (assign reference values and properties to the sample)

Manage and Print-out results of previous measured samples and system tests

sign results electronically

Manage Properties (create and design properties)
For further details see section: Introduction Sample Manager
2.1.3. Administrative Tools
The entire software is database-oriented. In NIR spectroscopy, vast data volumes are processed. It must
be possible to manage these data easily. The NIRWare Administrative Tools allow backups and updates
to be made.
Audit Trail / System Logger
All relevant operations within all software modules, applications and calibrations are stored in the
Audit Trail. With this tool all changes are traceable. Other log functions for the system and errors
are also part of this tool.
The Audit Trail is a required part of FDA’s 21 CFR Part 11 regulations.
Different filter functions are also available to select the requested entry.