BUCHI NIRWare User Manual

Page 4

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Contents

NIRWare 1.5 Software Manual

5.5.1.

Development of an application for Content Uniformity Testing

(CUT) of Solid Dosage Forms .................................................................. 90

5.6.

Using applications and calibrations in Life Cycle state "Created" ......... 102

5.6.1.

Application for development (Life Cycle state "Created") ......... 102

5.6.2.

Application in routine use (Life Cycle state 'Approved') ............ 104

5.7.

Importing license protected applications (e.g. BUCHI or Ingot Pre-

Calibrated Applications) ...................................................................................... 105

5.8.

Measuring an SST ................................................................................. 106

5.8.1.

Manual SST measurement ....................................................... 107

5.8.2.

Automatic SST measurement ................................................... 107

5.9.

Measuring a NADIA ............................................................................... 107

5.10.

Measuring a reference ........................................................................... 109

5.10.1.

Internal / External Reference .................................................. 109

5.11.

Carrying out a measurement with the Operator..................................... 110

5.12.

Extended Wavelength Range ................................................................ 125

5.12.1.

How to Setup NIRWare for the Extended Range ................... 125

5.12.2.

Limitations, Risks and Warnings ............................................. 128

6.

NIRWare Suite

131

6.1.

NIRWare Management Console ............................................................ 131

6.1.1.

Management Console ............................................................... 131

6.1.2.

Filter .......................................................................................... 134

6.2.

Application Designer .............................................................................. 137

6.2.1.

Introduction Application Designer ............................................. 137

6.2.2.

Comparing external reference spectra and defining the tolerance

limit

142

6.2.3.

Parameter list ............................................................................ 143

6.2.4.

Assigning a property ................................................................. 143

6.2.5.

Calculated property ................................................................... 147

6.2.6.

Property settings ....................................................................... 153

6.2.7.

Definition of calibration range, warning and action limits .......... 157

6.2.8.

Bias and Slope calculation ........................................................ 158

6.2.9.

Instrument parameters .............................................................. 162

6.2.10.

Measurement cell specific settings ......................................... 168

6.2.11.

Report parameters .................................................................. 169

6.2.12.

Operator configuration parameters ......................................... 171

6.2.13.

Bar code configuration ............................................................ 175

6.2.14.

Settings for LIMS .................................................................... 177

6.2.15.

Cyclic Measurement configuration .......................................... 178

6.3.

Sample Management ............................................................................. 184

6.3.1.

Introduction Sample Manager ................................................... 184

6.3.2.

Batches ..................................................................................... 186

6.3.3.

Properties .................................................................................. 189

6.3.4.

Samples .................................................................................... 193

6.3.5.

Measurements .......................................................................... 201

6.3.6.

Reports overview ...................................................................... 212

6.4.

Administrative Tools ............................................................................... 216

6.4.1.

Introduction Administrative Tools .............................................. 216

6.4.2.

System Logger .......................................................................... 217

6.4.3.

Lifecycle Templates .................................................................. 219

6.4.4.

NIRWare Configuration ............................................................. 222

6.4.5.

Database Maintenance ............................................................. 223

6.4.6.

Customer Information Configuration ......................................... 233

6.4.7.

Import / Export .......................................................................... 234

6.5.

Security Designer ................................................................................... 251

6.5.1.

Introduction Security Designer .................................................. 251

6.5.2.

Users and Groups ..................................................................... 252

6.5.3.

Security Policies ........................................................................ 262

6.6.

LIMS Interface ........................................................................................ 266

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