21 CFR Part 11 Software Privilege Groups — ICP Expert II

The 21 CFR 11 privilege groups and the actions that members of each privilege group can perform are outlined below. A tick indicates that the group can perform
the operation. Some privilege groups work only in combination with one or more other group(s). See the notes following the table.

Sequence Operation

Adjust Preferences

Add Comments to
Sequence Editing

Instrument Tests
Torch Alignment

Approval level 1

Approval level 2

View Audit Trail

Worksheet Run

SCM Event Log

Plasma Control

Results Editing
Method Editing

Polychromator
Adjust Ignition

Report/Export
Echelle Work

(Authorizing)
Diagnostics
Wavelength

Parameters
Action

Calibration

Sequence

Service

Align
Instrument actions

Alter Wavelength Calibration page   

Alter Ignition page   

Alter Echelle page   

Alter Torch Align page   

Alter Autosampler page                    

Auto-update Log page                    

Alter Quick Diagnostics page 

Alter Gasbox Diagnostics page 

Alter Optics Diagnostics page 

Alter RF Diagnostics page

Align the Polychromator 

Create Instrument test worksheets 

 Sequence Operation

Adjust Preferences

Add Comments to
Sequence Editing

Instrument Tests
Torch Alignment

Approval level 1

Approval level 2

View Audit Trail

Worksheet Run

SCM Event Log

Plasma Control

Results Editing
Method Editing
Adjust Ignition

Report/Export
Echelle Work

(Authorizing)
Diagnostics
Wavelength

Parameters
Action

Calibration

Sequence

Service
File management

Create new worksheet                    

Save worksheet                    

Copy (as worksheet)                    

Copy (as template)                    

Create new worksheet from template                    
Open own worksheets                    

Open others’ worksheets                    

Print Setup 

Print 

Print Preview 

Report settings 

Export 

Export settings 

Editing

Copy 

Copy special 

Delete results
 Sequence Operation

Adjust Preferences

Add Comments to
Sequence Editing

Instrument Tests
Torch Alignment

Approval level 1

Approval level 2

View Audit Trail

Worksheet Run

SCM Event Log

Plasma Control

Results Editing
Method Editing
Adjust Ignition

Report/Export
Echelle Work

(Authorizing)
Diagnostics
Wavelength

Parameters
Action

Calibration

Sequence

Service
Method Editor

Select analysis lines (Element page) 

Select internal standards (Element page) 

Set sample uptake delay (Conditions page) 

Set stabilization delay (Conditions page) 

Set pump rate (Conditions page) 

Select fast pump (Conditions page) 

Set rinse time (Conditions page) 

Set SmartRinse (Conditions page) 

Define calibration (Standards page) 

Set standard additions (Standards page) 

Set Reslope (Standards page) 

Set standard units (Standards page) 

Edit IEC solutions (IEC page) 

Edit QCP solutions (QC Test page) 

Subtract Prep Blank (Edit QC Test Definition dialog box) 

Activate background correction (Corrections dialog box) 

Set points per peak (Corrections dialog box) 

Activate FACT (Corrections dialog box) 

Activate AutoMax 

Activate SRS 
 Sequence Operation

Adjust Preferences

Add Comments to
Sequence Editing

Instrument Tests
Torch Alignment

Approval level 1

Approval level 2

View Audit Trail

Worksheet Run

SCM Event Log

Plasma Control

Results Editing
Method Editing
Adjust Ignition

Report/Export
Echelle Work

(Authorizing)
Diagnostics
Wavelength

Parameters
Action

Calibration

Sequence

Service
Sequence

Change number of samples  

Change sample labels  

Import/export sample labels  

Change weight, volume & dilution factor  

Modify all Sequence Editor options 

Select sample source 

Change Sequence Parameters 1

Analysis

Turn plasma on 

Run worksheet 

Edit replicate values 

Change Column Properties 

Change Column units 

Use as correction  2
2

Perform a Wavelength Trim 2 2

Edit IEC factors 

Filter operations log                    

Track worksheet (operations log)                    

Security actions

View Permissions                    

Sign a worksheet                    

Authorize 

View audit trails 

Add comment to SCM Event Log 

Lock ICP Expert                    

1
The ‘Sequence Parameters’ privilege provides access to all sequence parameters with the exception of ‘End of sequence’. If the ‘End of sequence’ is required,
the user must also be a member of the ‘Plasma Control’ privilege group.
2
In order to edit the results associated with this action, the user must also be a member of the ‘Method Editing’ privilege group. The ‘Method Editing’ privilege is
required to access the functionality, and the ‘Results Editing’ privilege is required to retrospectively edit the functionality.

Agilent Field Service Engineer Privileges

Agilent field service engineers need to be assigned to the following Privilege groups, to give them limited access to the system so they can run the instrument
during servicing:
 Wavelength Calibration
 Torch Alignment
 Diagnostics
 Plasma Control
 Worksheet Run
 Method Editing
 Sequence Editing
 Results Editing
 Report/Export
 Authorizing*
 Instrument tests
 Service
 Polychromator Align

* There is a step during servicing, involving setting the nebulizer flow/pressure, which needs to be authorized. Either the operator will need to be an authorizer, or
another person with authorizer privileges will need to authorize the changes before the field service engineer can proceed.