System Policies and Privileges for Processing Data in Empower Software with Data Integrity in Mind

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1

System Policies and Privileges for Processing Data  

in Empower Software with Data Integrity in Mind

INTRODUCTION
With increased scrutiny around Data Integrity, it is important for Quality Units and Regulators 
to understand the Empower™ Software capabilities for processing data and the need for varied 
levels of flexibility. There is a perception that analysts may use Processing Method parameters 
or manual integration to ‘polish results’ and cause otherwise out of specification (OOS) samples 
to pass laboratory test requirements, such as assays and impurity methods. In order to fully 
ascertain what is happening in the laboratory, both the Quality Unit and Regulators should be 
fully aware of how an organization utilizes the Review window to optimize Processing Method 
parameters. This white paper will walk through the current system policies and privileges in 
Empower 3Software that effect what analysts can and cannot do when processing data,  
focusing on the use of Review.

SYSTEM POLICIES
System policies control the behavior of Empower Software for the whole application.  
They also control certain aspects of how all users accessing the system interact with the 
software. The Empower system administrator can set rules governing user accounts,  
log in procedures, full audit trail default settings, data processing techniques, result sign-off 
requirements, and date formats. System Policies help define the peak detection and integration 
techniques, and calculations that Empower uses to process data. 

There are several general data processing system policies which effect processing data:

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Calculate % deviation of point from curve – changes the formula for calculating % deviation.

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Allow Interactive System Suitability when acquiring in RUN ONLY mode – Interactive 
System Suitability, such as Stop on Fault, can be triggered when in Run Only mode.  
It is recommended to operate in the Run and Process mode so that all result(s) will  
be saved in a regulated environment.

There are also system policies which control the use of the Apex Track Algorithm:

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Allow the use of Apex Track integration – Enables the use of the Apex Track algorithm  
in the Empower database.

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Default settings used when creating new projects 

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Enable Apex Track Integration – Sets the default for new projects.

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Default Integration Algorithm – Sets the default for new Processing Methods.

Explore how Empower Chromatography Data Software System Policies 
and privileges can be used to control what users can or cannot do when 
processing data, particularly when working in the Review window

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System Policies and Privileges for Processing Data in Empower Software with Data Integrity in Mind

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There is also one critical policy which adds a control for users 
working in Review:

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Prompt user to save manual changes made in Review –  
If a user exits from Review after creating a result(s) they 
will be prompted to save the result(s). In Figure 1 the 
message reads, “Do you wish to save all modified results?” 
If users save results at this point, it will automatically save  
the last version of all results and any related changes  
(i.e. calibration curves or methods). 

Figure 1. Save results message when exiting from Review.

Any results saved in the Review window in this manner will 
automatically be labeled as manual results regardless of 
whether manual integration was used.

PROCESSING METHOD PRIVILEGE OPTIONS
Empower Software allows users to operate under a set of 
defined privileges that collectively define an overall user 
type. It is possible for an individual user to be able to log in 
with a different user type, with a different set of privileges, if 
they have to perform a specific task. Depending on the tasks 
performed, the system administrator can assign or remove 
the privileges associated with a user type. In order to properly 
validate Empower it is extremely useful to understand how 
these privileges operate and to document the privileges that 
laboratory users need to perform their work.

The privileges associated with processing methods have a 
significant effect on what users can do in the Review window:

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Lock Methods – A locked method can be used to generate 
results, however, it cannot be modified. 

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Unlock Methods – This privilege allows a user to unlock 
a method for editing purposes. This privilege should most 
likely be given to lab managers or group leaders.

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Delete Processing Methods – This privilege should only 
be granted to a high level administrator. It should be noted 
that any processing methods associated with existing 
results will not be deleted.

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Save Processing Method – Allows the user to create new 
processing methods and/or modify existing processing 
methods. This allows users to modify ALL parameters in 
any section of the processing method. It is important to 
note that the more detailed privileges described below 
have no effect if this privilege is granted (Figure 2).

If the Save Processing Method privilege is NOT granted,  
the ability to modify a processing method depends on 
whether or not any of the next three privileges are granted.  
This enables an administrator to grant access  
to only specific parameters in the processing method. 

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Modify Integration Parameters – Allows the user to 
modify peak detection and integration parameters  
on the Integration tab, such as peak width and detection 
threshold. This privilege is required for users to optimize 
integration and account for day-to-day variation in  
peak shape.

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Modify Component Times – Allows the user to modify 
the expected retention times of named peaks on the 
Components tab. This privilege is required for users to 
account for day-to-day variation in retention times and 
ensure correct peak identification.

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Modify Component Constants/Default Amounts –  
Allows the user to modify the CConst fields on the 
Components tab. This may be required to modify 
constants used to capture values such as Label Claim  
or Moisture Content, when these values periodically 
require updating. This also allows the user to modify 
existing Default Amounts.

Figure 2. Hierarchy of Processing Method privileges. The bold color indicates 

which privileges are in effect.

There are instances, when working with Impurity methods  
for example, where it becomes necessary to modify 
integration parameters and component times due to  
complex chromatography. Collectively these privileges  
allow a company to tailor a user’s ability to modify specific 
parts of the processing method.

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System Policies and Privileges for Processing Data in Empower Software with Data Integrity in Mind

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REVIEW WINDOW PRIVILEGE OPTIONS
The privileges associated with calibration and quantitation 
have a significant effect on how far through the workflow of 
processing data and generating results is possible in Review. 
These are also used to limit the calculated peak values 
viewable in Review prior to data processing.

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View Quantitation Peak Fields in Review – Allows the 
user to view the following fields in the Review window 
peaks table: Area, % Area, Height, % Height, Amount, 
% Amount, Response, and Concentration. Users not 
assigned this privilege cannot view these fields nor will 
they be visible in the properties of the peak table. 

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View Numerical and Textual Results in Review –  
Allows the user to view all numerical and textual results in 
Review. Users not assigned this privilege will only see an 
integrated 2D chromatogram. These users can perform 
batch processing or manual processing and Empower 
will recalculate the results, however, only the integrated 
chromatogram will be visible.

Figure 3. Privileges associated with actions in Review.

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Allow Calibration and Quantitation in Review –  
Allows the user to calibrate and quantitate data in the 
Review window. Users not assigned this Privilege cannot 
calibrate and quantitate data in Review. They cannot  
add, insert, delete or modify points on the calibration 
curve, individual-point table, or delete points on the 
calibration curve plot. Disallowing this privilege removes 
the ability of a user to see peak/component identification 
or any component-specific processing values in the peaks  
table or plot for any unsaved live data they are working 
with in Review (Figure 3).

There are several possible scenarios resulting from an analyst 
being assigned these privileges for working in Review.  
Here are some examples:

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Analyst has the Allow Calibration & Quantitation in  
Review privilege 

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The analyst can use the Integrate, Calibrate and 
Quantitate tools in Review.

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If the analyst has the View Numerical and Textual 
Results in Review privilege but not the View 
Quantitation Peak Fields in Review privilege.

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The peak quantitation fields such as Area and 
Amount fields are not displayed

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However, limits set in System Suitability will be 
effective and will indicate pass/fail. Additionally any 
component-specific tailored calculations will be 
calculated and displayed.

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If the analyst does not have the View Numerical and 
Textual Results in Review privilege (regardless of 
whether the analyst has the View Quantitation Peak 
Fields in Review privilege), 

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No peak fields, peak labels, spectra or calibration 
curves will be displayed

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Analyst does not have the Allow Calibration and 
Quantitation in Review privilege 

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Allows use of the Integrate tool but not the Calibrate or 
Quantitate tools.

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The analyst will only have the ability to optimize the 
integration graphically

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System Policies and Privileges for Processing Data in Empower Software with Data Integrity in Mind

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If the analyst has the View Numerical and Textual 
Results in Review privilege and the View Quantitation 
Peak Fields in Review privilege.

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When a result is brought into Review all peak fields 
will be displayed

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When a channel or injection is brought into Review 
and ‘Integrated’ 

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Area and % Area fields can be viewed

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Amounts and other component specific fields  
are not generated

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If the analyst has the View Numerical and Textual 
Results in Review privilege and does not have the View 
Quantitation Peak Fields in Review privilege.

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Area and % Area fields cannot be viewed

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Amounts and other component specific fields are 
not generated

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If the analyst does not have the View Numerical and 
Textual Results in Review privilege (regardless of 
whether the analyst has the View Quantitation Peak 
Fields in Review privilege,) 

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No peak fields, peak labels, spectra or calibration 
curves will be displayed

Purposeful management of these two privileges can allow 
an analyst to optimize a Processing Method in the Review 
window, with a view to using that method to batch process 
results, but limit the information they can create or view  
while performing that optimization.

Allow Calibration  

and Quantitation in Review

Do Not Allow Calibration 

 and Quantitation in Review

View Numerical and Textual Fields  

in Review ✔ 

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All available peak fields can be viewed

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For Results:

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All peak fields can be viewed

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For Channels:

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Peak fields including Area and % Area 
fields can be viewed

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Component specific peak fields will  
be empty

View Quantitation Peak Fields in Review ✔

View Numerical and Textual Fields  

in Review ✔ 

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All peak fields except Area,  
Area%, Amount, and % Amount can  
be viewed

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Other component-specific peak fields  
can be viewed

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All peak fields except Area, and % Area 
can be viewed

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Component-specific peak fields  
will be empty

View Quantitation Peak Fields in Review ✖ 

View Numerical and Textual Fields  

in Review ✖ 

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Peak fields cannot be viewed

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Peak fields cannot be viewed

View Quantitation Peak Fields in Review ✖

Figure 4. Privilege Matrix controlling which peak fields can be calculated and viewed in the Review application.

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System Policies and Privileges for Processing Data in Empower Software with Data Integrity in Mind

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Figure 5. Manually saving results in Review.

Figure 6. Saving a manual result into a Result Set and batch reprocessing  

a Result Set containing manually integrated chromatograms,  

with Use Existing Integration.

SAVING RESULTS PRIVILEGE OPTIONS
Typically processing of samples to create results will be 
performed using batch processing. This ensures consistency 
and is much more efficient than processing through the 
Review window. Batch processing is required to achieve more 
sophisticated quantitation practices such as bracketing, 
summary custom fields, or using multiple processing methods 
for defined samples in the Sample Set.

The privileges associated with saving results can have  
a limiting effect on what analysts can do in Review:

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Save Results – Allows the analyst to batch process as  
well as save results while working in Review. Analysts  
not assigned this privilege cannot save results in any  
part of Empower.

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Save Results and Calibration in Review – This allows the 
analyst to save results while working in Review. Analysts 
not assigned this privilege can batch process; however, 
they cannot save any results while in the Review window.

SAVING MANUAL RESULTS IN RESULTS SETS
If data requires manual peak identification or manual 
integration, analysts may need to process and save results  
in Review. After bringing a Result Set into Review, analysts 
may perform manual integration and quantitate samples. 
Saving this result will add it to the Result Set. It is important  
to note that this does not apply when standards are  
calibrated in Review.

This privilege is required if a company perceives a need to 
Save All results created in Review and leverage the system 
policy described at the beginning of this white paper.

Figure 7. Control chart illustrating batch results exceeding warning limits  

yet passing specification.

An alternative control might be to have analysts save only 
manual integration in the Review window. This allows manual 
integration of both samples and standards. Analysts could 
then batch process with the Use Existing Integration feature 
to quantitate a Result Set that retains the manually integrated 
peaks for both samples and standards.

Knowing how these privileges impact processing of 
chromatographic data in the Review window helps  
laboratory supervisors better understand how data is 
generated by analysts. Concerns exist about an analyst’s 
ability to fine tune the integration of peaks in a sample  
to bring failing results into specification. However,  
this would only be possible for samples which are very  
close to specification without creating obviously  
‘incorrect’ integration.

For example, viewing a set of data as shown in an Empower 
control chart (Figure 7), the five results closest to the lower 
control limit may have been integrated into a passing state. 

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System Policies and Privileges for Processing Data in Empower Software with Data Integrity in Mind

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Figure 9. Background Processing and Reporting dialogue box showing  

the reason ‘why’ in the Comments box.

Figure 8. Example of tailored User Types.

Control charts are easily generated within Empower reports 
and provide laboratory supervisors a visual tool to look for 
trends in results. 

COMBINING PRIVILEGES TO MANAGE HOW USERS 
INTERACT WITH DATA IN REVIEW
Figure 8 is an example of how privileges might be assigned 
depending on job function within an organization.

Remember that a user who normally logs in as a Senior 
Analyst, may need to switch roles by logging out and  
logging in again in a Review role.

ADDITIONAL CONSIDERATIONS FOR  
DATA INTEGRITY

Locking channels from further processing
There are two further privileges associated with locking 
channels: Lock Channels and Unlock Channels.

Once results have been generated the associated channels 
can be locked so that users cannot generate any further 
results. In a Quality Control (QC) laboratory it is common for a 
channel to be locked once the result has been signed off. If a 
result is deemed inaccurate the channel can be unlocked for 
further processing by a user with the privilege to do so.

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A user can view the information associated with  
a locked channel.

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Allow Lock Channels after Sign-off 2 is a system policy 
that, when enabled, would allow a channel to be locked 
after Sign-off 2 in the Sign-off dialogue box.

Recording the reason “why?” for saving results

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Empower automatically records what actions were 
performed in the various audit trails and the user  
needs to document why they were performed. 

Figure 10. Reason why a result was reprocessed in the Result Audit Viewer.

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Users are typically expected to enter reasons why changes 
were made to project level objects such as methods, and 
system level objects such as chromatographic systems. 
It is important that these reasons reflect ‘why’ changes 
were made rather than ‘what’ changes were made.  
In regulated laboratories this is likely to be a requirement. 
In non-regulated laboratories it is not a requirement; 
however, these reasons add value by giving extra  
details about activity in Empower and could be  
seen as good practice. 

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For example, when an analyst processes a Sample Set, 
the selection of the reason why is done in the Background 
Processing and Reporting dialogue box (Figure 9).

The reason why a Sample Set was processed would then 
appear in the Project Audit Trail and the Result Audit Viewer 
(Figure 10).

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34 Maple Street 
Milford, MA 01757 U.S.A. 
T: 1 508 478 2000 
F: 1 508 872 1990 
www.waters.com

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Waters, The Science of What’s Possible, and Empower are trademarks of Waters Corporation. 
All other trademarks are the property of their respective owners.

©2018 Waters Corporation. Produced in the U.S.A.  October 2018  720006090EN  LM-PDF

There are two approaches to entering these comments – in an unrestricted manner or a 
restricted manner. Unrestricted allows the user to enter the reason why as free text. Restricted 
entry requires the user to select a predefined reason from a list. These predefined reasons are 
called Default Strings. It is important to make sure the Default Strings reflect the reason why an 
action was performed. Default Strings are created in Configuration Manager and can be created 
by any senior user with the privilege to do so.

SUMMARY
Regulators have concerns that laboratory staff could be operating with privileges that 
allow too much flexibility, or system policies which are set in an inappropriate way, allowing 
the opportunity to pass samples which do not meet specifications. It is important for both 
Regulators and Quality Units to understand software configuration and how it impacts the 
laboratory workflow as well as the data.

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It is important to understand how Empower System Policies can limit data processing.

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User types can be setup with very granular privileges to constrain how analysts create  
results in Review.

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Once results have been generated the associated channels can be locked so that users 
cannot generate any further results.

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Reviewer user types can be set up with unique privileges to suit their role which would  
allow them to view metadata and sign results, but not create or modify results.

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Empower automatically records what was done in the various audit trails and users  
should apply comments to document why it was done.