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GxP

This module enables you to make your microscope system compliant to 21 CFR part 11. It can also be used to make your production process more reproducible and traceable.

The validation and the qualification procedures which are needed for a 21 CFR Part 11 system are not part of this module and need to be performed separately.

The module offers the following functionality:

  • Audit Trail functionality, see Audit Trail Concept
  • Signing of job templates and job results
  • Release procedure for job templates
  • Electronic signature

GxP is a general term for Good Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries. The titles of these good practice guidelines usually begin with "Good" and end in "Practice", with the specific practice descriptor (x) in between.

GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor. A "c" or "C" is sometimes added to the front of the initialism. The preceding "c" stands for "current." For example, cGMP is an acronym for "current Good Manufacturing Practices". The term GxP is frequently used to refer in a general way to a collection of quality guidelines.

Release Process of Job Templates and Job Results

In general there are the following options to activate (release) job templates and results. The release process is the same for job templates and job results.

  • One Signature Release (Default)
    This release process requires one electronic signature only. The signature is required, when you activate a job template from status Draft to Active. The electronic signature is bound to a personal certificate which will be automatically generated, if no other certificates exist on the computer. At this point you must enter your password to confirm the changing of the status.
  • Two Signature Release
    This release process allows two signatures to release a job template (4-Eye Principle). Two persons are required and therewith two signatures for releasing a job template. The first signature is required, when you publish a job template from status Draft to Published. The second signature is required, when another person activates the job template form status Published to Active. As mentioned above, the user password must be entered each time the status of a job template is changed.

Activate the desired release process under Maintenance > General Options > GxP options.

Both release processes and the template status are displayed in the flow charts below.

One Signature Release

Two Signature Release

Status of Job Templates

You must be logged in with dedicated user rights (e.g. as Supervisor) to manage the status of job templates.

The status handling of job templates will be recorded in the Audit Trail. It ensures that an operator can only work with job templates which are activated (released) by a supervisor including an electronic signature. To activate a job template and assign an electronic signature the supervisor must enter his password.

There is also another release process which requries two signatures to release a job template. This process is described in the chapter Release Process of Job Templates and Job Results.

If you have licensed the GxP module, all job templates which are created new get a particular status. After you have created a new job template (see Basics of Create Job Template Mode) the template has the status Draft. To make the template available for operators the status has to be changed to Active. If the template status was set to active, you cannot delete the template anymore. You can set the template status to Inactive, if you do not want the operators to work with the template.

Activating Job Templates with one Signature

  1. Under Maintenance > General Options > GxP the default release procedure One signature release is activated.
  2. Under Home > Manage Templates you see all available job templates and their status.
  1. Right-click on a job template with the status Draft or Inactive and click Activate.
  2. The Change Status dialog is displayed.
  3. Enter your password and click Sign.
  4. The Sign files dialog opens.
  5. From the Commitment Statement drop down list, select Created by me (authorship), and enter a Commitment Reason. Click OK to confirm your signature and activate the template.
  6. The dialog closes and the status of the job template changes to GxP status Active.
  1. In the Properties Panel, the person signing is displayed with their name.
  2. In the Verification of Signature and Files dialog, you receive the following information:
    - name of the signer
    - date and time, when the signature was executed
    - meaning associated with the signature
    - files contained.
  3. All actions and changes will be logged in the Audit Trail.
  4. The job template is now visible for all Operators in Job Mode.

Activating Job Templates with two Signatures

  1. Under Maintenance > General Options > GxP the default release procedure Two signature release is activated.
  2. Under Home > Manage Templates you see all available job templates and their status.
  1. Right-click on a job template with the status Draft and click Publish.
  2. The Change Status dialog is displayed.
  3. Enter your password and click Sign.
  4. The Sign files dialog opens.
  5. From the Commitment Statement drop down list, select Created by me (authorship), and in the Commitment Reason field, type in a reason. Click OK to confirm your signature and to publish the template.
  6. The dialog closes and the status of the job template changed to Published.
  7. A second person continues the process. In Manage Templates, this person selects the desired job template in status Published, and from the context menu chooses Activate.
  8. The Change Status dialog is displayed.
  9. The person enters the password and clicks Sign.
  10. The Sign files dialog opens.
  11. From the Commitment Statement drop down list, the person selects Created by me (authorship) and enters a Commitment Reason. The person clicks OK to confirm the signature and to activate the template.
  12. The dialog closes and the status of the job template changed to Active.
  1. In the Preview Panel, the person signing is displayed with their name.
  2. In the Verification of Signature and Files dialog, you receive the following information:
    - name of the signers
    - date and time, when the signatures were executed
    - meaning associated with the signature
    - files contained.
  3. All actions and changes will be logged in the Audit Trail.
  4. The job template is now visible for all Operators in Job Mode.

Deleting Job Templates

You can delete Job Templates only in GxP status Draft.

  1. You are in Manage Templates.
  2. You have created a Job Template in GxP status Draft.
  1. Select the desired Job Template, and from the context menu, select Delete.
  2. You have deleted the Job Template.
  3. All actions and changes will be logged in the Audit Trail.

Sign Job Results

Signing job results is part of the two signature release process.

As a reviewer, you can activate or reject job results within the release process. The name of the signers, the date with time and the meaning associated with the signatures are displayed in the audit trail.

Activating Job Results

  1. You are in Browse Results.
  2. The job result is in GxP status Published.
  1. Select the desired result and from the context menu, select Sign Job.
  2. The Change Status dialog is displayed.
  3. Enter your password and click Sign.
  4. The Sign Files dialog is displayed.
  5. To activate the job result, from the Commitment Statement drop down list, select Approved by me. In the Commitment Reason field, type in a reason.
  6. In the Preview of Signature section, the commitment reason is displayed.
  7. Click OK.
  8. You have changed the GxP status to Active.
  9. In the Preview Panel, both of the signers are displayed with their name.
  10. In the Verification of Signature and Files dialog, you receive the following information:
    - name of the signers
    - date and time, when the signature was executed
    - meaning associated with the signature.
  11. All actions and changes will be logged in the Audit Trail.

Rejecting Job Results

  1. The Two Signature Release Process is activated.
  2. A job is run and the result is saved in the Archive and is in GxP status Published.
  3. As the second signer you are in Browse Results.
  1. Select the result you want to reject. From the context menu, select Sign Job.
  2. The Change Status dialog opens.
  3. Enter your password and click Sign.
  4. The Sign Files dialog opens.
  5. From the Commitment Statement drop down list, select Rejected by me, and in the Commitment Reason field, type in a reason.
  6. In the Preview of Signature section, the commitment reason is displayed in red color.
  7. Click OK.
  8. You have rejected the result.
  9. The result is in GxP status Inactive.
  10. In the Preview Panel, both of the signers are displayed with their name. Your name as the rejecting signer is marked red.
  11. In the Verification of Signature and Files dialog, you receive the following information:
    - name of the signers
    - date and time, when the signature was executed
    - meaning associated with the signature.
  12. All actions and changes will be logged in the Audit Trail.

Audit Trail Concept

By licensing the GxP module the Audit Trail functionality becomes available in the software. It is accessed via the Maintenance tab.

The Audit Trail functionality allows to record and/or log all software specific actions performed by the user. Note that the functionality applies for the Job Mode. In Free Mode the functionality is not effective.

In the Audit Trail window you see the log entries in a list as soon as the module is active. You can export these log files in .PDF or .html format. It is also possible to show the results of a particular date. Therefore, under Time Range you adjust the desired dates in a calendar. A search by keywords is implemented as well.

Actions to be Recorded in the Audit Trail

All audit relevant actions performed with the software are recorded and logged.

Note that changes in the Ligth Path tool are not tracked in the Audit Trail. For tracking hardware changes the Light Path Editing tool must be used.

The following list shows the most important actions which are logged:

Actions to be logged

Text/Log (exemplary)

Activating GxP (Category: ModuleActivation)

"The GxP module has been activated."

Deactivating GxP (Category: ModuleDeactivation)

"The GxP module has been deactivated."

Opening a certain mode (Category: EnterMode)

"Maintenance - Toolkit Manager"

Leaving a certain mode (Category: ExitMode)

"Maintenance"

Starting up and shutting down the software (Category: Startup/Shutdown)

"Starting ZEN core Version 3.11.105.00000"

Deleting a job template in status draft. (Category: Delete)

"The following item was deleted: 'Job Template in status draft'

Logging in/off (Category: Logon/Logoff)

"User 'Z' has logged on."

Entering and exiting different modes (Category Enter/Exit Mode):

"User 'Admin' has entered Maintenance Mode."

Executing job templates (Category: Execute)

"Execute template 'XYZ' with Status 'Active'."

Changing of parameters (Category: Execute)

In task 2 "image Processing" the following parameters have changed: Brightness from "0" to "50".

Changing status of job templates (Category: Set/Status)

"Status of template 'XYZ' changed from 'Active' to 'Inactive'."

Adding a comment in the Save Results dialog. (Category: Set/Status)

"Comment: Save Results Dialog 'Date' - 'Time'
'Text of the comment'.

Changing the Archive location

"The archive location was changed to: ..."

Changing the Local Storage location

"The local storage location was changed to: ..."

Changing of Templates in the Archive (Category: Manage Templates)

"Job template 'Template 2' was created."

User Management

"User 'XY' was created."

Messages and Errors (Category: Warning/Error))

"Scaling is invalid."

Using the Electronic Signature (Category: SetStatus)

"Status of template 'XYZ' changed form 'Draft' to 'Active' (Electronic Signature)."

Checking Audit Trail

All actions made by the user or the system are seamlessly recorded in the Audit Trail tool. You find information about, e.g. when users logged in, what actions were performed and when they logged out. You can check the audit trail for changes any time.

  1. You have run a job template and saved the results.
  2. You are in Browse Results.
  1. Select the desired job result, and from the context menu, select Show Audit Trail.
    As a supervisor, you additionally have the option to choose Maintenance > Audit Trail.
  2. The Audit Trail dialog is displayed.
  3. You receive the information if the Audit Trail is completely valid.
  4. In the Time Range area, you can use the calendar to set the time period that you want to check. Note that this is only visible for Supervisors.
  5. The time record is filtered according to your selected time range.
  6. In the table the following information is displayed:
    -Time
    -User
    -Category
    -Description
    -Comment
  7. To reset the time range, click
  8. The complete audit trail is displayed.
  9. In the Search field, type in a word, and to search downwards, click

    to search upwards, click
  10. The record with the word you were searching for is selected. Use the icons to proceed.

Exporting Audit Trail

You can export the audit trail in .PDF or .html format. The .PDF document is write protected so that it cannot be changed in Adobe Acrobat.

  1. The Audit Trail dialog is displayed.
  1. Click Export.
  2. The Save Audit Trails dialog opens.
  3. Select whether you want to export a .PDF or .html format, and enter a file name. If necessary, navigate to the directory in which you want to save the file. Click Save.
  1. The file is exported to the desired directory.
  2. The .PDF document is write protected.

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