ZEISS Microscopy Knowledge Base
Help
ZEISS Microscopy Knowledge Base
Search

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

Clipboard icon with plus connected by arrows to three rounded rectangles, center rectangle highlighted blue

Two Signature Release

Flowchart: 'Create New Job Template' clipboard → 'Status Draft' → 'Status Published' → 'Status Active' and 'Status Inactive'.

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.

ON THIS PAGE

PRODUCTS
ZENX Ray SoftwareEM SoftwareSolutions Lab
ABOUT ZEISS
AboutCareerNewsroomCompliance
Social Media
LinkedInFacebookYouTubeXInstagram
Impressum
Carl-Zeiss-Strasse 22
73447 Oberkochen
Germany
Legal