The GxP module enables traceable workflows through integrated microscopy hardware and software, and meets the requirements of regulated industries. If GxP is installed, Technical Cleanliness Analysis (TCA) supports it.

Any time you change a setting of a configured workflow, this is logged in an audit trail.

GxP logs if you do the following:

  • If you change the standards to be applied.
  • If you change data in the Particle Segmentation workbench, e.g. the threshold.
  • If you change data in the Size Distribution workbench or in the Edit View. If you change particle types, edit, cut, merge or delete particles or parts of it.

The result of conducted particle revisions is stored to the archive and to the audit trail. The resulting Particle Revision Table is visible in the Browse Results mode and generated independently of an installed GxP module.

Example

  1. GxP module is licensed.
  2. Under Maintenance > Options > GxP > GxP Options, you have activated Require comment on workflow changes.
  3. You have loaded a job template to run it.
  1. In the Standard Selection workbench, change the default standard by deactivating one of the standards.
  2. The Comment parameter changes dialog is displayed.
  3. Type in a comment and click OK.
  4. The parameter change is saved to the audit trail. If you do not add a comment, you cannot proceed or step back.
  1. Under Maintenance > Audit Trail, you can display the logged changes.
  2. The list of conducted particle revisions is stored additionally to the archive.
  3. You can export the data to your local PC in PDF format.