GxP Module in ZEISS ZEN core

Your Solution to Implement Traceable Microscopy Workflows

Make Microscopy Secure and Compliant with Regulation Requirements

The GxP module in ZEN core imaging software enables traceable workflows through seamlessly integrated microscopy hardware and software, and meets the requirements of regulated industries.

The module helps:

Quality Managers who want to guarantee reproducible results and secured processes
Validation Engineers who want to be able to validate their microscopy processes
Lab Managers who need to document their microscopy processes
IT Managers who are interested in backup/disaster recovery functionality, and archive/database capability
Pharmaceutical companies who need to be compliant to e.g. FDA 21 CFR Part 11

Highlights

Audit Trail

User interactions recorded in the Audit Trail

In the Audit Trail, all interactions will be recorded (according to a risk based approach). Reproducibility and traceability of all end-result relevant actions are done. The Audit Trial is check sum protected and therefore prohibited from changes. Beside others, following activities are recorded in the Audit Trial:

Start up, shut down
Login, logoff of users
Change of parameters while running a workflow
Creation of results in the archive
Changes in the result archive
Error messages
Changes in user management

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User Management /
User Roles

User management combined with Job Mode functionality

Precondition for a GxP environment is a user and user role management. You can configure the user privileges of the software as a supervisor. This makes sure that only users with the respective skills can use certain functionalities. You can also set up workflows for repetitive tasks with Job Mode. Microscope parameters can be predetermined to guarantee reproducible results. Combine Job Mode with user management functions to assign inspection tasks to certain users and user groups.

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Release Procedure of Workflows

Verification of electronic signatures

Workflows will be released by using a defined release procedure. Using a checksum and electronic signature process ensures no changes in released – production ready – workflows.

Checksum Protection of Data
Workflows, job templates, and result data are electronically signed and checksum protected from later modification.