The GxP module in ZEN 2 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
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
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.
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.
In case of a hardware breakdown, IT managers benefit from backup and restore functionality to make sure the systems are back up and running quickly.