Lecture
Advancing GxP-ready Microscopy: From Qualification to Data Integrity
- at -
- A3.527
- Type: Lecture
Lecture description
Advancing GxP-ready Microscopy: From Qualification to Data Integrity The presentation is aimed at users and interested parties from the biotech and pharmaceutical sectors and is also interesting for participants from the medical technology industry. You will get an overview of ZEISS as a company and its global orientation and portfolio. In particular, you will learn how ZEISS can support you with its microscopes in a regulated environment. You will learn about the meaning and central aspects of the term GxP. A brief outline of the ZEISS microscope portfolio with various light and electron microscopes leads you to the ZEISS microscopy software ZEN core, including its workflow and database functionalities. A GxP-compliant workflow within ZEN core is shown and the audit trail and backup functionality is described. Finally, it will be presented how ZEISS microscopes are qualified, and the software is validated in accordance with GxP standards, and what certificates ZEISS provides you with. This is proven by reference projects, the number of which has risen steadily over the last few years. In summary, it is explained how ZEISS can support you in the qualification and validation of your new or existing microscope system.
