The creation of qualification documents is often a resource-intensive task that is difficult to calculate for suppliers of machines and/or software who serve customers in the GxP-regulated environment.
Customers have numerous requirements and the level of detail of the information varies very often. Nevertheless, suppliers want to deliver adequately in line with demands.
To remedy this, gempex has developed a kind of "modular system".
In the presentation "Development of an Agile Documentation Structure", which Dr. Georg Schwarz, Principal Consultant at gempex, will give in German language at LOUNGES 2025, this new solution - here primarily for automated systems and software - will be presented.
The technical lecture will take place on Wednesday, 26. March 2025, 5 p.m., lecture room 3, in the dm-Arena in Karlsruhe.
The keytopics are:
- Principles of supplier documentation according to GMP
- Dealing with different requirement specifications
- Documentation kit, basic package, add-on modules
- Technical implementation options
The aim of the presentation is to show a way in which the creation of required documents can be simplified, standardized and yet tailored to specific needs.
Anyone wishing to attend the lecture can register to visit the Lounges and use the code "Lounges-KA-2025-gempex" for free admission.
If you have any questions about IT validation, software validation and GxP compliance documents for suppliers, Dr. Georg Schwarz is available via contact@gempex.com.
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