Suppliers of machines or software that supply customers in the GxP-regulated environment regularly have to fulfill customer requirements that vary greatly in their level of detail. When fulfilling these requirements, it is often unclear which documentation must be supplied and to what level of detail. Furthermore, these customer requirements for documentation are an effort that is difficult to calculate.
To remedy this, gempex has developed a standardized yet agile documentation structure as part of its IT Validation range of services.
The aim is to deliver GMP-compliant documents that meet the specifications and customer requirements with as little effort as possible.
How does this work?
Basic requirements that concern the documentation of software are identical, for example, with regard to the data integrity of the computer systems.
The corresponding system configurations must be described in design specifications for customers in a GMP-regulated environment.
The content composition of these specifications and the associated test documents can be uniformly structured and standardized. It is precisely this structure that gempex develops together with the supplier. Similar to a "modular kit", a "basic package" and a collection of "specials" (standard documents) are finally available.
This documentation structure is subsequently permanently implemented at the supplier and is available in every new project as a quickly accessible stock template. Only the customer-specific parameters then need to be added in the respective projects. Optimized effort for maximum benefit!
gempex can also provide on request support in verifying quality in the product development process (software or machines). Quality-relevant steps are focused on and a path to documentation is shown.
The procedure is described in an InfoSheet "IT-Validierung: Qualifizierungsdokumente-Baukasten" (German language only) from gempex.
For any questions on this topic, Dr. Georg Schwarz, Principal Consultant at gempex GmbH, will be available via contact@gempex.com.
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