Development of an Agile Documentation Structure
gempex GmbH · Dr. Georg Schwarz
26/03/2025, 17:00 · Room 3 · DE
Suppliers, e.g. of machines or software, who supply customers in the regulated environment of the life sciences industry often face the problem that the requirements are specified at very different levels of detail. In addition, the implementation of the projects is often handled very differently by the customer. When processing these projects, it is often unclear which documentation has to be delivered in which level of detail. Furthermore, the different customer requirements for documentation represent an effort that is difficult to calculate. The aim of the presentation is to show a way to simplify and standardize the creation of the required documents.Agenda
- Efficient creation of GxP-compliant supplier documents
- Principles of supplier documentation in accordance with GMP
- Dealing with different requirement specifications
- Documentation kit, basic package, add-on modules
- Technische Umsetzungsmöglichkeiten