Vorstellung GAMP 5
Einleitung – Überblick
Beratung Computervalidierung, Reutlingen
Korrespondenz: Friederike Gottschalk, Beratung Computervalidierung, Jägerweg 15, 72766 Reutlingen (Germany), e-mail: Friederike.Gottschalk@csv-consulting.de
GAMP 5/Introduction – Overview
Former versions of GAMP 5 preferred the V-model as the – more or less – only paradigm for the development of computerized systems. GAMP 5 changed this approach, now current trends in software engineering are viewed as equal to the Vmodel by the authors. No model is anymore preferred. Since GAMP 5 it is important that the development follows the life cycle of a computerized system as well as the Quality by Design approach, which means that quality must be engineered into the system (source code) because documentation gives not the only evidence.
Predecessor versions of GAMP 5 already tried to define scalability but that goal was not completely reached. Now, with the toolbox of GAMP 5, scalability is easier to implement. Determining factors for scalability in GAMP 5 are 1) category of a system, 2) impact to patient safety, 3) complexity and novelty of a system, 4) result of supplier evaluation and 5) risk assessment.
Nowadays most of the systems used in regulated industry are pre-configured and pre-tested by their suppliers. Therefore, instead of a widespread testing, a more focused testing of functions that can affect patient safety should be outlined. But – of course – a supplier who is working along a predefined Quality Management system is a precondition for a reduced and focused testing to be sufficient.
Dealing with other topics like CSV in embedded systems, use of open source products and handling of data when doing data migration from a legacy system to a new system makes GAMP 5 an industry guideline where the subtitle “CSV in an economic way” meets its contents.
Key words Lieferantendokumentation • Ökonomische Validierung • Quality by Design • V-Modell