The new version of GAMP® 5 was issued in order to update several areas of content included in the previous 14-year-old version, as there was a need to implement the technical and methodological changes that have taken place in recent years.
In particular, this guideline implements the concept of Critical Thinking, which has also been dealt with in other guidelines. Critical Thinking is outlined in a new appendix explaining its application through the system development life cycle and all supporting processes.