The idea is that this software creation is guided by several smaller cycles, in which functionalities are introduced, feedback is collected, and requirements reviewed, with each step being validated and formally delivered to a business (partial releases). The adoption of an iterative and incremental development process in relevant GxP applications is in the foundations of agile methodologies, such as Scrum. Adopting this appendix can help your business to perform better, while robustly maintaining compliance that is expected by regulatory agencies. Thus, to cope with these demands and achieve better results in the medium and long terms, it is necessary to seek new outlets. Although a traditional Waterfall model offers several advantages and is useful in various scenarios including a regulatory one, it has some disadvantages because it is not aligned with rapid and constant changes in the current market. The wide adoption of this method is explained by the agility and flexibility that the framework brings to business teams.

The main point of this literature is the iterative and incremental approach to the software development process and is a trend that has been dominating the market as a whole.

In 2021, ISPE® released an appendix guide entitled Enabling Innovation that was basically included in the second version of GAMP5®. This item summarizes the principles of agile methodologies and frameworks and illustrates how they can be implemented to align with GAMP5® and GxP (impact on good practices) principles.

Gamp category 4