adesso Blog

Fitting an agile development project into a waterfall-driven CSV framework and quality system can be a challenge. The first part of this series describes thorough preparation of some key topics before the start of the project to set a good foundation for this endeavor. Like the agile ceremonies and artifacts, the CSV tasks should be an integral part of the overall agile project planning. Likewise, the agile development approach is recommended to be described in the Validation Plan. This article shares best practices and observations and gives insights to some concrete activities that should be considered during the course of such a project.

When introducing SAFe, companies, their Agile Release Trains (ART) and teams inevitably also deal with the definition of Program Increment Objectives (PI Objectives for short) and the assignment of planned and realised Business Value. This is a valuable means of communication between the Business Owner and teams. When used correctly, the process of assigning Business Value to each defined PI Objective makes an important contribution to building software that puts customer added value at the centre of development.

Self-organisation is a guiding principle of the agile working model. But what does self-organisation mean for leadership work in real terms? And how is it possible to ensure that the strategy is still pursued? In this post, I’ll be providing further information on the self-organisation of agile teams and their leadership from the perspective of management and executive-level staff. Along with that, I will also outline the approach a company needs to take when developing the organisational framework if it wants to become more agile.

Agile approaches are now very widely accepted. Scrum is often used as a framework and fixed events (meetings) are specified, among other things. Projects in the insurance industry often employ an agile approach, too. Despite that, employees and stakeholders sometimes harbour prejudices. I used to be project controller in a previous life, during which time I was involved in an agile project and was confronted with prejudices at the beginning. In my blog post, I would like to talk about prejudices and my own practical experiences regarding agile approaches based on Scrum.

Scrum and other agile frameworks have been gaining a lot of traction lately, especially in IT projects. These project frameworks are mainly characterised by greater flexibility, faster responsiveness and a stronger focus on end users. Today, Scrum is often combined with other proven methods, techniques and frameworks – such as Kanban, Design Thinking and BusDevOps. What all these approaches have in common is that the chosen path is reflected on in an iterative process and that adaptation to the desired state often requires creativity on the part of those involved. This blog post explores the question of how successful ideas can be generated while also adhering to the objective of maximising the product.

Computer System Validation (CSV) in GxP-regulated industries like pharmaceutical and medical device manufacturing is the testing and documenting to see if the software is fit for its intended use, is compliant to external regulations and internal procedures, thus providing a high degree of assurance that risks to patients, product quality and data integrity are minimized. This first part of the blog describes how to plan and what to do prior commencement of the project to fit in the agile validation approach with an existing CSV V-model process.

Diversity plays a crucial role in meeting complex and ever-changing challenges. In my blog post, I use a simplified model to explain what this means and how agile practices help a diverse team solve complex problems.