Agile in GxP CSV Environments: The Use Case

- Ecaterina Altemüller


This article tells the story of a team I had the pleasure to lead on a GxP project in a Healthcare company. The team members were of different age, professional background and culture. Most of them had the project work on top of their regular daily work. They showed extraordinary dedication and genuine curiosity for the new agile approach I introduced to them. 

The task at hand was to replace an electronic Document Management System (eDMS) with a more user friendly and intuitive solution. First, we wanted to make sure that the selected solution satisfies these criteria not only on paper but also in practice. Therefore, we built a Proof of Concept (PoC) environment and invited all our Subject Matter Experts (SMEs or key users – used interchangeably) to test it. After getting the thumbs up from the SMEs and the Steering Committee, the full-scale implementation followed. 

While there is a lot to share, I would like to focus on three points in this article. The first section – “To Scrum or not to Scrum?” – shows my perspective, as a project manager, when selecting the optimal approach for this project. The other two sections present the measures I took to facilitate the team to the Scrum way of thinking. More in detail, the second section – “A story about the user story” – illustrates my experience with introducing user stories to the team. The third section – “Sneak preview” – highlights some of the challenges we faced when giving the SMEs early DEV access to the new system. 

To Scrum or not to Scrum? 

Scrum (or agile – used interchangeably, which does not limit agile only to Scrum), eDMS and Computerized System Validation (CSV) could be regarded, especially by those of you knowledgeable of these topics, as three puzzle pieces that don’t really fit together. While it is true that eDMS implementations are rather straight forward and CSV requires documentation before action (quite the opposite from agile), I believe that Scrum can add value even in such traditional settings. Let me define each of these three puzzle pieces one at a time. 

Let’s start with eDMS. The reality is that the eDMS market is a mature one. That means there are enough vendors claiming to offer best in class eDMS solutions waiting to be configured according to your industry and company needs by switching on or off readily built features. The development per se, where functionality is being built from scratch, is kept to a minimum. Therefore, eDMS implementations are straight forward, “no thrills” software configuration rather than software development projects. 

Let’s continue with GxP and CSV. In heavily regulated industries, such as Healthcare, GxP is a collection of quality standards to assure safety and efficacy of products for the patient through delivering high quality of e.g. laboratory, manufacturing or other processes. IT systems used to support such processes must undergo CSV. That means, the System Development Life Cycle or Change Control has fixed stage gates with specific documentation (as specified by the company validation framework) and milestones aligned in a waterfall sequence (DEV to VAL to PROD). 

And the third and final puzzle piece, Scrum. Without going into details, Scrum is an iterative approach or an agile framework for teamwork that defines the team structure, artefacts and events. According to Shenhar and Dvir (Reinventing Project Management” by Aaron Shenhar and Dov Dvir), iterative approaches are best suited to deliver good results in situations of great uncertainty. Therefore, it is not a coincidence that Scrum first picked up for software development projects. The more certainty on a project, the more suitable the classical project management approach becomes. 

This brings us to the point. Great uncertainty is definitely not a characteristic of the eDMS implementation projects. And how to go about the waterfall-aligned documentation and milestone requirements as per CSV? In other words, how agile can you be on a “no thrills” software configuration project that imposes documentation and milestones that seem to misalign with Scrum? As I show in my article Agile in GxP CSV Environments - The Concept, Scrum can benefit even regulated projects by providing the means to end this-is-how-it-was-always-done cycles: a fresh way of thinking and working. 

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Please also read my first article of this series: Agile in GxP CSV Environments: The Concept

Agile in GxP CSV Environments: The Concept

Are you skeptical or convinced about the compatibility of agile IT system implementation and Computer System Validation (CSV)? You didn’t make up your mind yet? Or are you just hungry for information? In any case, if you are looking for an opinion about when and how to apply an agile approach (or Scrum – used interchangeably) on regulated projects, keep reading. To make the most out of this article however, you should have basic project management, agile and GxP or CSV knowledge. 

In this article, I show how to apply Scrum on projects where the technical solution must undergo CSV (see the “How to Scrum?” section). As such, I touch on how Scrum artefacts do match to the validation documentation. Before talking about how to apply Scrum however, I start by sharing my thoughts on when to apply Scrum (see the “When to Scrum?” section). This agile framework is so much more than a way of working. It is also a way of thinking. Understanding this is key to agile implementations. 

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Go on a roller coaster ride with me!

- Do-Hee An & Marijan Divkovic

What's really odd about roller coaster rides is the fact that it brings up good and bad feelings to our bodies and minds. Experiencing the acceleration and loosing control of our own senses is a lot of fun and can make us feel terrified at the same time. And even if we know that we might leave the roller coaster feeling queasy, we still do not want to miss out on this type of experience.

A very special roller coaster ride that I definitely wouldn't have liked  to miss, was the recent bpExperts innovation event which I attended together with some of my colleagues, a group of young professionals called icons - consulting by students and customers of bpExperts.

The goal of the event was to answer the following breakthrough question:
"How can social media help to represent bpExperts and its values in an authentic manner and promote the work at bpExperts as attractive and fulfilling."

To find answers to this question, we followed an ideation method called "Riding the creative roller coaster" by Nowhere. To let our creativity flow, this special type of roller coaster ride was conducted in the middle of Bavaria´s nowhere where no disturbances of big city traffic can be found, and life is rather simple. The method, location and the whole setting around the event already made me feel very curious. However, looking at the agenda and getting to know that the curves and loops of our roller coaster ride will be determined by three main stages - Onboarding, Unknown, and Illumination - made everything sound very mysterious.

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At the beginning, I quickly found out that the purpose of the onboarding was to familiarize the group with each other. We did a short personal introduction during which each person characterized oneself in three words. Those key words helped us to identify our individual strengths and to define our group´s secret sauce. The introduction triggered a vivid discussion about personal values and helped to create a strong bond between the participants right from the beginning. The discussion was a very interesting experience for myself as I have never thought a lot about my personal values. Therefore, this point triggered me to think about things that are important to me in my life.

Shortly after the opening round we dived into the deep unknown.  In small groups we discussed different topics under the theme 7 generation mapping. The discussion challenged us to view things from different perspectives and decades. My group focused on the topic: what makes an employer attractive - in the past, present and future.  The exercise gave us all the opportunity to answer a question based on what we know and experienced in the past and present and also to create a vision about future developments of the same.

The 7 generation mapping and the secret sauce were only two of the activities that we engaged in our first day. Another very remarkable activity was the evocative talk that was introduced to us during dinner. For this task we were supposed to prepare a short speech for the next morning related to anything we found interesting during the first day.  The speech itself was supposed to be short and the goal was to move the audience emotionally rather than to convince the listeners with arguments. The evocative talks, as I could see in the next morning, were a very emotional and moving experience for all participants. One speech that still stuck to my mind was a story of one participant explaining that he cannot work with people who completely disagree with his values and even break them. This triggered again an inner discussion in my head about my own values and what is important for me. The participant´s words helped me to understand my own disappointments at certain situations and people. I understood that I feel hurt and even betrayed when someone I trusted before hurts the values that I believe in.  

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The highlight of the event was reached when we did the iteration in pairs. After doing a long inspiring walk - the intuition walk - in the surrounding area, each of us started to draw something that should answer the breakthrough question. After creating and discussing the picture we were grouped in pairs and created a new one. We continued this task until we finally had one group picture where the ideas of everyone were involved. The final picture does not only show our common idea of how to present our company values in a social media campaign, but it is also a collection of all our individual and common values and visions of how to live and express those.

This exercise finally helped us to overcome the border between the known and the unknown and finally to reach illumination. The innovation event was definitely the most interesting roller coaster ride I have ever experienced. The combination of the method we used, the broad diversity of participants as well as the location that was in the middle of nowhere were very significant factors that nurtured creativity and helped us to come up with innovative ideas. As a follow up of the innovation event, we kicked off the bpExperts social media campaign which will be presented to you very soon!

Are you interested in experiencing a similiar roller coaster ride? bpExperts also supports other companies in organizing and conducting such events.

Webinar: Agil mit ARIS am 26.01.2017

Der Einsatz von BPM mit einer prozessorientierten Vorgehensweise ist heute – insbesondere in der Design-Phase – de facto der Standard im Umfeld von Business Transformationen. Gleichzeitig werden agile Methoden wie zum Beispiel Scrum zunehmend bei der Implementierung von Projekten eingesetzt. Wie funktionieren beide Ansätze zusammen im Projekt und wie können diese sowohl methodisch als auch mit einem Tool optimal begleitet werden?

Anhand eines konkreten Anwendungsfalls stellen wir Ihnen ein agiles, mehrjähriges SAP-Implementierungsprojekt vor und zeigen Ihnen, wie unsere Reise durch das Projekt mit dem Einsatz der Scrum Methodologie erfolgreich durchgeführt werden konnte. Außerdem zeigen wir Ihnen, wie ARIS als One-Tool Lösung zu Durchführung eines agilen BPM Projekts genutzt wurde. 

Sie sehen den agilen Aufbau eines SAP Templates von Anfang bis Ende. Zu Beginn erfahren Sie, wie die Backlog Items anhand der BPM Business Requirements hergeleitet und ein priorisiertes Product Backlog Modell überführt wurden. Im Weiteren erhalten Sie Einblick in:

  • Backlog Items und ihre Attribute (Beschreibung, Definition of Done, geschätzter Aufwand, Wertgenerierung)

  • Scrum Board Modell und dessen Einsatz, um die Backlog Items in konkrete Aufgaben zu übersetzen

  • Der Einsatz von Burndown Charts in einem Mash Zone Dashboard, um den Fortschritt der Teams in den einzelnen Sprints darzustellen

  • Inkrementelles Testen, um sicherzustellen, dass die Ergebnisse der Definition of Done entsprechen

  • Test der Systemintegration



Successful with process-driven SAP implementation

- Russell Gomersall

bpExperts and Software AG held a joint Webinar on the topic on how process management helps secure the success of SAP projects.

Although most companies have realized how important their business processes are for aligning business requirements within IT initiatives there is still a lot of room for improvement on how to exploit the potential across the whole process respective project life cycle.

Picking up this topic Joséphe Blondaut from SAG started the session by presenting the ARIS capabilities in the context of SAP projects. Based on this my part was to a present a specific customer use case of a mid-sized company which changed towards a process centric SAP implementation approach using ARIS across the whole process life-cycle. Having a good insight on how the projects were executed before and after the shift, it is a good study on where the major and measurable benefits lay. One main finding is that especially the repetitive character of roll-out tasks within typical SAP template projects (such as site verification, fit/gap, localization and defining roles and authorizations) allow a higher return of the upfront investments into BPM. You can see the recording of the webinar on our Youtube channel. We are looking forward to meeting you there for more videos on our webinars and trainings.