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

Key Notes update - Business Transformation Day 2019

Gülsüm Ucuran

On September 26th, our Business Transformation Day will take place at our customer Merck KGaA in Darmstadt. With a panel of key note speakers and participants from diverse organizations we will discuss how BPM delivers tangible benefits. The topics will span from global ERP template programs to enterprise quality management and operational excellence.

Please look forward to: 

  • Managing multiple ERP templates and projects within a single integrated BPM platform.
    Carsten Schöne, Business Process Owner Govern to Enable, Merck KGaA

  • Process orientation in pharmaceutical research and development - a BPM approach to quality management.
    Marc Seyfarth, Head of R&D Business Process & QD Management, Merck Healthcare KGaA

  • Supporting corporate consolidation while assuring quality system maturity.
    Gregor Kokorski, Head of Project Management, Mitteldeutsche Hartstein-Industrie AG

  • The fate of system process documentation after go-live. Template governance and as-is process documentation in a multi-site set-up.
    Katharina Koston, Project Manager, Phoenix Contact GmbH & Co. KG

Additional group discussions and breakouts provide the space for stripping away the jargon and jointly create new insights.

The participation is free of charge. 

  • 26.09.2019, 9:00 - 16:00 Uhr

  • Darmstadt

Please understand that the number of participant space is limited. More information about the travel accommodation and the event flyer will be sent to the registered participants shortly.  

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. 

Read further here

Business Flows Release 4 Available Now

- Rachael Föcker

Business Flows Release 4

Since our last release in July 2018, we have reflected on our project experience and customer feedback and spent the last several months improving Business Flows once again. From our experience in Business Transformation and process design initiatives, it is clear is that an End to End (E2E) perspective fosters operational excellence. The principle is to iteratively define a standard set of processes and (re)use these in various combinations to reflect all operational varieties in the business flows.


For the sake of ‘house-keeping’ this set of (unique) processes requires a structured view on the process inventory. This is typically accomplished in a repository by sorting the processes into process groups according to functional criteria.

We, frankly speaking, didn’t publish the process groups until now, as we didn’t want to distract from the core E2E focus of Business Flows.

Using Business Flows in various customer situations has shown that a reference model for the functional grouping of processes as well as a structured repository (defining the business process master list, BPML) is of great benefit.

We are, therefore, happy to announce that we have updated our published architecture and conventions in order to bring you another perspective to Release 4 of our Best Practice Reference Model: Process Groups.   

Process Groups

The introduced process groups are structured according to the SCOR top-level entry structure. Leaning on this widely used framework simplifies initial orientation for process experts with various backgrounds without limiting us to functional silo thinking.

Our Process Groups cluster individual processes in a functional representation similar to operational departments. For example, within the Customer Relationship Management functional group you will find a collection of processes for strategically shaping the relationships and interactions of an organization with existing and potential customers, including planning and execution of campaigns, gathering and qualification of leads, and the generation and distribution of marketing materials. Our classified functional building blocks offer a streamlined approach to gather the relevant business experts to review, adapt, and agree the reference model according to their business operations. In this sense, the combination of the Process Library and E2E view accelerate adapting operational processes to support company strategy. 

We adopted established SCOR framework terminology across the supply chain: source, make, store, sell, and service and extend it by design, plan, service, integrated management system, enterprise management, and quality & compliance management. 

Figure 1: Process Library

Figure 1: Process Library

In addition to providing a functional view on processes, the process groups also allow us to accommodate for stand alone processes that do not typically map to an E2E process such as generation of reports, modification of sales order or purchase orders, or maintenance of Master Data processes that needs to be included in a comprehensive BPML.

With the introduction of the process groups, we have taken the initiative to replace the generic departments on the level 2 processes with the respective process group allocation indicating functional responsibility.  This decision was made to incorporate feedback on frictions when customers were mapping the reference content to their individual organizations and corresponding role definition and naming.

Figure 2: E2E Scenario - Inbound Logistics

Figure 2: E2E Scenario - Inbound Logistics

As I write this the team has started working working on the next release of Business Flows where we will provide you with new E2E domains including Forecast to Plan (F2Pl) and Hire to Retire (H2R) with their respective process groups covering Human Resources, Sales and Operations Planning and others.

We are curious to receive your feedback and why not discuss the new concept and content live at our customer event in September - so save the date and come to exchange on how business transformation is a capability, not a project!

In case you want to have a closer look at our reference content, feel free to get yourself a free trail.