Christian Schmitz-Moormann, Life Sciences Facilitator, Generis

Remember the scene in ‘Back to the Future’ where, having travelled back in time to 1955, Marty McFly plays a song at a school dance, and introduces Rock’n’roll to the audience for the very first time. While new and unexpected, the dancers quickly picked up the concept and enjoyed the new sound. Marty knew what the audience needed, before they even knew they wanted it.

Like Marty in that scene, we have a message we want you to think about:

It’s time for a paradigm shift.

At Generis, we think that the traditional evolution of processes and systems across all quality-related domains has reached a point where improving the ratio of effort to gain is coming to a standstill.

What’s the problem?


The workload continues to increase, transparency and traceability of all tasks and decisions is a mandatory requirement, and your stakeholders and peers would like to have your results faster and more easily digestible for them.


For core processes (for example ICSR management, signal detection) process maps and systems have been developed over multiple decades and have reached a high level of maturity. That is a big plus.

On the other hand, these processes and their related systems have become highly complex, and it requires a great deal of effort to maintain them. More often than not, changes affect the process chain end to end, requiring thorough impact and risk assessments, which in turn drive your testing and verification approach. The results of these modifications are often only incremental, but many changes are required to stay compliant with evolving regulations and to remain compatible with developing technology.

The pain has been reduced somewhat by moving the systems to the cloud. But that creates other dependencies and limitations.

If we look to other processes, which are important nonetheless (SDEAs come to mind, or generation of the PSMF), we still see a predominant usage of ad-hoc tools like Word and Excel, and storage in shared drives like SharePoint for example.


At the system level we encounter additional challenges: initially, systems were built as monoliths, each with their own individual data store. Leaving the resulting siloes behind has been, and in some areas still is, a challenge. Duplication of processes and of data causes the need for expensive reconciliation. To allow processes to be used across business domains, interfaces had to be built for specific purposes, adding to the overall complexity of the systems. For analysis purposes, specific data warehouses need to be built to remove the load from the production systems.

So, the question is, can this situation be improved?

At Generis we say, “Yes, it can”, and our customers agree.

What’s the solution?

Our solution is a move away from long end-to-end processes to a network of process chains, which are driven by the data used and generated in the context of their specific use.

At the core of this is our Structured Information Lake, which allows us to ensure that any type of data (including documents) can be entered just once, and reused limitlessly.

Context can have many aspects, including time, date, and location, but most important to the users are intended use, access, and role. In a nutshell, it is about bringing up everything you need in a specific situation to perform what you are asked to do. But the approach also includes conceptual changes; we encourage you to use value chains in addition to the legacy verticals to determine your use cases, and that includes going across boundaries, which is made seamless in our CARA Platform.

The CARA Life Sciences Platform provides the tools to create and manage your specific process elements using no/low-code approaches. And will support you in avoiding the information lake becoming a ‘data swamp’.

Currently many organisations have a disjointed IT landscape. Siloes are connected in multiple, but limited, ways and have been taken to the cloud, external systems are connected through specific interfaces and even a data lake is connected. Still, the connections are limited, fragmented, and all-in-all create a very complex and expensive IT landscape.

The visualisation above represents the structure of the CARA Life Sciences Platform; all processes sit atop the single, structured information lake, allowing for holistically connected data, content, and processes available across all departments.

This structure, and the mentioned conceptual alignment are the basis we propose to use for building a Quality Value Network.

How do we get there?

Here are some basic how-to’s for weaving the Quality Value Network:

Remove the boundaries

Being open is a prerequisite:

· Think and work across key domains

· Open communication is key

· Documents and data no longer need to be separate entities

Leverage existing knowledge

You already have many functioning processes and information entities available, which you use and know well. So, use those. Also, taking a different perspective can give you additional insights.

Develop a cross-functional transformation team

It is helpful to establish a cross-functional team which aids you with delivering to the Quality Value Network across boundaries. Being part of such a team is a great opportunity for growth, both business and personal.

Start small and evolve consistently

Weaving the Quality Value Network is a sustained process and can be a great learning experience. Start small, with high value individual processes, those which are causing a real pain point, or deliver additional value by broadening the context. As you learn, move to more complex situations which involve multiple processes and information entities.

Don’t let the individual project become too large.

Generis is dedicated to helping you move forward with modern, innovative solutions. For more than 20 years Generis has been supporting its customers to identify and adopt relevant new concepts, enabling organisations large and small to generate high value while delivering on the required compliance.

If you’re interested in learning more about how the CARA Life Sciences Platform can connect your end-to-end processes, or to request a demo, get in touch today at