Crossing organisational boundaries

By Ralph Haefeli of Novartis

Novartis implemented a global manufacturing execution system solution in support of a paperless and highly integrated manufacturing concept in 2000. Since then, we have rolled it out to many of our pharmaceutical manufacturing sites worldwide.

Our main expectations when moving from paper-based manufacturing to paperless manufacturing with built-in online controls were to implement a completely new way of working and to have a proactive control of compliance. With the built-in controls at every step in execution, all the necessary preconditions are checked immediately. This allows us to prevent errors. In that respect, we haven’t really improved compliance, but we have reduced the risk of being not compliant by reducing the possibilities to make errors. And we really have seen the error rate drop.

In addition, we have reduced the amount of administrative work by going paperless. We have freed up capacity in the organisation to absorb more volume without necessarily increasing the work force.

Last but not least, because we now capture all the information electronically, we have a much higher transparency about our processes. With these insights, we are in a very good position to continuously improve our processes.

Challenges
We have, of course, come across some implementation challenges, especially for the first project. It is very important to understand that this is not an IT project, or not mainly an IT project. It’s fundamentally a new way of working, and as such has to be managed as a business re-engineering project rather than a technical implementation of a system.

This determines which people you need to have in the team, which is essentially all departments in the manufacturing locations, be it engineering, quality, planning, warehousing, logistics, production, packaging or quality. It is an environment which, over years, has learnt to work with paper and was now asked to trust the system by scanning a bar code. That’s quite a mental change. It was a challenge to make the whole organisation understand the change and commit to it; but without that, they would never really make effective use of the system.

Another challenge was the integration of the new technology, and its validation. We weren’t sure at that time what the FDA and EMEA would make of a completely electronic batch documentation. Moving on, however, it has been a benefit approaching it globally. All the subsequent projects went much smoother.

Improvements
Ourcurrent business strategy is about taking the next level of operational excellence for the whole manufacturing and supply network of Novartis’ technical operations. The principles we apply are the well-known principles from other industries, such as Lean manufacturing and Six Sigma. We are also moving away from a planning based to a more demand driven supply chain.

In essence, this means that we need to improve agility, flexibility and speed, while at the same time becoming more cost effective. We need to make sure that whatever we do in IT is fundamentally supporting these business needs, and align our priorities with the business priorities. You can only do that if you have a deep understanding on where the business wants to go and what the challenges are.

The way we build solutions, and the way we deliver solutions, also has to be cost effective over time, because these systems stay in operation for quite a while. So our strategy is to go for simplification, for integration and for reusability, rather than introduce new technologies with every new project.

These two key elements are supporting the business strategy by being as responsive and supportive as the business needs to be, as well as making contribution to cost. Information management is changing. It’s about providing transparency in a more global business context, which is also more process-oriented. End-to-end process visibility across organizational boundaries is key. It’s not easy to provide information manually and, at the same time, quickly and accurately. IT can be a real enabler for the business by providing this transparency.

Ralph Haefeli is Head of Global TechOps IT within the Global Technical Operations Function at Novartis Pharma AG, located in Basel, Switzerland. His role includes defining the IT strategy in support of the overall Global TechOps strategy and ensuring implementation as well as integrity and compliance of all IT operations and systems.