Expert Statement: Markus Zeitz, Novartis

The Transition to Digitalization in the Pharmaceutical Industry

06.09.2021 - ISPE and its members are developing the roadmap to introduce Industry 4.0, also called the Smart Factory, at the pharmaceutical industry as Pharma 4.0 – an operating model that is interconnected, meaning that the digital tools allow for a fully connected network to enable direct communication between all levels in an organization.

Despite the transformational potential of digitalization, the pharma industry has historically been slower than other sectors in adopting digital tools, such as cloud storage, artificial intelligence (AI), machine learning (ML), blockchain, and remote communication technologies, and in ­mak­ing associated changes in workplace culture and strategic priorities. Now, however, the Covid-19 pandemic may be accel­erating the pace of change.
What are the digitalization trends in the industry? What is the business case to develop and implement digital tools and digitalization strategies? And how can organizations introduce and use them?

CHEManager asked executives and industry experts to share their views on digitalization trends in the pharmaceutical industry and challenges on the way to realize the sector’s digital transformation. We proposed to discuss the following aspects:

  • What do you think are the key digitalization trends in the pharmaceutical industry?
  • What do you consider to be the most important benefits of digitalization in the pharmaceutical industry?
  • Is your company involved in system­atic, ongoing action to digitalize operations?
  • At present, digitalization in the pharmaceutical industry is immature. In your view, what are the biggest obstacles that need to be overcome in the digitalization of the sector?
  • How would you rate the digital maturity level of your company?



“Built on the renewed IT landscape
an enterprise-wide data lake supported by
a solid master data governance will be a key enabler
for digital transformation projects.”


Markus Zeitz: For quality, the digital journey will continue to focus on the standardization of key quality systems (e.g. exception handling, change control, document management, batch release, lab systems). These systems will embrace the benefits of cloud computing wherever possible. Built on the renewed IT landscape an enterprise-wide data lake supported by a solid master data governance will be a key enabler for digital transformation projects. The access to high quality data will be the foundation for transformational projects using state of the art digital tools like machine learning, artificial intelligence, internet of things and block chain. Some of these tools will require investment in new standardized platform applications on the enterprise level. Novartis Quality is embracing operational excellence and playing in all the above-mentioned fields focusing on standardized key quality systems, insight generation based on high quality data and automation of transactions. At Novartis Quality, we are leveraging data and digital to improve compliance and to increase efficiency at the same time. To be truly transformational and unleash the power of our people we embrace the Novartis values of being a workplace, which inspires curiosity in our employees and allows them to work in an unbossed way.