Build a pragmatic digital transformation roadmap in a gxp environment

There is a clear buzz around new technologies to develop a Pharma 4.0 landscape in the life sciences industry. This makes its implementation challenging. To reduce stress when selecting these technologies and be realistic with the status-quo of each plant, it is key to build a pragmatic digital transformation roadmap.

Like all complex challenges, it should have as simple a solution as possible. It starts with a three-step approach:

Step 1: Carry out an audit to find out the status of the plant in terms of digital transformation capabilities: people, technology and processes.

Step 2: Agree on a roadmap in which all stakeholders of the organization (vertical and horizontal) participate to define the desired digital maturity in the short and medium term.

Step 3: Execute the agreed roadmap efficiently, supporting new initiatives after successful small-scale use cases, on time and with technologies and vendors with proven expertise.

There are many different digital maturity models to define the state of a plant and give an overview of the requirements needed to progress to the next levels and become a truly digital site.

One of the most pragmatic and realistic is the digital maturity model of the center developed by Biophorum. Since its creation in 2004, BioPhorum has become an open environment in which the main leaders of the biopharmaceutical industry openly share and discuss new trends and challenges they face.

BioPhorum currently has more than 135 manufacturers and suppliers deploying their top 6,000 leaders and subject matter experts to work in nine “focused Phorums”.

BioPhorum ® ha desarrollado un Digital Plant Maturity Model (“Modelo de madurez de la planta digital”) para abordar todo lo anterior con un enfoque muy pragmático. They have defined the technology and business requirements needed to advance the different levels of digital maturity, regardless of the current digital level of the plant.

The 5 levels of digital maturity defined by BioPhorum ® are well described in their paper “Digital Plant Maturity Model – DPMM”. In summary:

  • Level 1 (Pre-Digital Plant)
  • Level 2 (Digital Silos)
  • Level 3 (Connected Plant)
  • Level 4 (Predictive Plant)
  • Nivel 5 (Planta Autodirigida)Level 4 (Predictive Plant)

To assess the level of maturity of a plant, two categories have been established:

  • Business Capability Dimensions: This category includes the main business capabilities needed to design, build, operate and maintain the digital plant and its role in the end-to-end business value chain.
  • Enabling Capability Dimensions: Includes the capabilities of people, processes, technology, and information required to enable the above business capabilities.

In particular, when approaching “Level 4: Predictive Plant” or even earlier, a roadmap for AI (Artificial Intelligence) implementation must be defined. In this regard, “Xavier University” has established its own methodology based on working groups that include professionals from the FDA, academia, and biopharmaceutical companies.

The “AI Maturity Model poster provides a good overview of how to assess an audit and develop an AI-related roadmap:


1) Performing a digital maturity level audit is a must to start your digital transformation journey. There are several options. Let’s start with an easy and pragmatic one such as the “Digital Plant Maturity Model” defined by BioPhorum ®.

2) To develop and execute a digital transformation roadmap, one must be realistic with internal capabilities (people) and budget constraints. A good approach would be: start with small parts of the overall roadmap supported by use cases, then the scaling factor will justify the rest of the deployment.

3) Choosing the right partner to carry out the audit and help you define and execute the roadmap is key. Also, the more agnostic and independent the engineering vendor, the better for defining and executing the conflict-free roadmap for deploying certain software packages.

At Klinea we have proven experience in the design and implementation of digital solutions for biopharmaceutical companies. Our engineering approach allows us to recommend only the best solutions to our clients, without any external interest. If you want to know more about digital transformation in GxP environments and how we can help you, contact us: