Industry 3.5: Bridging the Gap to Industry 4.0

Table of Contents

The Path to Industry 4.0

Key Concepts and Terminology

Competitive advantages of Industry 4.0

Challenges to Industry 4.0

What can we do today?

The 4.0 Future

Frequently Asked Questions (FAQ)

Technological advancements are being achieved at breakneck speeds. Not only in the traditional definition of increasing compute speed, like Moore’s Law says, but in the vast capabilities of software platforms continually being developed. One of the biggest recent achievements in technology is the general access of Artificial Intelligence and Machine Learning being readily available to corporations and individuals. 

There is a lot of buzz about how to enable these technologies to add their values to the business and one of the biggest hurdles to make use of the technology is to have a standard data model that aligns data across the organization. Industry 4.0 is here to bring those standardizations to organizations, which are currently indebted to the Industry 3.0 software currently deployed. This article will explain how the current software installed onsite could be configured to work together today, to start working towards a standard data model and implementation of Industry 4.0 concepts.

The Path to Industry 4.0

The third Industrial revolution began in the 1970s, fueled by computing and programable controllers becoming more generally available and attainable. Slowly but surely companies started adopting the new technology Industry 3.0 offered to gain the competitive advantage against their competitors. 

At the same time, the life sciences industry was in a period of growth and discovery. Governments around the world were beginning to understand that the industry needed guidance and oversight to ensure the safety of patients and proper testing necessary to release a new medication. The FDA releases 21 CFR Part 210 and 211; Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs, and Finished Pharmaceuticals. As the adoption of computers and controllers gained traction in pharma, it was found that there still needed to be guidance to provide additional identifying information such as audit trails, record of actions, and traceability. To provide the proper guidance, the FDA released 21 CFR Part 11 to define how an organization should handle electronic records and electronic signatures. 

All the above factors and more have heavily influenced the decisions made by companies in the technology they invest in and in the policies and procedures they have created and maintained. One could say that organizations have become accustomed to setting things up using Industry 3.0 ideology having followed it for the past 50+ years. Now a new industrial revolution is beginning, Industry 4.0, and its goals are to get the computers we already have working for us via Industry 3.0 to talk to each other and work collaboratively via Industry 4.0. 

Industry 4.0 is a fundamental mindset shift in architecting an organization. The organization becomes interconnected and digitized leading to increased access to data, enhanced compliance, and many more benefits. Companies want to gain the benefits touted using Industry 4.0 but can’t change course overnight. There is a growing need of guidance for companies to make measured changes to move towards the fourth industrial revolution, while maintaining the same technology, policies, and procedures currently in place. 

Key Concepts and Terminology

Industry 3.0

Industry 3.0, also known as the Third Industrial Revolution, refers to the period of technological advancement that led to the automation and computerization of various industrial processes. It marks a significant shift from traditional manufacturing methods to more automated and efficient production systems. The key characteristics of Industry 3.0 include the widespread use of computer-controlled systems, the introduction of programmable logic controllers (PLCs), and the initial integration of digital technologies into manufacturing processes.

Industry 4.0 

Industry 4.0 is a common industry term used to describe the fourth industrial revolution that is currently happening in manufacturing. The fourth industrial revolution builds on the third by enhancing existing computerized systems with data and analytics. Industry 4.0 is characterized by leveraging cloud computing, machine learning (AI), and connected devices through the Internet of Things (IoT). 

Unified Namespace (UNS)

A Unified Namespace (UNS) is a software solution that facilitates the usage of Industry 4.0 tools. The UNS acts as a centralized hierarchical repository of master data models used throughout the enterprise. The models include data, information, and context where any application or device can publish or consume data needed for its use.

Digital Transformation

Digital Transformation is the process to take an Industry 3.0 organization into Industry 4.0. It’s a holistic shift of all digital processes that aims to align technology initiatives with business objectives, customer needs, and market trends. It leverages modern technology to reshape various aspects of an organization to enable data backed decision making. 

Competitive advantages of Industry 4.0

As described in our white paper, Why Life Science Manufacturing Needs Industry 4.0, Industry 4.0 is comprised of 9 key pillars:

  1. Robots – Robots can automate repetitive tasks without human interaction to increase productivity. This allows operators to focus on more complex tasks and decision-making.

2. 3D Printing – 3D printing allows for product personalization. In the manufacturing space, it might be used to print replacement parts locally, reducing potential downtime waiting for a part to ship from a tier 1 supplier.

    3. Augmented Reality – Augmented reality provides easily accessible visual data. One application could be to utilize virtual reality headsets for training operators to handle hazardous scenarios without any of the associated risk.
      4. Internet of Things (IoT) – IOT is the implementation of sensors or probes that connect to each other and the internet to provide new data. With IOT, almost anything can become a smart device by placing a sensor on it.
        5. Big Data – Big Data prevents data from “disappearing” as it moves up the stack. Instead, it enables all data produced by the business to be contextualized and analyzed.
          6. Digital Twin – A Digital Twin is a software model of the manufacturing plant. This twin may be used with Artificial Intelligence or Machine Learning to predict problems or compare against floor data to identify optimizations.
            7. Cloud Computing – Cloud computing enables the use of third parties to store data in the cloud to reduce costs and make factories easier to scale.
              8. Cybersecurity – With interconnectivity and networking, factories can ensure compliance by protecting data across interconnected systems.

                9. Systems Integration – Interconnected systems allow seamless data transfer. Data no longer need to be siloed into individual stacks

                The above tools are all focused on utilizing data-driven technologies to overcome the technical limitations identified from Industry 3.0. So, simply if there is a desire to adopt Industry 4.0 concepts start incorporating the tools described.

                  Challenges to Industry 4.0

                  Industry 4.0 concepts have been exhaustively tested in other industries, but not heavily yet in the pharmaceutical and biotechnology worlds. The early adopters are starting to see the benefits of the technology, but even getting to a starting point had some challenges. In our project experiences so far, we have seen issues arise with changing the status quo, validation, and software integration.

                  Bucking the status quo is most definitely the biggest hurdle of any new software implementation. Since Industry 4.0 is a fundamental shift in mindset those that do not understand the concepts tend to just oppose. There are various reasons people are hesitant, ranging from concerns about compliance, risk, lack of education on Industry 4.0, or even cultural reasons. 

                  Compliance is of the utmost concern to life sciences. Without the approval from the FDA a company can’t sell their products. To ensure that the new solutions being implemented in Industry 4.0 is compliant validation and quality groups will also need to support the cause of Industry 4.0 but won’t see the benefits from the beginning. 

                  Another complication is the current web of software that has been weaved through the fabric of the enterprise. Maybe disparate systems semi vertically integrated together to cobble together the data necessary to provide for the compliance part. There has been much time spent to get to the current state and it can’t just be thrown out without proper consideration. The other piece is that Industry 4.0 is a mindset and not software, so we can’t just upgrade.

                  What can we do today?

                  Industry 4.0 is still in its infancy, especially within the life sciences industry. It will take time to for its concepts to keep gaining traction and being implemented, whether starting from a greenfield or brownfield state. If a company is starting today without the correct mindset, it will instantly be behind its more advanced competitors. If the company has been doing things the way it has for years then it’s time to reconsider and reoptimize the process. Some of the concepts to transition from Industry 3.0 to Industry 4.0 are covered in our white paper Challenges of Implementing a Unified Namespace in the Life Sciences.

                  The biggest and best thing that anyone can do today is to just start doing small things to prove out the results for yourself:

                  • Try proofs of concept: See how the technology responds. You’ll start seeing the easy wins we all talk about so much in Industry 4.0. Once the framework is in place it will start to get easier and easier to complete projects and provide more value to the organization. 
                  • Start working on Education: There is plenty of material available on Industry 4.0 today. Go learn from some of the best leaders out there, such as IntegrateLive!. Get personal trained on it today so they understand how to do things in a more efficient way.
                  • Find the right partners: Find the correct people to help you through the process of digital transformation. Make sure they are willing to be agnostic when suggesting software and are proposing dynamic and agile solutions. 

                  The 4.0 Future

                  Industry 4.0 technologies signal a shift away from the established 3.0 workflows and technologies we all grew accustomed to over the past 20+ years. This shift from familiar to the unknown can be daunting for many to fully understand and has many associated risks. However, the sooner an organization starts to incorporate 4.0 technologies into their business operations the better positioned they will be as time goes on. Industry 4.0 technologies allow for better integrations across the business, and companies that refuse to incorporate them will find themselves farther and farther behind the competition. 

                  Skellig encourages exploration in this topic and are happy to talk about any concepts you’d like to run by us. Skellig would love to become your partner to collaborate and create this new Industry 4.0 world together. 


                  1. If my organization is standardized on Industry 3.0 does that mean we have to start from scratch?

                  a. No, there are several methods to slowly move your systems from Industry 3.0 to 4.0, check out Challenges of Implementing a Unified Namespace in the Life Sciences for some ideas.

                  2. Are there any successful case studies or examples of organizations in the life sciences sector that have successfully adopted Industry 4.0 principles?

                  a. Yes, read our case study on Unified Namespace Implementation in a Pharmaceutical CDMO.

                  3. How do existing software systems and processes from Industry 3.0 need to be adapted or integrated to align with Industry 4.0 principles?

                  a. Industry 3.0 focuses on vertical integrations where each integration was a discrete connection, while Industry 4.0 focuses on centralizing integrations to have easily scalable connections.