Overview of Industry 4.0 or Digital Transformation: Are you ready?

Industry 4.0 refers to the fourth Industrial Revolution through the use of cyber-physical systems. It consists of using the digital technologies to make manufacturing more agile, flexible and responsive to customers.

Industry 4.0 digitizes and integrates processes vertically across the entire organization, from product development and purchasing, through manufacturing, logistics and service. All data about operations processes, process efficiency and quality management, as well as operations planning are available real-time, supported by augmented reality and optimized in an integrated network[1].


Features of Industry 4.0 are horizontal, vertical and digital integration of the entire system [2]. Key areas are:

  • The standardization: Companies will easily connect to each other
  • The management of complex systems: it is necessary to develop and apply new models and methods
  • A comprehensive infrastructure (high-quality information network, Internet connection), security and privacy in data protection
  • The work organization and design: the roles of the employees are changed, they are more involved, progress is better and there is life-long learning
  • A legal framework: harmonization of legal frameworks
  • The effective use of resources in terms of potential savings of raw materials and energy.

It is important that managers from companies understand the industry 4.0 and how it looks in reality.

A- Origin of Industry 4.0 concept

Industry 4.0 is a strategic initiative of the German government that traditionally heavily supports development of the industrial sector. In this sense, Industry 4.0 can be seen also as an action towards sustaining Germany’s position as one of the most influential countries in machinery and automotive manufacturing.

The basic concept was first presented at the Hannover fair in the year 2011. Since its introduction, Industry 4.0 is in Germany a common discussion topic in research, academic and industry communities at many different occasions [3].

B- What is Pharma 4.0?

Pharma 4.0 consists of a digitalization of Pharmaceutical Industry. Pharma 4.0 will connect everything, create new levels of transparency and speed for a digitalized plant floor. This will enable faster decision-making and provide in-line and in-time control over business, operations, and quality. It will also require higher levels of security, since connected systems heighten vulnerability [4].

C- What is Quality 4.0?

Quality 4.0 is the application of the Industry 4.0 technologies to quality. It is not really a story about technology. It’s about how that technology improves culture, collaboration, competency, and leadership. Quality 4.0 includes the digitalization of quality management. More importantly it is the impact of that digitalization on quality technology, processes and people [5].

So, it’s about the digital transformation of quality management systems and compliance.

During the past decades, Quality is applied in 3 distinct ways:

  • Inspection
  • Design
  • Empowerment

In Quality 4.0, quality depends on:

  • Discover and aggregate Data Sources
  • Discover Roots Causes
  • Discover Insights About Products, Services and Organization

Important note: Quality 4.0 doesn’t replace traditional quality methods, but rather builds and improves upon them. Manufacturers should put in place a framework and interpret their current state and identify what changes are needed to move to the future state.

D- Where to start?

Obviously, this will depend on the Operational Maturity Level and how advanced you are in terms of process automatization and the implementation of Artificial Intelligence features into the Manufacturing process as well as all vertical and horizontal supply chain. Data, Metadata and big data management, their maturity level and control strategy are also a prerequisite for successful implementation of digital enterprise applications.

For all common companies, the following processes and steps should be implemented and successfully completed:

1- Review your Corporate Strategy and Vision

Redefine your Corporate Strategy by implementing new business models. Indeed, Companies should need to understand the impact of digital transformation throughout their business [6].

2- Processes and data Standardization

One of the most important challenges in the implementation of Industry 4.0 is processes and data standardization.

First, streamline your activities to improve operations efficiency, productivity, product quality, inventory management, and asset utilization, time to market, agility, workplace safety and environmental sustainability.

Then, adopt a reference architecture that provides a technical description of standards and enables effective communication between all users and processes, integrating the production, systems and stakeholders of management. This allows to ensure the interoperability of systems and to reach their full potential [7].

3- Digital Transformation (Digitalization)

a- Vertically across the entire organization, from product development and purchasing, through manufacturing, logistics and service.

b- Horizontally beyond the internal operations from suppliers to customers and key value chain partners.

Create intelligent processes, procedures, products, services, business models and customer access. That means you will digitize and integrate processes [1]:

4- Cyber Physical System

Create a link between the virtual world and the physical objects within the real world by using an appropriate Internet of people (IoP), Internet of Things (IoT), Internet of Service (IoS) and Internet of Data (IoD) Tools. This because Internet of Things (IoT) connects machines, objects and people in real time and Cloud Computing offers storage solutions as well as exchange and management of information allowing production and business processes to be combined in order to create value for the organizations [7].

5- Employee Empowerment

Empower your employees by involving them from the outset in selecting the technology you want to implement. You have to share your vision for why this choice is important to the company, how it will enhance the value you deliver to your customers and how it will affect employees’ jobs [8]. The task of a management is to make workers understand the inevitability of change, because it facilitates the work of the employees, and they can be involved in work which is more creative and has higher added value [9].

We all know that Employee qualification is an important topic across all industry sector. The digital change will alter requirements for employees across all steps of the value chain, from development though production to sales [1].

6- Cybersecurity by Design

Adopt the Cybersecurity by design. Here the key words are Security and Digital Protection. That means the cybersecurity measures should be built into the digital transformation processes. Industry 4.0 companies should secure their IoT devices and assure they are integrated into existing automation and information system architectures. The challenge is to understand the potential cyber risk that innovation bringsby performing Cybersecurity risks assessment and mitigation action plan, and cybersecurity qualification (CyQ). The cybersecurity by design requires to creating a robust and secure network infrastructure and upgrade or replace legacy systems[5].

In addition to the above-mentioned processes, Pharma Companies have to complete the following steps by taking into account Quality by Design principles:

7- Process Analytical Technology (PAT)

Integrate PAT principles and tools to design and develop well understood processes that will consistently ensure a predefined quality at the end of the manufacturing process. Such procedures would be consistent with the basic tenet of quality by design and could reduce risks to quality and regulatory concerns while improving efficiency[10]. PAT tools can be categorized according to the following:

  • Multivariate tools for design, data acquisition and analysis
  • Process analyzers
  • Process control tools
  • Continuous improvement and knowledge management tools

8- Data Integrity by Design (DIbD)

Implementing Data Integrity by Design. Data Integrity by Design (DIbD) is a systematic approach to data lifecycle management that begins with pre-defined objectives and policies and emphasizes data quality and criticality, based on sound science and quality risk management.

In this proactive approach and process, data integrity should be built into the process design and product development.

9- Quality by Design (QbD)

Getting in-depth understanding of the process and its control strategy. A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Because no one can test/measure quality, we have to build quality into the product.

Proper implementation of QbD will provide three (3) main benefits for development [11]:

  • More efficient use of development time and costs;
  • Ability to meet Regulatory submission guidelines and expectations;
  • Reduced approval times and fewer queries from the Regulatory Agencies.

10- Validation by Design (Validation 4.0)

In this approach, the validation activities should no more follow the industry standard V‑Model as described in the Good Automated Manufacturing Practice, GAMP5. Instead, the validation execution should follow the principles of Quality and Data Integrity by Design. The Validation activities should take place through the process design and product development that establish a correlation between the Definition of Requirements, Validation Process and Data Lifecycle with a solid Risk Based Approach.

Validation by design will transform the way the validation is traditionally performed where the system requirements are verified during the Performance Qualification and/or User Acceptance testing. Applying Validation by Design will require to adopt a new way of thinking and working as the system requirements should be verified during it development, configuration and implementation.

Should you need more information and/or a support, Contact Mivado GlobalPerformance or our Forum Pages.

11- References

  1. PWC, 2016 Global Industry 4.0 Survey, Industry 4.0: Building the digital enterprise, www.pwc.com/industry40 (accessed: Feb 14, 2019)
  2. M. Crnjac; I. Veža; N. Banduka, ‘’From Concept to the Introduction of Industry 4.0’’ International Journal of Industrial Engineering and Management (IJIEM), Vol. 8 No 1, 2017, pp. 21-30
  3. Andreja Rojko (2017), Industry 4.0 Concept: Background and Overview, iJIM ‒ Vol. 11, No. 5, 2017
  4. ISPE.org, Pharma 4.0, https://ispe.org/initiatives/pharma-4.0 (accessed: Feb 15, 2019)
  5. Dan Jacob, Quality 4.0 and Strategy Handbook, LNS Research, https://www.lnsresearch.com/ (accessed: Feb 15, 2019)
  6. Senior Experts at CGI (2009), Industry 4.0, Making your business more competitive, www.cgi.com/manufacturing
  7. B. Paiva Santos, F. Charrua-Santos and T.M. Lima (2018), Industry 4.0: An Overview; https://www.researchgate.net/publication/326352993 (accessed: Feb 1, 2019)
  8. The Business Development Bank of Canada (BDC), Study (May 2017), Industry 4.0: The new Industrial Revolution – Are Canadian manufacturers ready? https://www.bdc.ca/en/about/sme_research/pages/industry-4-new-industrial-revolution.aspx (accessed: Feb 15, 2019)
  9. Judit Nagy, Judit Oláh, Edina Erdei, Domicián Máté and József Popp (2018), The Role and Impact of Industry 4.0 and the Internet of Things on the Business Strategy of the Value Chain—The Case of Hungary; Sustainability 2018, 10, 3491; doi:10.3390/su10103491; www.mdpi.com/journal/sustainability (accessed: Feb 14, 2019)
  10. FDA, Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm088828.htm (Accessed on 2019-03-31)
  11. White Paper, What Is Quality By Design (QbD) – And Why Should You Care?; https://www.outsourcedpharma.com/doc/what-is-quality-by-design-qbd-and-why-should-you-care-0001 (Accessed on 2019-05-26)

About the author: Kossi Molley, Chemist, LSSBB