GxP Lifeline

3 Characteristics of Successful Quality 4.0 Initiatives

3 principles of Quality 4.0

Industry 4.0 – the fourth industrial revolution that features the emergence of advanced digitisation and the increased connectivity of intelligent technologies – is having a profound impact on life sciences industries. Smarter, more connected technologies are revolutionising the way pharmaceutical products and medical devices are developed, manufactured, and used. As the evolution of Industry 4.0 continues to unfold, quality management is playing an increasingly vital role for companies across the industry. Modern technologies and capabilities are blending with traditional methods of managing quality, which has culminated in a novel Quality 4.0 approach that fundamentally changes what quality management systems are and do.

Today’s quality leaders are faced with the challenge of knowing the best way to invest in and apply advanced Quality 4.0 tools such as:

  • Artificial intelligence (AI).
  • Blockchain.
  • Cloud computing.
  • Connected and edge devices.
  • Data lakes and “big data.”
  • Machine learning (ML), a subset of AI.

The execution of a Quality 4.0 initiative takes thoughtful planning, a systematic strategy, and a thorough understanding of the Quality 4.0 elements that will be the most favourable for your organisation. If you’re looking to get started, first familiarise the decision-makers in your company with these three characteristics that are shared by Quality 4.0 initiatives that successfully transformed and streamlined quality management in other life sciences companies.

  1. Target the Areas That Will Benefit Most From Quality 4.0 Tools
  2. The first step in any Quality 4.0 initiative should be focused on planning. You can begin by identifying potential use cases for advanced analytics, apps, or other technologies that enhance connectivity. Compare specific functions where improvement is most needed with the various Quality 4.0 tools available. This will allow your organisation to set realistic expectations and make it easier for decision-makers to chart a roadmap for future successes.

  3. Focus on Aspects of Quality 4.0 That Most Closely Match Your Needs
  4. LNS Research, a trusted industrial transformation advisory group, has identified the 11 essential components or “axes” of Quality 4.0.1 The manner in which each axis is leveraged and synchronised with the other elements of Quality 4.0 varies widely according to a company’s unique business needs and circumstances. Each of the integral aspects listed below plays a critical role in any Quality 4.0 initiative and should be evaluated against and incorporated into use cases based on your company’s current standing and desired future state.

    1. Data:
    2. Bad metrics are the biggest barriers preventing companies from reaching their quality objectives. Life sciences companies are much more likely to yield the real-time quality intelligence and predictive insights they need to thrive in today’s fast-paced and highly competitive markets if they base their Quality 4.0 initiative on a data-driven quality model.

    3. Analytics:
    4. You can’t make good, timely decisions without up-to-date, accurate, and readily reportable quality information. Modern analytics tools like MasterControl Insights propel Quality 4.0 initiatives by providing up-to-the-minute data updates, interactive dashboards, and robust data exploration and sharing capabilities.

    5. Connectivity:
    6. Quality 4.0 initiatives are useful for bridging the gaps between operational and information technologies. Companies may now seamlessly link enterprise systems and ensure that data stays synchronised between them by taking advantage of the advanced integration capabilities that Quality 4.0 tools offer.

    7. Collaboration:
    8. Process automation has taken quality management far beyond what was possible when everyone in the industry was reliant on paper-based, manual processes. Now, Quality 4.0 tools are advancing efficiency even further. Blockchain and other innovative technologies make it easier to detect defects, boost data security, and effectively combine quality and supply chain data.

    9. Quality Management Systems:
    10. LNS Research reports show that only 21% of companies have implemented a quality management system (QMS) software solution. Of those companies, 41% implemented standalone QMS solutions, contradicting the primary tenets of Quality 4.0: enhanced connectivity and the integration of disparate system. You can ensure data connectivity across the life cycle of your products by implementing a quality management system solution that fully integrates quality processes. The end result of enhanced, Quality 4.0-enabled integration is fewer errors and delays.

    11. Compliance:
    12. The availability of new Quality 4.0 tools creates more opportunities to digitise and optimise compliance activities. An evaluation of the systems and strategies you currently use to maintain compliance can help you identify functions that could benefit most from modern Quality 4.0 tools and approaches.

    13. Scalability:
    14. Most life sciences companies’ quality improvement efforts are impeded by the inability of their existing systems to scale data, users, devices, and analytics. It’s a worthwhile endeavor to investigate the various ways data lakes, cloud solutions, and other Quality 4.0 tools could enhance scalability.

    15. Leadership:
    16. Every Quality 4.0 initiative will fall flat without executive buy-in. Quality leaders can build a business case with the C-suite by clearly defining the links between quality objectives and corporate strategic objectives.

    17. Competency:
    18. The baseline competency of personnel and the transfer of specialised knowledge between individuals can be dramatically improved by using Quality 4.0 tools. New purpose-built technologies are designed to optimise quality-related competency activities like employee training and training record management.

    19. App Development:
    20. Augmented reality (AR), virtual reality (VR), and wearable devices have the potential to become powerful Quality 4.0 tools. While many of these interactive devices may not seem to have a place in quality management, assessing their impact may help you discover new ways to enhance your quality activities.

    21. Culture:
    22. A Harvard Business Review survey showed that a culture of quality is lacking in 60% of employees’ work environments.2 Quality 4.0 is aimed at eliminating that problem by improving connectivity. Adopting modern tools that make it easy for all employees to share information, collaborate, and take ownership of quality will help companies develop a stronger quality culture.

  5. Align Your Digital Transformation Objectives With Quality 4.0 Principles
  6. The purpose of a Quality 4.0 initiative is to enhance connectivity and extend a culture of quality across the enterprise. Therefore, it must be in harmony with the organisation’s digital transformation strategy. Many organisations’ digital transformation efforts are in their infant stages or are insufficient to meet the demands of a full-fledged Quality 4.0 initiative. In these circumstances, a Quality 4.0 approach presents a valuable opportunity to realign organisational and quality digitisation strategies to better evaluate how new technologies can synergise and elevate them.


Quality 4.0 is much more than a broad Industry 4.0 ideology to be applied to a quality management system. Fundamentally, it is a mechanism for preparing for the future by equipping your company with advanced, connected, and purpose-built tools. The new breed of innovative Quality 4.0 tools will help your organisation conduct quality processes more efficiently and with greater visibility and ultimately enable you to attain your business objectives sooner.



James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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