Quality Management

Validation 4.0 and Quality 4.0 in the Life Sciences Industry

Quality Management

November 17, 2021

Share this...
Share on facebook Share on twitter Share on linkedin Youtube

Industry 4.0 and Quality 4.0

A new industrial revolution has resulted from technological advancements during the last decade. The fourth industrial revolution, often known as “Industry 4.0,” is a term used to describe this period. The exponential proliferation of disruptive technologies, as well as the changes that these technologies are bringing to the Life Sciences industry and the markets that they serve, are driving the revolution.

Quality 4.0 is a concept used to describe the status of quality and organizational excellence in the future. This is part of the Industry 4.0 framework. This is leading organizations to enhance their quality best practices as well as adopt new digital disruptive technologies required for this new Quality of the Future. To support aspects of Quality 4.0, traditional validation practices are also undergoing a major shift – leading to the term Validation 4.0 .

The Role of Validation 4.0

For Industry 4.0 to succeed in the Life Sciences industry, there needs to be a new mindset relative to validation across the value chain. It needs to incorporate new technologies that enhance product quality and the safety and efficacy of drugs and medical devices for the patient. There needs to be a transition to a data-powered technology driven approach to compliance.

The objective of Validation 4.0 is to provide a risk-based method for process performance qualification that involves a uniform, coordinated and unified approach to computer system validation . It is based on the Pharma 4.0™ operating model and includes a thorough control plan, as well as digital maturity and data integrity by design. This approach will aid in the support and facilitation of existing and future pharmaceutical industry improvements.

Key Focus Areas to Consider with Validation 4.0

In order to evolve the organization and enhance the process towards Quality 4.0 and Pharma 4.0, organizations need to consider how to approach Validation 4.0. It requires an in-depth understanding of the products and processes, data, integration, and documentation.

Understand Products and Process

Quality by Design

The more the organization understands regarding the key aspects of their products and processes, the better they can concentrate their efforts towards finding and implementing appropriate controls to improve quality. The approach should focus on incorporating design aspects and controls into the value chain at various phases and continuously rather than a holistic check towards the end of the process, thus attempting to mitigate risks throughout the process.

Ensure Data Integrity

Data Integrity by Design

Data is centric to the organization. It needs to be visible to those that need to access it and leverage it across the organization. Validation is impacted by bad data and specifically when data is not integrated across functions of the organization. Integrated data is critical to Validation 4.0.

Integrated System Across Value Chain

Integrated Environments

Current technologies like IoT have provided a means to capture and make visible key information across the entire value chain. This information is key to ensuring Validation 4.0.

Digital Documentation centralized and processes

Modern Documentation

A critical area to consider regarding validation is documentation. Going away from a paper-based approach to a digital approach where all the data is centralized versus in multiple places is imperative


Validation 4.0 is a key component to Quality 4.0 and Pharma 4.0™. In order for it to be successful the organization needs to transition to a data-powered technology driven approach to compliance. It requires an in-depth understanding of the products and processes, data, integration, and documentation. Understanding the organization’s products and processes is critical in order to better concentrate efforts towards finding and implementing appropriate controls to improve quality. Additionally, the organization’s data needs to be integrated across the organizational functions and visible to those who need to utilize it. Additionally, documentation needs to go digital and be centralized by the organization.

Why it Matters to You

In order for Life Sciences organizations to improve the safety and quality of their products, there needs to be an incorporation of Validation 4.0. It is the cornerstone needed in order to optimize the organization’s quality function.

In this blog, we discuss several important areas to consider when looking to evolve the organization towards Quality 4.0 and Pharma 4.0 leveraging Validation 4.0, they are:

  • Understanding the key components that facilitate Validation 4.0
  • How understanding products and processes play a role
  • How data, integration, help to ensure success
  • Documentation’s role in getting to Validation 4.0

About Astrix

For over 25 years, Astrix has been a market-leader in dedicated digital transformation &  staffing services for science-based businesses.  Through our proven laboratory informatics, digital quality & compliance, and scientific staffing services we deliver the highly specialized people, processes, and technology to fundamentally transform how science-based businesses operate.  Astrix was founded by scientists to solve the unique challenges which science-based businesses face in the laboratory and beyond.  We’re dedicated to helping our clients speed & improve scientific outcomes to help people everywhere.


Contact us today and let’s begin working on a solution for your most complex strategy, technology and staffing challenges.

Web developer Ibiut