Quality Management

Validation 4.0 – The Benefits to the Life Sciences Industry

Quality Management

November 19, 2021

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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.

The Benefits of Validation 4.0

Validation 4.0 ensures new technologies are adopted and validated to meet patient safety and product quality criteria and follow the Pharma 4.0™ operating model. Given that Validation 4.0 enables Pharma 4.0™, there are a number of benefits that Life Sciences organization will see including:

  • Improved Quality – By focusing on the critical thinking and the risk management required to validate the various technologies like smart devices within the ecosystem, it assists in ensuring optimal quality is met. The validation includes visibility into the data exchanged through support networks of suppliers, CDMOs, CMOs, and other external organizations that are part of the value chain.  By incorporating the guidelines of Validation 4.0 organizations can ensure a high level of data integration across the organization as well as with suppliers. It can also enhance visibility and resiliency of the value chain.


  • Lowers the Cost of Operations –  In leveraging new technologies as part of the Pharma 4.0™ framework and incorporating the guidelines of Validation 4.0, the organization can lower the overall cost of Quality across the organization.


  • Lowers the Risk By leveraging Validation 4.0 strategies, the organization can also lower the overall risk. By incorporating the new technologies of Pharma 4.0™ and leveraging Validation 4.0 guidelines the organization can better mitigate risk. This requires an approach that focuses 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 control and mitigate risks throughout the process.


  • Provides a Faster Time to Market Validation 4.0 also assists in helping the organization to get products out to market faster. By leveraging technologies of Pharma 4.0™ and the Validation 4.0 guidelines, the organization can better control the quality and safety in real-time and manage any deviation, thereby augmenting a faster time to market of products.
  • Better Visibility Across Value Chain By incorporating the new technologies of Pharma 4.0™  along with the guidelines of Validation 4.0, the organization will have a complete and concise view across the value chain in order to ensure better control of the various internal and external processes.


By leveraging the guidelines of Validation 4.0 the Life Sciences organization can receive significant benefits. It can improve quality of the products along with  lowering the cost of operations. There will also be a lower risk given the focus on controls throughout the value chain and at various phases to continuously check for issues. Additionally, the organization will have a quicker time to market by leveraging new technologies and Validation 4.0. Another significant benefit, will be the visibility across the value chain to ensure things are running smoothly from both an  internal and external perspective.

Why it Matters to You

When implementing any new technology or guidelines, it is critical to understand the benefits you will receive by doing so. Validation 4.0 is a key component of Pharma 4.0™ and will provide significant benefits to any Life Sciences organization. In this blog we discuss:

  • The key benefits of Validation 4.0 to the Life Sciences organization.
  • How the organization’s product quality and product safety are impacted.
  • How it lowers the cost of operations and the risk level.
  • How it improves the time to market and visibility across the value chain.

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.

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