Digital Transformation in Life Sciences with Validation 4.0

The turning points in industrial transformation history have been characterized by revolutionary-at-the-time tools: The first industrial revolution (1.0) used mechanized power by utilizing water and steam; then came the second (2.0), which enabled mass production through the use of electricity; and finally, the third revolution (3.0), which introduced computers and automation to production lines. These transformation periods marked by revolutionary technologies have contributed significantly to the rise in industrial productivity and efficiency.

Although the latest industrial revolution doesn’t feel too long ago, we’re currently at another turning point in history. Technologies such as connected devices and the Industrial Internet of Things (IIoT) have increased the availability and visibility of data, driving the fourth industrial revolution (Industry 4.0).

In today’s consumer world, smart and connected technologies are easy to find. For example, automated digital assistants like Google Nest, Siri, or Alexa communicate with IoT-connected products, such as smart thermostats or smart blinds, to carry out the commands of the user.

The pharmaceutical industry has historically been slow to adopt new technologies, but that’s beginning to change. The International Society for Pharmaceutical Engineering (ISPE) has applied many of the guideposts associated with regulated industries — such as the International Conference on Harmonization (ICH) guidelines — to the Industry 4.0 foundation to illustrate an operating model, called Pharma 4.0, for achieving the promises of this latest revolution.

The Pharma 4.0 Operating Model is the Pharma and Biotech industries’ interpretation of Industry 4.0. It provides a practical operational framework that enables rapid adoption of new technologies in a highly regulated environment.

The Pharma 4.0 Operating Model provides the foundation for four elements that pharmaceutical companies consider to be the pillars of digital transformation — required to fully realize the promises of Pharma 4.0.

This operating model clearly shows that 4.0 is not just a technology initiative; the cultural, process, and resource changes must also be addressed.

Digital transformation provides several benefits, such as boosting productivity, error-proofing workflows, and improving data management. However, when pharmaceutical manufacturers realize that they’ll have to validate these new systems, adoption conversations come to a standstill.

Validation requires manufacturers in highly regulated industries to establish documented evidence to assure that a specific system, equipment, computer system, or process satisfies its intended use consistently and reliably.

Validation has traditionally been a time-consuming process that has largely remained unchanged in the past decade, despite the increased functionality and sophistication of computerized systems. If validation practices aren’t updated, there may be significant delays in the deployment of computerized systems.

Tulip understands that the traditional approach to validation does not make sense in an increasingly digital world. Here, we’ll discuss how you can adopt a Validation 4.0 approach to adopt new technologies while ensuring compliance.

Here are some aspects to consider prior to adopting Validation 4.0:

Quality by Design (QbD)

Tulip is a platform where app builders are able to develop apps and iterate quickly without needing to write a single line of code. With so much flexibility, it’s important to integrate QdB into the product development process.

Process experts are best suited for this role. These experts should collaborate with your quality team to define risk mitigation strategies around your most critical aspects, iteratively — starting at the beginning of your product development cycle to ensure your processes remain controlled.

Data Integrity by Design

With the utilization of new technologies, creating data centric-approaches that have high data integrity is the foundation of Validation 4.0. Data is visible and available to more people across the value stream, and interactions between various data sets happen more frequently. Organizations must ensure the data they capture is high-quality so they can make sound decisions.

Integrated Environments

Pharmaceutical manufacturing environments are incredibly data-rich. Edge computing has enabled data from many endpoints to be captured, visible, and available across the entire value chain. With increased transparency, pharmaceutical companies can make decisions faster and gain greater agility.

Modern Documentation

Modern documentation empowers you to go beyond the process of collecting data on a piece of paper and translating that static data into a digital system. Now, data can be automatically stored and pulled at any given moment. So much of today’s data documentation is digitally native, allowing you to rely on technical controls to capture automatically or do verifications for you.

Shifting Away From the “Document” Mindset

Let's talk about modern documentations in more detail. When we say documents, people traditionally think of paper, or in Industry 3.0, the electronic documentation of data or paper on glass.

But if we are to embrace the fourth industrial revolution, we need to shift our focus to how data is captured and how it’s controlled. Using frontline operations platforms like Tulip, users can directly capture data in their apps by executing their process steps and generating the necessary “documented information” required by regulators. Documentation shouldn’t be a process laid on top of production: It should be seamlessly integrated into the production process itself.

Within a traditional approach (Pharma 2.0 or 3.0), operators look at each piece of equipment and go through the IQ, OQ, PQ process in a serial fashion. They then move towards a computerized system of IQ, OQ, PQ — and finally consider validating the process behind it.

However, Tulip’s flexible and agile platform opens up the possibility for validation to be completed with an integrated approach. This means that you can continue iterating and building new apps while keeping your operations running with existing apps, all while operating at full capacity. This shifts the focus to assuring your processes — and your data control strategies — are in place and effective.

Part of the integrated approach is identifying and setting the proper risk management strategy as part of your app development process. In the figure above, we show how a process and data flow can provide a meaningful foundation for risk assessment. Done iteratively, this allows you to design risk control strategies directly into your app building, and sets you up for value-added validation acceptance criteria. With Tulip, this data can be collected automatically from devices or sensors, collected manually from an operator, or sourced from an information system.

After mapping out your data flows, you can use Tulip to incorporate quality by design and data integrity by design principles into your apps. By doing so, you are setting the foundation for validation by execution and then verifying that your control strategy is in place and effective.

Seeing these aspects in the context of not only their data lifecycle but also their process gives us greater visibility into the potential vulnerabilities and criticalities of these types of data.

First, you can assess the vulnerability risk based on factors like the automation level, human interface, or manual data recording. This is a critical data point at which facilities need to maneuver high risk.

By taking the time to define which steps might be critical or require an additional risk mitigation step, you can build effective control strategies. All that’s left to do is to test your app against your validation acceptance criteria.

A huge benefit of Tulip is that every time you execute your apps, your data is stored in a record. This record builds evidence to verify your control strategies are effective — and validates your app.

In today’s increasingly digital manufacturing landscape, the traditional approach to validation no longer makes sense — as it ultimately delays the adoption of computerized systems.

By implementing a Validation 4.0 approach, pharmaceutical manufacturers can adopt new technologies while still ensuring compliance. Doing so requires quality by design, data integrity by design, integrated environments, and modern documentation.

Tulip’s platform enables an integrated approach in which app development can occur without interrupting the apps running your manufacturing operations. By incorporating risk control strategies directly into the app development processes, you can set the foundation for risk-based validation. Executing your app allows you to gather evidence and ensure your risk control strategies are in place and effective, thus validating your app.