Digital Validation and Why It’s Important to Pharmaceutical and MedTech Manufacturers

Modern technologies make it possible to create digital simulations, digital twins, and virtual 3D models of products, parts, manufacturing processes, machine processes, systems, and more.

Engineers can then use these simulations and models to facilitate the design process, improve quality, identify errors, and improve performance. They can do this by testing multiple design variations in multiple environments under multiple conditions.

For many industries, including pharmaceutical and medical device manufacturing, this is a game-changer.

However, what happens if the digital simulation is incorrect or inaccurate? Of course, the answer is the results produced by the simulation or model will also be incorrect or inaccurate.

Enter digital validation.

Digital validation is a process that, in simple terms, ensures the accuracy and correctness of digital simulations and models.

This gives everyone, from engineers to decision-makers to end-users, confidence. Confidence not only in the simulation or model but also in the real-world outputs that result, i.e. outputs such as product design changes, changes to processes, etc.

The Importance of Digital Models and Simulations

The digital modelling tools that are currently available make it possible to create powerful thermal, mechanical stress, injection moulding, computational fluid dynamics, and circuit simulations in a virtual environment.

This can help determine things like the best materials to use in a product, for example, or the design and shape of various parts. It’s also possible to use simulations to identify failures that occur over time, i.e. failures that are hard to identify with a physical prototype.

Furthermore, digital models of products, parts, processes, or systems can be simulated in various environments and under a range of different conditions.

This provides engineers with accurate data to make decisions so eliminates common issues that can cause problems, such as making educated guesses or over-engineering products.

Benefits of Digital Models and Simulations

The potential benefits of digital models and simulations to manufacturers in the pharmaceutical and medical device industries are substantial. They include:

  • Reduced time to market for new products because design changes can be implemented and tested in a virtual environment speeding up the iterative process
  • Reduced costs at all stages of a product’s lifecycle but particularly in the product design stage as digital simulations and models are highly effective at avoiding downstream design changes
  • Improved quality of existing products
  • Improved OEE and manufacturing productivity
  • Helps ensure regulatory compliance and streamlines compliance processes, particularly when getting approval for a new medical device

The Need for Digital Validation

Creating a digital simulation of a product or part is not enough, however, particularly in highly regulated industries like pharmaceutical and medical device manufacturing. This is because each stakeholder in the process, from company decision-makers to regulators to end-users and patients, needs to know the simulation, and the results it produces, are correct.

Also, while the technology that exists today is extremely powerful and can now produce virtual models that are very close to being exact replications of real-world products, parts, and processes, close to exact is not the same as exact.

The existing paper-based process for validation of existing products, parts, manufacturing processes, machine processes, and systems is extremely time-consuming, labour intensive, and inefficient, and will potentially negate the benefits of digital models and simulations.

As a result, a new approach for the validation of digital models for their intended purpose is essential.

How Digital Validation Works

Digital validation is an iterative process that happens during the development of the simulation. Since the digital simulation of a product or part is available during the design stage of the project, digital validation can begin at this stage. Test simulation models can be built to test the user requirements and verify that these requirements are being met. These test simulation models are automatically updated with any changes to the model and can be re-executed at any time to verify that the model still meets the original user requirements. The digital validation process ensures, confirms, and quantifies the accuracy of the simulated model.

This could be accuracy compared to the real-world product, part, process, or system. It could also be accuracy compared to the conceptual description of the model or accuracy compared to experimental data.

The digital validation process significantly reduces the level of effort involved to qualify products, parts, manufacturing processes, machine processes, and systems, which, in turn, significantly reduces the associated validation costs.

Typically, the validation process ensures the simulated model is accurate within an acceptable range for the intended purpose of the model. Therefore, it’s important to create simulated models for a specific purpose.

Maximising Benefits

So, in summary, digital models and simulations provide significant opportunities for pharmaceutical and medical device companies while digital validation ensures the validity of those simulations, giving them measurable and fully documented credibility while also making validation more efficient and affordable.

Dermot McMorrow

Dermot is SL Controls' Compliance Director. He is responsible for the company's quality management systems and maintaining high compliance standards. Dermot is a validation specialist and has extensive experience leading validation projects for clients in Ireland and internationally, particularly in the multinational pharmaceutical and medical device sectors.

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