The future of validation in life science
Insights from Henrietta Vinnerås, Senior Advisor and QA Manager at AFRY
As the Life Science industry becomes increasingly automated and data-driven, new demands arise for how we ensure quality and patient safety. Validation, once a steady but heavy process, is now evolving into something both smarter and more dynamic.
One of the people driving this development is Henrietta Vinnerås, Senior Advisor and QA Manager at AFRY. With over 25 years of experience in industrial microbiology, cleanroom processes, and quality management, she helps companies find the balance between regulatory assurance and innovation. In this article, Henrietta shares her insights on how validation can evolve to meet the industry’s future demands.
When validation moves from tradition to innovation
Many Life Science companies know the scenario: after months or even years of a major capacity-expansion project, the new, highly automated filling machine is finally installed in the cleanroom. Expectations are high, and the team is eager to integrate the equipment into regular production. But before the machine can go live, one crucial step remains – ensuring that it works for its intended use.
Validation is a cornerstone of the Life Science industry, ensuring that processes, systems, and equipment function as intended and meet regulatory requirements. But as technology advances and efficiency demands increase, validation strategies have also begun to shift. We are now facing a paradigm shift where traditional methods are being complemented, or replaced, by more flexible, risk-based approaches such as lean validation.
Quality-assured validation – A foundation of regulatory confidence
In the EU, validation in pharmaceutical manufacturing is governed by GMP (Good Manufacturing Practice), particularly Annex 15, which outlines principles for qualifying and validating equipment, processes, and systems. Validation must demonstrate that a process consistently delivers results that meet predefined specifications and quality requirements. There are also other guidelines, such as the FDA’s regulations for products intended for the U.S. market.
Traditional validation structures such as the V-model provide a robust framework for quality assurance but can be resource-intensive and perceived as rigid. This has prompted the industry to explore alternative methods that maintain quality assurance while increasing efficiency.
Lean validation as a scientific and risk-based approach
Lean validation is based on the principles of ICH Q9 and ASTM E2500, emphasizing scientific understanding and risk assessment to guide validation efforts. Instead of validating everything in the same way, focus is placed on what has the greatest impact on product quality and patient safety. This ensures that resources are used where they truly matter – an approach now encouraged by many regulatory agencies. The same philosophy is reflected in GAMP5 and other guidelines from ISPE.
The FDA’s CSA (Computer System Assurance) initiative for medical devices can replace traditional CSV (Computer System Validation) with a more adaptable, risk-based method. The focus is on validating what is critical and assessed as high-risk. If a function has a high risk, it requires more rigorous testing, while low-risk functions do not need the same level of scrutiny.
Risk assessment as the foundation of everything
Regardless of the validation method, a well-executed risk assessment is essential. It helps identify critical control points, define the validation scope, and ensure that the appropriate level of verification and testing is applied. By integrating risk management throughout the validation process, we create more dynamic and sustainable quality assurance. A well-documented risk assessment also serves as a strong decision-making tool.
In short, risk-based validation means that we:
- Identify and assess risks to product quality and patient safety
- Use scientific understanding and existing knowledge
- Tailor validation activities according to risk level
- Document decisions, rationales, and actions taken
Leveraging for smarter validation
Another important aspect of modern validation is the ability to reuse tests and data, known as “leveraging.” By using previous validation results, such as supplier documentation or earlier qualification phases, we can avoid duplicating work without compromising quality.
It’s important to understand that this does not mean taking unauthorized shortcuts. On the contrary, it’s about using existing knowledge in a structured and documented manner, fully aligned with regulatory expectations. For example, if all material certificates for the surfaces of a filling machine have already been reviewed by the supplier, we don’t need to verify them again when the machine arrives. We only need to ensure that the certificates are included in the machine’s documentation package.
Confidence through smart and innovative validation
Validation is not a barrier. It’s an opportunity. By combining traditional methods with modern, risk-based strategies, the Life Science industry can achieve high quality, regulatory compliance, and operational efficiency. Lean validation, test reuse, and risk-based documentation are not dangerous shortcuts, they are smart tools for meeting the demands of the future.
Daring to think differently about validation isn’t just allowed – it’s necessary. Are you ready to propose lean validation for your next project?
