Process Validation: From Regulatory Burden to Stratgic Advantage

Jesper Wagner from NIRAS is a member of the ECA Validation Group. He has published an article in the online journal “Pharmaceutical Online” on the topic of “Process validation rethought: From mandatory requirement to strategic competitive advantage.” Is it worth reading this article? Yes, it is. It is among the top 10 most-read articles of 2025 on Pharmaceutical Online. Below is a summary.

Process Validation Revisited: From Regulatory Burden to Strategic Advantage

Process validation is still often viewed in pharmaceutical and medical device companies as a costly regulatory obligation. This mindset leads to underinvestment, weak execution, and avoidable risk. The article by Jesper M. Wagner argues that, when done properly, process validation is a strategic investment with clear business value.

Beyond compliance, validation ensures stable, reproducible processes, reduces deviations and scrap, and accelerates time-to-market. As a data-driven discipline, it builds deep process understanding, supports scale-up and technology transfer, and enables better decision-making. This is especially evident when considering the Cost of Poor Quality (COPQ), which in pharmaceuticals can reach 25-40% of turnover-highlighting the large savings potential of robust validation.
Effective validation enables faster product launches, smoother global expansion through reuse of validation data, and improved manufacturing performance metrics such as overall equipment effectiveness (OEE), utilization, and cost of goods. At the same time, it significantly reduces regulatory risk. Poor validation remains a major cause of deviations, inspection findings, recalls, and regulatory actions, with the cost of noncompliance often several times higher than the cost of proper validation.

Common shortcomings include poorly designed protocols, insufficient documentation, lack of worst-case testing, and weak risk management. Management therefore needs to elevate process validation to a core business discipline by integrating it into strategy, investing in skilled resources, fostering cross-functional collaboration, and measuring ROI with meaningful KPIs.

Conclusion

Process validation is not a sunk compliance cost but a value-generating activity. When treated strategically, it becomes a source of competitive advantage. The key question is no longer "What does validation cost?" but "What is the cost of poor quality?

Here you can read the whole article.