Pharma IT Insights
Driving Consistency in Validation Across Complex CAPEX Projects
By Rojan Demirtas
June 16, 2026
This article was originally featured in Pharma Tech Outlook Europe and is reproduced here for our readers.
Pharma IT Insights
Driving Consistency in Validation Across Complex CAPEX Projects
By Rojan Demirtas
June 16, 2026
This article was originally featured in Pharma Tech Outlook Europe and is reproduced here for our readers.
The Quiet Shift Redefining CQV Practices
The approach to CQV has undergone a significant transformation in recent years. Traditionally, the process was dominated by extensive documentation, rigid adherence to IQ/OQ/PQ templates, and a one-time validation conducted at the initial system implementation stage, with minimal reliance on suppliers.
Today, however, the industry is embracing a risk-based methodology, where critical thinking and well-founded justifications drive the validation process. This shift places greater emphasis on continuous life cycle assurance and encourages the strategic use of supplier documentation, all while maintaining the highest standards of patient safety, product quality, and data integrity. By adopting these modern practices, organisations are better equipped to respond to evolving regulatory requirements and sustain robust quality systems throughout the product lifecycle.
Overcoming Fragmentation in Large-Scale CAPEX Projects
From my experience, there are several challenges when working on complex CAPEX projects where equipment, systems, and hardware must be fully aligned and integrated. Such projects typically involve multiple packages across different disciplines, with teams operating in parallel but often with differing methods, perspectives, and ways of working.
A key objective is to ensure alignment across all stakeholders on the validation and test strategy clearly, unambiguous, and consistently interpreted. However, since these projects are ultimately driven by people, variations in interpretation and understanding are inevitable. As a result, differences in culture, work ethics, and overall understanding can present significant challenges in achieving full alignment.
Another common challenge arises when a strong quality mindset has not been established from the outset. This can lead to downstream consequences, including deficiencies in design quality, incomplete or inconsistent documentation, and ultimately ineffective testing, as testing is typically executed against approved requirements and design specifications.
These risks can be mitigated through structured training and onboarding. Importantly, this should not be treated as a one-time activity, but rather as a continuous process of reinforcement to ensure that quality principles and project expectations remain consistently embedded in the mindset of all project participants
Enhancing Quality Outcomes Through Risk-Based Focus
Adopting a risk-based approach has become fundamental, rather than merely recommended, in GMP validation and qualification processes. Regulatory authorities now clearly identify this methodology as the cornerstone for both achieving compliance and enhancing operational efficiency. Modern regulatory frameworks are deliberately designed around the principle that not every aspect of a system or process warrants the same level of validation.
“While strategies and plans will naturally evolve over the course of the project, it is crucial to have solid fundamentals in place early on.”
In practice, organisations are expected to prioritise resources and focus efforts on critical areas, rather than attempting to validate every element uniformly. This strategic approach not only streamlines workflows but also ensures that attention is placed where it will have the greatest impact on patient safety, product quality, and data integrity.
Validation in the Age of Cloud and AI
I believe couple of trends such as the regulatory authorities stand points on CSV. The FDA CSA framework explicitly moves validation from static, document heavy CSV towards, risk-based assurance, continuous lifecycle validation, critical thinking over scripted testing. Validation will become continuous instead of project-based, embedded in systems lifecycle operations and driven by ongoing evidence generation.
Practically, less “validate then release” and more like “validate continuously while operating”. Additionally, the fully acceptance of cloud-based SaaS validation models across the regulators. Also, the strong integration of AI/ML into GMP systems, Authorities are increasingly focused on AI governance in regulated environments.
The Power of Getting the Fundamentals Right Early
Engage all relevant stakeholders right from the outset of the project. Establish a clear control strategy during the early phases, such as the conceptual and basic design stages, and outline the primary framework for your approach.
While strategies and plans will naturally evolve over the course of the project, it is crucial to have solid fundamentals in place early on. Laying this groundwork ensures that, as the project grows more complex, you are well-prepared to navigate challenges and adapt effectively to any changes that arise.
💡 If you need support with CQV, CSV, CSA, or complex GMP CAPEX projects, our experienced consultants are ready to help you deliver compliant, risk-based validation strategies with confidence.
About the author
Rojan Demirtas is Director of Manufacturing and a Consultant at Pharma IT with more than 6 years’ of experience in the pharmaceutical industry working with GMPcompliance, implementation of procedures and processes in manufacturing settings and working on qualification and validation projects of equipment and systems for packaging operations, wash & sterilization operations and IT/OT systems.
