Introduction
For decades, the validation industry has relied on paper-based methods. The advent of paper on glass solutions marked the first significant leap toward digitizing these processes. Yet, as we have seen in the last two to three years, the transition has accelerated—but not without challenges.
The Challenges of Traditional Validation
Traditional validation approaches have long been burdened with inefficiencies. Many in the industry have adhered to what might be termed "make work" validation. Extensive paperwork (or its digital equivalent) has often been produced without a solid foundation explaining why such documentation is necessary. This approach, while historically ingrained, has resulted in redundant and arduous processes that slow innovation and delay the delivery of life-saving products.
The Paradox of Paper on Glass
The shift from paper to digital, colloquially known as paper on glass, is paradoxical. On one hand, it promises increased efficiency and streamlined workflows; on the other, it risks replicating the bad habits of the past. Many digital validation tools have been designed to mimic word processors rather than rethinking validation entirely. As a result, they often apply outdated GXP-centric workflows that impede progress rather than enhance it.
Rethinking Validation: A Risk-Based Approach
For years, the FDA's "least burdensome approach" has been either misunderstood or overlooked by many in the industry. Despite the presence of critical guidance within frameworks such as GAMP5 2nd edition, there has been a disconnect between risk-based principles and their practical application. Instead of removing paper from the process and simply digitizing legacy habits, the industry must adopt truly innovative solutions that leverage modern technology.
Lessons from the FDA and the GAMP Community
Having been part of the GAMP community for over 20 years, I have witnessed the evolution of validation practices firsthand. The current iteration of GAMP5 emphasizes critical thinking—a call to move away from rote processes and towards a more thoughtful, intended-use focused approach. The work of the FDA/FICSA team, despite early skepticism on my part, has highlighted many entrenched practices that hold back the full potential of risk-based validation.
Introducing Valkit.ai and CSAI
In response to these challenges, Valkit.ai was designed with a fresh perspective. We recognized that digitization should not merely replicate the old paper processes but should enable dynamic, risk-driven validation. By listening to the FDA FICSA team, the GAMP community, and the insights of our advisory board, we developed CSAI—a groundbreaking feature that leverages our proprietary RAG framework.
CSAI empowers users to create risk-responsive test scripts dynamically, embodying the FDA's least burdensome approach while accelerating the validation process. This innovative capability allows organizations to shift away from obsolete practices and truly harness the power of digital transformation.
Conclusion
Paper on glass was a crucial first step in the journey towards digital validation, but it is far from the final destination. As the validation landscape continues to evolve, embracing a truly risk-based, digitally enabled approach is essential. With Valkit.ai, organizations can finally break free from the constraints of legacy validation processes and move toward a future where compliance and innovation go hand in hand.
Experience the transformation for yourself and see why Valkit.ai is the most powerful digital validation tool on the market.
