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Need a Validation Concept to Verify Your Process? Ensure Your Standards With Ellab

Need a Validation Concept to Verify Your Process? Ensure Your Standards With Ellab

How simple validation concepts can verify and support even your most complex processes

Jacob Krifstoffersen

Ellab Nordic’s GMP consultancy department was recently contacted regarding the application of an AI-based system intended to replace the daily manual inspection process of a client’s busy site. We were assigned the exciting task of developing a reliable validation concept that could verify if the AI-based process would be fit for purpose.

Simple Is Smart

We often see examples of technology specialists who develop overly complex validation concepts, which can be impossible for the QA or auditors to understand. Their in-depth knowledge can be incorrectly applied and end up causing difficulties when attempting to explain how they are proving the system’s capabilities.

Ellab has decades of experience within the engineering and validation field, and we are grateful to have been heavily involved with the process of moving the industry towards a scientific and risk-based validation paradigm. We take pride in the development of simple concepts which are still capable of proving complex processes.

Validate Your Future

After clarifying the necessary critical process parameters, we were able to develop a validation concept based upon industry standards, with clear acceptance criteria. QA were pleased to find that they were easily able to understand the system’s validation requirements and were now fully convinced that they would be able to explain and rationalize the concept and its results in future audits.

As a further benefit, we were able to develop the validation concept to be application-focused, and therefore technologically agnostic. This greatly benefitted the project because even if their current technology was to fail, it would still be possible to quickly and efficiently test a series of alternatives or developments that may have been a better fit for purpose.

Prove Your Process

Does the complexity of your process or validation concept make it difficult to prove that you are meeting regulatory standards?

At Ellab, we can help you ensure that all your processes are compliant, and we thrive on simplifying the validation of complex processes. This ensures that QA’s and regulatory bodies can appropriately scrutinize the data and ensure that the end-product is safe and consistent.

Need help finding a validation concept that works for you?

Learn more about Ellab’s specialist GMP  and engineering services.

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