Inside Graniten’s Validation Team

At Graniten, validation is far more than a checklist, it is a mindset, a process, and a promise.

Our Validation Department plays a central role in ensuring that every machine we deliver meets customer expectations, regulatory requirements, and ultimately, the highest standards of patient safety.

Together with our project team and the customer quality team, we work side-by-side to build solutions that are not only functional, but proven, transparent, and trustworthy. 

Starting Early: Requirements That Drive the Entire Journey

One of our strongest principles is simple – First time right! 

We begin validation early by defining and refining requirements together with the customer. Customer needs are translated into measurable system and technical requirements that guide FAT, SAT, and further qualification activities. 

Already in the quotation process we ensure that every requirement is read, understood and challenged if needed. 

By validating early we close up to 20% of requirements before the machine is even fully built and create clarity, reduce risk, and shorten the later testing phases. 

Smart Testing: Simulation, Standardized Methods and Longer Test Periods 

Graniten’s Validation team uses well-established, generic test methods that have been refined over many years. These methods help reduce administrative time while maintaining full traceability and regulatory robustness. 

We work with: 

• Simulations to verify logic and expected behaviour early. 

• Pre-FAT testing, which starts as soon as the machine is operational, giving us longer test periods that capture changes and ensure stability. 

• Breakdown of large tests into smaller, transparent deliverables, providing customers clear visibility of progress. 

This approach brings efficiency and confidence. Customers can follow along, see the results, and feel assured that every step is controlled. 

Agile Adaptation: Meeting Customer Needs With Flexibility 

Every customer is unique and so are their quality processes. Our team stays agile, adapting our methods to fit customer expectations while maintaining GMP-compliant validation practices.  

We provide complete FAT protocols, support both on-site and digital FATs, and bring operators, QA, and engineering teams together in a structured but flexible setup.  

Upon request we can also conduct fully digital FATs with cameras and remote walkthroughs.  

A Transparent Customer Journey 

Transparency is the foundation of trust. From early requirement handling through FAT, SAT, and customer qualification phases (IQ, OQ, PQ), transparency is key. Customers are actively involved, gaining deep knowledge of the machine, often turning validation into a valuable training opportunity and shortening the customers later qualification process (IQ, OQ). 

We are also able to support and execute customer validation phases as a complete end-to-end service. 

The People Behind the Process 

Our validation engineers bring decades of experience from quality, testing, and validation roles, with strong roots in different industries. Their technical expertise and analytical mindset ensure robust, reliable, and efficient validation processes. 

“Best part of the job is finding smarter solutions, improving processes, and solving interface questions between mechanics and automation”. 

says our Validation Engineer, Anton Risgaard. 

“The greatest reward is standing alongside our customers during testing and seeing their confidence in the final result” 

says our Validation Engineer, Thomas Fritzon

Every delivery at Graniten is a shared achievement proof that handling requirements early, applying smart testing methods, and collaborating closely with our customers leads to success. Our Validation Department ensures that every machine meets the highest standards of quality, compliance, and patient safety, while keeping the customer involved, informed, and confident throughout the process.

Want to learn more and see how Graniten can support you?

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