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GDP, GMP, GAMP 5, MDR, ISO 13485, Annex 11, the upcoming Annex 22 and now the AI Act too: the rules keep piling up, and staying demonstrably in control costs more time, money and energy every year. RealAxces makes that (Quality) work lighter. Frank van Zutphen worked for thirty years in the pharmaceutical and medical devices industry, as a Qualified Person and Responsible Person GDP. He is inspired by AI and always open to innovation that makes the work simpler, better and more enjoyable for everyone, with people first. He does this with and without AI. He applies AI exactly where it earns its place, with the source behind every finding and a person who signs off. Where a clear procedure or a good conversation does more, that's what he chooses. He follows the AI Act closely, and is glad to think along about how it fits with the GxP rules a company already works with. For pharmaceutical companies and their suppliers with GxP obligations. If something in your work is more cumbersome than it should be, Frank would be glad to think it through with you: Frank@RealAxces.nl.

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Frank van Zutphen is the Founder and Principal — RealAxces AI Compliance Platform of RealAxces.

1 people are employed at RealAxces.

RealAxces is based in Amersfoort, Utrecht.

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