MODULAR
Built for your workflow
Deploy only what you need, when you need it
INFRASTRUCTURE
European sovereign AI platform
Built on proven open-source technologies and validated within a GMP development framework. Every component meets European standards and Digital Act requirements.
Hosted in Europe
OVH Cloud infrastructure ensures your data stays within European borders. Complete sovereignty over your quality management systems and manufacturing records.
European AI engine
Mistral AI powers our language models. No reliance on external cloud providers or non-European infrastructure for your critical operations.
Digital Act compliant
Full compliance with EU regulations and pharmaceutical data protection requirements. Transparent, auditable AI that regulators understand and approve.
Real impact
From quality managers who know the work
"NEX22 gave us back hours every week. The batch record review module catches what we'd miss, and we stay in control of every decision."
Anna Bergström
Quality Manager, Pharma
"We integrated it in weeks, not months. No rip-and-replace, no chaos. It just worked alongside what we already had."
Marcus Chen
Operations Director, Manufacturing
"The SOP drafting module is like having an expert on staff. It understands our standards and writes the way we need it to."
Elena Rossi
Compliance Lead, Quality
FAQs
Everything you need to know about NEX22 and how it works.
When are modules available?
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Document Control and Batch Record Review launch Q1 2026. Predictive Deviation Analysis follows in Q2, with Ecosystem Interfacing ready by Q3 2026. We're building this right, not fast.
Does it replace my QMS?
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No. NEX22 reinforces your existing quality management system. It enhances data handling and risk assessment while keeping your Quality Manager in total control of decisions.
What systems does it integrate with?
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Our Ecosystem Interfacing module supports Werum PAS-X, Rockwell PharmaSuite, Siemens Opcenter, and Veeva Vault QMS. We're expanding this list based on client needs.
Is it GMP compliant?
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Yes. Every module is validated within our GMP development framework. We meet pharmaceutical standards from the ground up, not as an afterthought.
Where is my data hosted?
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OVH Cloud in Europe. Your manufacturing records and quality data never leave European infrastructure. Full Digital Act compliance, no exceptions.
CONNECT
Get in touch
Talk to our team about your quality management challenges and how NEX22 can help.