GMP COMPLIANCE
Regulatory certainty in an AI-driven world
NEX22 is built from the ground up to uphold Current Good Manufacturing Practices and the upcoming Annex 22 guidelines for Artificial Intelligence. We don't compromise on compliance.
FOUNDATION
The pillars of compliance
NEX22 stands on three pillars of regulatory excellence, each one tested and proven in the most demanding environments.
GAMP 5 framework
Developed in strict accordance with GAMP 5 principles for computerized system validation and lifecycle management.
ISPE commitment
As an active member of ISPE (France Chapter), we closely monitor and implement regulatory advancements in the Life Sciences sector.
EU digital act
Fully compliant with the European Digital Act, ensuring a sovereign, ethical, and transparent AI framework.
Anticipating Annex 22 for pharma
Our platform is specifically designed to align with the forthcoming GMP Annex 22 requirements. We are committed to the new standards of algorithmic governance in pharmaceutical quality management.
INFRASTRUCTURE
Where your data lives matters
Data sovereignty is not optional in pharmaceuticals. European-hosted infrastructure ensures complete regulatory responsibility.
Sovereign hosting
European developed and European hosted infrastructure. We prioritize Mistral AI and OVH Cloud to reinforce data sovereignty and confidentiality.
Validated framework
All open source AI components are integrated within a validated, GMP compliant development framework, ensuring precision under intensive use.
Transparent operations
We document every decision, every update, every validation step. Transparency isn't a feature; it's how we work.
Continuous assurance
Regular audits and proactive alignment with evolving EU regulatory expectations keep your systems ahead of change.
Compliance is our foundation
Request our detailed Compliance Whitepaper to see exactly how NEX22 meets today's standards and anticipates tomorrow's.