The J&J engagement is expected to include a GxP addendum to the MSA; PYRANA will not be positioned as a validated GxP system but as a decision-support and knowledge retrieval tool used by qualified personnel.

J&J's legal and regulatory teams are clear that PYRANA must not be classified as a validated system for its initial use case. The GxP addendum will document PYRANA's role, data flow, and the human-in-the-loop review requirements that keep regulatory accountability with J&J's qualified personnel.