XyReg Cortex AI
Cortex is the AI layer built into XyReg. It drafts regulated content, answers questions grounded in your own quality system, and removes the copy-paste work that normally goes to consultants.
What Cortex can do
- Draft SOPs, work instructions, risk analyses and design documents from your device profile.
- Summarise a dossier section and highlight missing evidence against MDR or FDA expectations.
- Answer natural-language questions about your own QMS, citing the exact document and revision.
- Suggest CAPA wording, complaint classifications and vigilance decision rationales.
- Respond in Slack so the team can query the quality system without leaving their workflow.
Human in the loop, always
Cortex never approves or releases anything. Every AI-generated item enters the system as a draft that a named, qualified user must review and sign. The audit trail records that the content was AI-assisted and who approved it.
Data sovereignty
Cortex runs on EU-hosted infrastructure. Your data is never used to train third-party foundation models, is never shared between tenants, and prompts and outputs are retained only inside your workspace.