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AI governance
Human-reviewed AI for evidence preparation
VigilySys can support drafting, mapping, and gap identification workflows, but regulated outputs require human review and accountable decision-making.
AI is assistive
AI-assisted outputs should be reviewed, accepted, edited, or rejected by responsible users. The system should support traceability and evidence ownership rather than black-box decisions.
Controlled evidence context
AI-supported workflows should operate on controlled project context, not uncontrolled public prompts or patient data.
Boundaries
AI support does not replace regulatory judgement, clinical evaluation, cybersecurity testing, privacy assessment, or quality-system approval.
Common questions
Does VigilySys make regulatory decisions automatically?
No. VigilySys supports evidence preparation and traceability. Device-specific regulatory decisions remain with responsible professionals and authorities.