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RGDS — Regulated Gate Decision Support
Copyright © 2026 Mark Julius Banasihan
This repository contains an independent, non-commercial reference implementation
demonstrating decision-governance patterns for regulated, phase-gated environments.
RGDS is provided for research, educational, and illustrative purposes only.
It does not constitute regulatory advice, compliance guidance, or an approved
delivery framework.
All decisions, interpretations, and uses of this material remain the sole
responsibility of the adopting organization and its authorized decision-makers.
DISCLAIMER OF WARRANTIES AND REGULATORY STATUS:
This framework is not endorsed, approved, or validated by the U.S. Food and Drug
Administration (FDA), European Medicines Agency (EMA), or any other regulatory
authority. It represents independent research and industry best practices compiled
from publicly available guidance documents and professional experience.
Organizations implementing RGDS are solely responsible for ensuring compliance
with all applicable regulatory requirements in their jurisdictions.
THIRD-PARTY CONTENT:
This work references and cites various regulatory guidance documents, industry
standards, and published research. All such references remain the property of
their respective copyright holders and are used for educational and analytical
purposes under fair use principles.
Licensed under the Apache License, Version 2.0.
See the LICENSE file for details: http://www.apache.org/licenses/LICENSE-2.0