{ "format": "regforge-public-page-index", "version": 1, "note": "RegForge-specific index of public website pages. Not a standard agent protocol. Canonical URLs point to the human pages.", "site": { "name": "RegForge", "url": "https://regforge.ai/", "summary": "RegForge is a regulatory operating system for life-sciences teams: one connected system of record for validation, quality management, regulatory and clinical workflows, and AI governance. Its dAIn (Deterministic AI Network) layer, the regulatory intelligence layer in RegForge, assists with drafting, mapping, traceability and review while qualified people retain approval and signature decisions." }, "exports": { "llms_txt": "https://regforge.ai/llms.txt", "index_json": "https://regforge.ai/agent/index.json", "agent_home": "https://regforge.ai/agent" }, "pages": [ { "title": "RegForge: the regulatory operating system for validation, quality and AI governance", "summary": "RegForge is a regulatory operating system for life-sciences teams: one connected system of record for validation, quality management, regulatory and clinical workflows, and AI governance. Its dAIn (Deterministic AI Network) layer, the regulatory intelligence layer in RegForge, assists with drafting, mapping, traceability and review while qualified people retain approval and signature decisions.", "canonical_url": "https://regforge.ai/", "agent_url": "https://regforge.ai/agent", "markdown_url": "https://regforge.ai/agent/index.md" }, { "title": "RegForge product facts", "summary": "RegForge is a regulatory operating system for life-sciences teams: one connected system of record for validation, quality management, regulatory and clinical workflows, and AI governance. Its dAIn (Deterministic AI Network) layer, the regulatory intelligence layer in RegForge, assists with drafting, mapping, traceability and review while qualified people retain approval and signature decisions.", "canonical_url": "https://regforge.ai/product-facts", "agent_url": "https://regforge.ai/agent/product-facts", "markdown_url": "https://regforge.ai/agent/product-facts.md" }, { "title": "FDA CSA validation software for risk-based assurance", "summary": "Computer Software Assurance (CSA) is FDA's risk-based approach to establishing confidence that production and quality system software works for its intended use. RegForge helps teams record intended use and risk, scale test rigor to that risk, capture evidence and keep requirements, tests and results traceable, while qualified people make every approval.", "canonical_url": "https://regforge.ai/solutions/fda-csa-validation", "agent_url": "https://regforge.ai/agent/solutions/fda-csa-validation", "markdown_url": "https://regforge.ai/agent/solutions/fda-csa-validation.md", "updated": "2026-10-15" }, { "title": "21 CFR Part 11 compliance software for electronic records and signatures", "summary": "21 CFR Part 11 sets FDA's requirements for trustworthy electronic records and electronic signatures. RegForge provides technical controls that support it, including unique sign-ins with multi-factor authentication, time-stamped audit trails, signatures bound to the exact record version, and archiving instead of deletion. Your procedures and system validation remain your responsibility.", "canonical_url": "https://regforge.ai/solutions/21-cfr-part-11-compliance", "agent_url": "https://regforge.ai/agent/solutions/21-cfr-part-11-compliance", "markdown_url": "https://regforge.ai/agent/solutions/21-cfr-part-11-compliance.md", "updated": "2026-10-15" }, { "title": "Oversee the AI-enabled services supporting your trials", "summary": "A sponsor workspace for understanding provider activities, reviewing evidence, and managing the changes and issues that need your attention. Sponsor Oversight is offered as a pilot: provider updates are entered manually today, and there is no automatic reporting from provider systems yet.", "canonical_url": "https://regforge.ai/solutions/sponsor-oversight", "agent_url": "https://regforge.ai/agent/solutions/sponsor-oversight", "markdown_url": "https://regforge.ai/agent/solutions/sponsor-oversight.md", "status": "Pilot offering: being developed with pilot partners. Not generally available.", "updated": "2026-10-16" }, { "title": "Knowledge Library", "summary": "Short, sourced answers to common questions about validation, quality and AI governance in regulated life-sciences work. Each article separates regulatory text, general workflow guidance and what RegForge itself does. Written by the RegForge team; not legal or regulatory advice.", "canonical_url": "https://regforge.ai/resources/library", "agent_url": "https://regforge.ai/agent/resources/library", "markdown_url": "https://regforge.ai/agent/resources/library.md" }, { "title": "What is a regulatory operating system?", "summary": "A regulatory operating system is software that keeps requirements, risks, tests, evidence, approvals and quality records connected in one governed system of record.", "canonical_url": "https://regforge.ai/resources/library/what-is-a-regulatory-operating-system", "agent_url": "https://regforge.ai/agent/resources/library/what-is-a-regulatory-operating-system", "markdown_url": "https://regforge.ai/agent/resources/library/what-is-a-regulatory-operating-system.md", "published": "2026-10-15", "updated": "2026-10-15" }, { "title": "How to build requirements-to-test-to-evidence traceability", "summary": "A step-by-step method for linking each requirement to the tests that verify it and the evidence those tests produced, with a worked hypothetical example.", "canonical_url": "https://regforge.ai/resources/library/requirements-test-evidence-traceability", "agent_url": "https://regforge.ai/agent/resources/library/requirements-test-evidence-traceability", "markdown_url": "https://regforge.ai/agent/resources/library/requirements-test-evidence-traceability.md", "published": "2026-10-15", "updated": "2026-10-15" }, { "title": "What belongs in a software validation evidence package?", "summary": "A checklist of the plans, executed records, reviews and approvals that typically make up a software validation evidence package, and how to keep it consistent.", "canonical_url": "https://regforge.ai/resources/library/software-validation-evidence-package", "agent_url": "https://regforge.ai/agent/resources/library/software-validation-evidence-package", "markdown_url": "https://regforge.ai/agent/resources/library/software-validation-evidence-package.md", "published": "2026-10-15", "updated": "2026-10-15" }, { "title": "How to assess the validation impact of a software change", "summary": "A practical method for deciding what to re-verify when software changes: identify what changed, follow the trace links, rate risk, and record the decision.", "canonical_url": "https://regforge.ai/resources/library/software-change-validation-impact", "agent_url": "https://regforge.ai/agent/resources/library/software-change-validation-impact", "markdown_url": "https://regforge.ai/agent/resources/library/software-change-validation-impact.md", "published": "2026-10-15", "updated": "2026-10-15" }, { "title": "Where AI assistance ends and human approval begins in validation", "summary": "How to divide work between AI drafting tools and qualified people in computer system validation, with a responsibility table and controls to look for.", "canonical_url": "https://regforge.ai/resources/library/ai-assistance-and-human-approval-in-validation", "agent_url": "https://regforge.ai/agent/resources/library/ai-assistance-and-human-approval-in-validation", "markdown_url": "https://regforge.ai/agent/resources/library/ai-assistance-and-human-approval-in-validation.md", "published": "2026-10-15", "updated": "2026-10-15" }, { "title": "How to evaluate AI governance software for regulated teams", "summary": "Criteria and questions for choosing AI governance software in regulated life-sciences settings: inventory, risk, documentation, oversight, evidence and limits.", "canonical_url": "https://regforge.ai/resources/library/evaluate-ai-governance-software", "agent_url": "https://regforge.ai/agent/resources/library/evaluate-ai-governance-software", "markdown_url": "https://regforge.ai/agent/resources/library/evaluate-ai-governance-software.md", "published": "2026-10-15", "updated": "2026-10-15" } ] }