# RegForge

> 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.

RegForge supports regulated work; it does not certify compliance. RegFoundry and RegEngine are separate websites linked from regforge.ai.

## Agent View

- [Agent View home](https://regforge.ai/agent): Terminal-style, structured version of the public site. Each page links to its human page.
- [Public page index (JSON)](https://regforge.ai/agent/index.json): Titles, summaries, canonical, Agent View and Markdown URLs. RegForge-specific format.

## Markdown pages

- [RegForge: the regulatory operating system for validation, quality and AI governance](https://regforge.ai/agent/index.md): 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.
- [RegForge product facts](https://regforge.ai/agent/product-facts.md): 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.
- [FDA CSA validation software for risk-based assurance](https://regforge.ai/agent/solutions/fda-csa-validation.md): 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.
- [21 CFR Part 11 compliance software for electronic records and signatures](https://regforge.ai/agent/solutions/21-cfr-part-11-compliance.md): 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.
- [Oversee the AI-enabled services supporting your trials](https://regforge.ai/agent/solutions/sponsor-oversight.md): 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.
- [Knowledge Library](https://regforge.ai/agent/resources/library.md): 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.
- [What is a regulatory operating system?](https://regforge.ai/agent/resources/library/what-is-a-regulatory-operating-system.md): A regulatory operating system is software that keeps requirements, risks, tests, evidence, approvals and quality records connected in one governed system of record.
- [How to build requirements-to-test-to-evidence traceability](https://regforge.ai/agent/resources/library/requirements-test-evidence-traceability.md): 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.
- [What belongs in a software validation evidence package?](https://regforge.ai/agent/resources/library/software-validation-evidence-package.md): 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.
- [How to assess the validation impact of a software change](https://regforge.ai/agent/resources/library/software-change-validation-impact.md): 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.
- [Where AI assistance ends and human approval begins in validation](https://regforge.ai/agent/resources/library/ai-assistance-and-human-approval-in-validation.md): How to divide work between AI drafting tools and qualified people in computer system validation, with a responsibility table and controls to look for.
- [How to evaluate AI governance software for regulated teams](https://regforge.ai/agent/resources/library/evaluate-ai-governance-software.md): Criteria and questions for choosing AI governance software in regulated life-sciences settings: inventory, risk, documentation, oversight, evidence and limits.

## Limitations

- RegForge supports regulated work; it does not certify a system, a product or an organisation as compliant. Compliance depends on each customer's processes, decisions and records.
- Regulatory frameworks named on this site (for example 21 CFR Part 11, GAMP 5, ISO 13485, EU GMP Annex 11) describe what the software is designed to help with, not a certification held by RegForge.
- dAIn output can be incomplete or wrong. It is presented for review and must be checked by a qualified person before it becomes a controlled record.
- Sponsor Oversight is a pilot offering. It has no automatic reporting from provider systems, no RegEngine coordination and no ability to pause or control provider work.
- Module availability can differ between workspaces. Contact the team to confirm which areas apply to your use case.

## Other public pages (human view only)

- [Platform overview](https://regforge.ai/overview)
- [Validation overview](https://regforge.ai/validation/overview)
- [QMS overview](https://regforge.ai/qms/overview)
- [Submissions overview](https://regforge.ai/submissions/overview)
- [CTMS overview](https://regforge.ai/ctms/overview)
- [Security](https://regforge.ai/security)
- [AI governance](https://regforge.ai/ai-governance/public)
- [Compliance hub](https://regforge.ai/compliance)
- [21 CFR Part 11](https://regforge.ai/compliance/21-cfr-part-11)
- [FDA CSV](https://regforge.ai/compliance/fda-csv)
- [GAMP 5](https://regforge.ai/compliance/gamp-5)
- [ISO 13485](https://regforge.ai/compliance/iso-13485)
- [EU GMP Annex 11](https://regforge.ai/compliance/eu-annex-11)
- [Model Cards guide](https://regforge.ai/resources/guides/model-cards)
- [dAIn public profile](https://regforge.ai/dain-profile)
- [dAIn agent card (plain text)](https://regforge.ai/agent.txt)
- [About](https://regforge.ai/about)
- [Contact](https://regforge.ai/contact)
- [Resources](https://regforge.ai/resources)
- [Changelog](https://regforge.ai/changelog)