RegFoundry Platform

    RegForge — Compliance Automation Platform

    Compliance Automation Platform

    The engineering layer of the RegFoundry platform. RegForge delivers regulatory workflows, validation automation, and inspection readiness — powered by DAIN intelligence.

    Capabilities

    Compliance Engineering, Not Consulting Decks

    RegForge transforms regulatory requirements into executable workflows, automated documentation, and continuous audit readiness.

    SOP Generation

    Automatically generate and maintain standard operating procedures aligned with current regulatory requirements.

    Validation Automation

    Risk-based validation workflows for GxP systems, cloud platforms, and AI-enabled applications.

    Audit Readiness

    Continuous inspection readiness with automated documentation, gap analysis, and remediation tracking.

    Risk Modeling

    Quantitative risk assessment powered by DAIN intelligence across regulatory domains and jurisdictions.

    Regulatory Intelligence Workflows

    Operationalize regulatory changes into actionable tasks, assignments, and compliance updates.

    Document Compliance Analysis

    AI-powered review of submissions, protocols, and regulatory documents against applicable requirements.

    Platform Architecture

    Powered by DAIN Intelligence

    RegForge doesn't operate in isolation. Every workflow, every validation template, every risk model is powered by DAIN's regulatory reasoning engine and grounded in the rEGS knowledge graph.

    DAIN provides the regulatory reasoning
    rEGS stores the regulatory intelligence
    RegForge executes the compliance workflows

    Enterprise Use Cases

    • Automated 21 CFR Part 11 validation workflows
    • AI-generated SOP templates with regulatory citations
    • Continuous audit readiness monitoring
    • Cross-jurisdictional compliance gap analysis
    • Regulatory change impact assessment workflows
    • Inspection preparation and CAPA automation

    Ready to Automate Compliance?

    Talk to our team about implementing RegForge for your organization.

    Contact Our Team