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  • GxP Agent Runtime

    kogunlowo123
    A
    license
    Not graded
    quality
    B
    maintenance
    Enables AI agents to discover, risk-assess, request, and track actions on validated BioPharma systems (LIMS, MES, QMS, ELN) without bypassing the validated state, routing each request through GAMP 5 risk classification, ALCOA+ checks, approval workflows, and 21 CFR Part 11 e-signatures. Agents can also retrieve signed, verifiable execution records and audit evidence for the actions they perform.
    Apache 2.0

  • GxP MDM MCP Server

    saram-io
    F
    license
    Not graded
    quality
    C
    maintenance
    Enables AI assistants to query and manage a GxP computerized system inventory as a knowledge graph, including blast-radius impact analysis, regulatory lineage, validation-gap detection, audit-trail-compliant status change approvals, and periodic review generation.
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