{
  "schema": "complianceworxs.agent-facts/1",
  "updated": "2026-10-18",
  "organization": {
    "name": "ComplianceWorxs",
    "website": "https://www.complianceworxs.com/",
    "positioning": "The Record Behind the Decision",
    "summary": "ComplianceWorxs preserves the reasoning behind one consequential GMP decision as a record an inspector can read: who authorized it, on what evidence, how risk was weighed, and why it was justified. Quality systems preserve what happened; ComplianceWorxs preserves why it was authorized.",
    "audience": "Quality, validation, regulatory affairs and compliance leaders in inspection-governed life-science companies."
  },
  "boundaries": [
    "ComplianceWorxs does not make, approve or recommend GMP decisions. The regulated organization remains responsible for its decisions and evidence.",
    "ComplianceWorxs does not give regulatory, legal or compliance advice, and cannot say whether a record or decision is adequate or compliant.",
    "ComplianceWorxs does not draft or submit a Form FDA 483 response and does not communicate with FDA for a customer.",
    "Do not send confidential records, proprietary decision facts, patient information or sensitive documents to ComplianceWorxs through a software agent."
  ],
  "problem_solved": "The work is complete but the reasoning behind the authorization was never written down, so it is reconstructed after the fact. The inspection risk is undocumented authorization reasoning.",
  "offers": [
    {
      "id": "dda",
      "name": "Decision Documentation Assessment (DDA)",
      "price": "Free",
      "use_when": "The buyer is unsure whether an existing record explains who authorized one completed decision and why.",
      "details": [
        "About 3 minutes",
        "7 questions",
        "No documents, email, account or sales call required",
        "Immediate executive report based only on the answers given"
      ],
      "url": "https://www.complianceworxs.com/decision-defensibility-assessment/",
      "human_required": true
    },
    {
      "id": "sample",
      "name": "Completed sample record",
      "price": "Free",
      "use_when": "The buyer wants to see what a finished record looks like (anonymized example).",
      "url": "https://www.complianceworxs.com/sample/",
      "human_required": false
    },
    {
      "id": "case_files",
      "name": "Case Files",
      "price": "$149 each",
      "use_when": "The buyer wants to see the reasoning behind one decision type, laid out as an inspector reads it (worked examples, not client records).",
      "availability": "CAPA Effectiveness, Deviation Closure, OOS Investigation, Change Control Approval, Process Validation and Batch Release Authorization are delivered after checkout. The other Case Files in the series are being completed and are delivered to the checkout email when ready.",
      "details": [
        "Your $149 applies toward the $497 Inspection Response Record if you later preserve a real decision"
      ],
      "items": [
        {
          "name": "CAPA Effectiveness Case File",
          "decision": "CAPA",
          "url": "https://www.complianceworxs.com/case-files/capa-effectiveness/"
        },
        {
          "name": "Deviation Closure Case File",
          "decision": "Deviation & OOS",
          "url": "https://www.complianceworxs.com/case-files/deviation-closure/"
        },
        {
          "name": "Batch Release Authorization Case File",
          "decision": "Batch Release",
          "url": "https://www.complianceworxs.com/case-files/batch-release-authorization/"
        },
        {
          "name": "Change Control Approval Case File",
          "decision": "Change Control & Validation",
          "url": "https://www.complianceworxs.com/case-files/change-control-approval/"
        },
        {
          "name": "Process Validation Case File",
          "decision": "Process validation",
          "url": "https://www.complianceworxs.com/case-files/process-validation/"
        },
        {
          "name": "OOS Investigation Case File",
          "decision": "OOS investigation",
          "url": "https://www.complianceworxs.com/case-files/oos-investigation/"
        }
      ],
      "url": "https://www.complianceworxs.com/case-files/",
      "human_required": true
    },
    {
      "id": "case_file_bundle",
      "name": "Case File bundle: any three",
      "price": "$275 for any three of the five paid Case Files ($447 bought separately)",
      "use_when": "The buyer wants to see the reasoning behind more than one decision type. The buyer chooses the three on the offer page; Batch Release Authorization is free and not part of the bundle.",
      "details": [
        "Each chosen Case File is delivered as its own private-access email to the checkout address",
        "No subscription"
      ],
      "url": "https://www.complianceworxs.com/case-files/choose-three/",
      "human_required": true
    },
    {
      "id": "case_file_series",
      "name": "Complete Case File Series",
      "price": "$875 for the set of ten Case Files",
      "status": "Purchase is paused until all ten Case Files are complete and can be delivered together.",
      "use_when": "A team wants to compare how recurring decisions across Quality, Regulatory, manufacturing, suppliers and CAPA are supported, once the series is available.",
      "url": "https://www.complianceworxs.com/case-files/complete-series/",
      "human_required": true
    },
    {
      "id": "irr",
      "name": "Inspection Response Record (IRR)",
      "price": "$497 per decision",
      "use_when": "Reached through the Case File credit, or directly when one consequential, completed GMP decision needs the record behind it now. One IRR covers one decision.",
      "details": [
        "Not a template and not priced by seat",
        "Anything the existing record cannot support is shown as a finding, never invented",
        "Payment is non-refundable once substantive fulfillment work has begun, except where required by law or where ComplianceWorxs cannot provide the service (Terms of Service, Section 9). A paid record that fails to prepare can be retried without a second charge.",
        "Prepaid coverage during the current bounded bundle test: 5 IRRs $2,360; 10 IRRs $4,475; valid 12 months, no rollover"
      ],
      "url": "https://www.complianceworxs.com/pharma/irr-record/",
      "human_required": true
    },
    {
      "id": "decision_coverage",
      "name": "Decision Coverage (recurring)",
      "price": "Individual $999 per month (3 included records); Team $2,500 per month (8 included records); organization plans by written order form",
      "use_when": "A team has a continuing flow of consequential decisions.",
      "details": [
        "12-month plans, billed monthly, cancel any time, no automatic renewal; 10% off when the full 12 months is paid in advance",
        "Terms: https://www.complianceworxs.com/terms-of-service/ (Section 19)"
      ],
      "url": "https://www.complianceworxs.com/pricing/",
      "human_required": true
    },
    {
      "id": "decision_record",
      "name": "Inspection Response Decision Record",
      "price": "$1,500",
      "use_when": "Only after a completed paid IRR shows earlier reasoning needs to be reconstructed, strengthened and preserved. Not a starting point.",
      "url": "https://www.complianceworxs.com/decision-record/",
      "human_required": true
    }
  ],
  "routing": [
    {
      "if": "Unsure whether the existing record explains who authorized a decision and why",
      "start_with": "dda"
    },
    {
      "if": "Wants to see the reasoning for a decision type first, or is ready to start",
      "start_with": "case_files"
    },
    {
      "if": "One consequential decision needs the record preserved now (the Case File credit applies)",
      "start_with": "irr"
    },
    {
      "if": "Broad or active exposure (Form 483, upcoming inspection)",
      "start_with": "dda"
    }
  ],
  "purchasing": {
    "agents_may": [
      "Read this page and the linked pages",
      "Ask questions at the question endpoint",
      "Shortlist an offer for the buyer"
    ],
    "agents_may_not": [
      "Complete a purchase, enter payment details or accept terms for the buyer"
    ],
    "note": "Checkout, terms acceptance and payment are completed by a person on the offer page."
  },
  "human_contact": {
    "page": "https://www.complianceworxs.com/support/",
    "email": "support@complianceworxs.com",
    "response": "Within one business day"
  },
  "question_endpoint": {
    "url": "https://www.complianceworxs.com/api/agent/ask",
    "method": "POST",
    "body": {
      "question": "string, up to 600 characters",
      "agent": {
        "name": "string, your agent name",
        "on_behalf_of": "string, optional, a description, not a person's name"
      }
    },
    "returns": "answer, refused, next_step (label, absolute url, offer_id), human_next_step, facts_url",
    "limits": "Answers come from the approved facts here. Regulatory, legal and compliance questions are declined and routed to the DDA. About 20 requests per minute per address."
  },
  "other_sources": {
    "llms_txt": "https://www.complianceworxs.com/llms.txt",
    "sitemap": "https://www.complianceworxs.com/sitemap-index.xml",
    "how_it_works": "https://www.complianceworxs.com/how-it-works/"
  }
}