@pactosigna/mcp-server 0.1.0

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+ # @pactosigna/mcp-server
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+ MCP (Model Context Protocol) server for [PactoSigna](https://pactosigna.com) — connects Claude Desktop, Cursor, and other AI tools to your quality management system.
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+ ## Setup
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+ ### Claude Desktop / Cursor
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+ Add to your MCP client configuration:
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+ ```json
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+ {
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+ "mcpServers": {
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+ "pactosigna": {
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+ "command": "npx",
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+ "args": ["-y", "@pactosigna/mcp-server"],
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+ "env": {
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+ "PACTOSIGNA_API_KEY": "your-api-key-here"
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+ }
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+ }
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+ }
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+ }
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+ ```
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+
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+ ### Environment Variables
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+
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+ | Variable | Required | Description |
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+ | --------------------- | -------- | ---------------------------------------------------- |
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+ | `PACTOSIGNA_API_KEY` | Yes | Your PactoSigna API key |
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+ | `PACTOSIGNA_BASE_URL` | No | API base URL (default: `https://qms.pactosigna.com`) |
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+
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+ ## Use Cases
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+ ### Management Review Preparation
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+ Ask your AI assistant to pull quality metrics and draft a management review:
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+ > "Get me the quality metrics for the last quarter and create a management review snapshot"
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+ The MCP server returns KPIs for CAPAs, nonconformances, complaints, training compliance, releases, and audits — everything needed for ISO 13485 §5.6 management review inputs.
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+ ### Quality Trend Analysis
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+ Compare metrics across time periods to identify trends:
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+ > "Compare our quality metrics for the last 30 days vs the last year — are we improving?"
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+
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+ ### Audit Preparation
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+ Pull current quality status before internal or external audits:
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+ > "What's our current CAPA closure rate and training compliance? I need to prepare for next week's audit."
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+ ### Document Authoring
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+ Ask your AI assistant about supported document types and generate compliant templates:
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+ > "What document types does PactoSigna support?"
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+ > "What fields does a user_need document need? What sections are required?"
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+ > "Create a new user need UN-042 about electronic signature workflows"
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+ The MCP server has built-in knowledge of all 65+ document types, their frontmatter schemas, valid enum values, and required sections.
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+ ## Available Tools
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+ ### get_quality_metrics
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+ Returns quality KPIs for a PactoSigna organization including CAPAs, nonconformances, complaints, training, releases, and audits.
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+ **Parameters:**
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+ - `organization_id` (required): The PactoSigna organization ID
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+ - `period` (optional): Time period — `30d`, `90d` (default), or `365d`
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+ ### list_document_types
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+ Lists all 65+ document types supported by PactoSigna with labels and scope (QMS or Device).
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+ **Parameters:** None
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+ ### get_document_schema
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+ Returns the complete frontmatter schema for a document type including field types, valid enum values, required/optional status, and required H2 sections.
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+ **Parameters:**
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+ - `document_type` (required): The document type key (e.g., `user_need`, `requirement`, `software_risk`)
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+ ### generate_document_template
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+ Generates a complete markdown document with correct frontmatter structure and required section headings.
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+ **Parameters:**
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+ - `document_type` (required): The document type key
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+ - `id` (required): The document ID (e.g., `UN-042`)
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+ - `title` (required): The document title
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+ ## Getting an API Key
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+ 1. Log in to [PactoSigna](https://qms.pactosigna.com)
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+ 2. Go to Organization Settings > API Keys
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+ 3. Create a new API key
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+ ## License
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+ MIT