@pactosigna/mcp-server

MCP (Model Context Protocol) server for PactoSigna — connects Claude Desktop, Cursor, and other AI tools to your quality management system.

Setup

Claude Desktop / Cursor

Add to your MCP client configuration:

{
  "mcpServers": {
    "pactosigna": {
      "command": "npx",
      "args": ["-y", "@pactosigna/mcp-server"],
      "env": {
        "PACTOSIGNA_API_KEY": "your-api-key-here"
      }
    }
  }
}

Environment Variables

| Variable | Required | Description | | --------------------- | -------- | ---------------------------------------------------- | | PACTOSIGNA_API_KEY | Yes | Your PactoSigna API key | | PACTOSIGNA_BASE_URL | No | API base URL (default: https://qms.pactosigna.com) |

Use Cases

Management Review Preparation

Ask your AI assistant to pull quality metrics and draft a management review:

"Get me the quality metrics for the last quarter and create a management review snapshot"

The MCP server returns KPIs for CAPAs, nonconformances, complaints, training compliance, releases, and audits — everything needed for ISO 13485 §5.6 management review inputs.

Quality Trend Analysis

Compare metrics across time periods to identify trends:

"Compare our quality metrics for the last 30 days vs the last year — are we improving?"

Audit Preparation

Pull current quality status before internal or external audits:

"What's our current CAPA closure rate and training compliance? I need to prepare for next week's audit."

Document Authoring

Ask your AI assistant about supported document types and generate compliant templates:

"What document types does PactoSigna support?"

"What fields does a user_need document need? What sections are required?"

"Create a new user need UN-042 about electronic signature workflows"

The MCP server has built-in knowledge of all 65+ document types, their frontmatter schemas, valid enum values, and required sections.

Available Tools

get_quality_metrics

Returns quality KPIs for a PactoSigna organization including CAPAs, nonconformances, complaints, training, releases, and audits.

Parameters:

• organization_id (required): The PactoSigna organization ID
• period (optional): Time period — 30d, 90d (default), or 365d

list_document_types

Lists all 65+ document types supported by PactoSigna with labels and scope (QMS or Device).

Parameters: None

get_document_schema

Returns the complete frontmatter schema for a document type including field types, valid enum values, required/optional status, and required H2 sections.

Parameters:

• document_type (required): The document type key (e.g., user_need, requirement, software_risk)

generate_document_template

Generates a complete markdown document with correct frontmatter structure and required section headings.

Parameters:

• document_type (required): The document type key
• id (required): The document ID (e.g., UN-042)
• title (required): The document title

Getting an API Key

1. Log in to PactoSigna
2. Go to Organization Settings > API Keys
3. Create a new API key

License

MIT