# Qualio

**Canonical:** https://apis.io/providers/qualio/  
**Website:** https://qualio.com  
**APIs profiled:** 11

Qualio is an AI-powered quality management system (QMS) and compliance platform built for life sciences companies — medical devices, pharmaceuticals, biotech, software as a medical device (SaMD), cosmetics, cannabis and contract research organizations. It unifies document control, quality events (CAPAs, deviations, non-conformances), training records, design controls, risk and change management, supplier management, audits and compliance intelligence in one audit-ready system. Qualio exposes a RESTful Developer API (OpenAPI 3.1.0, base URL https://api.qualio.com) providing secure, API-key-authenticated programmatic access to documents, events, training, users, suppliers, design controls and compliance data, letting teams automate quality processes and integrate the QMS with the rest of their toolchain.

## Kin Score — 48.6 / 100 (developing)

Scored 2026-08-20 under rubric 0.12.0. Trend: flat (+0.0 from 48.6).

| Facet | Score |
|---|---|
| Discoverability | 81.5 |
| Contract Quality | 56.1 |
| Governance | 30.3 |
| Contract Governance | 30.3 |
| Operational Transparency | 15.8 |
| Developer Ergonomics | 42.3 |
| Commercial Clarity | 47.4 |
| Access Clarity | 47.4 |

Regulatory layer — **Health**: 37.5 (matched via tags).

## Agent readiness — 37.0 (agent-ready)

| Dimension | Value |
|---|---|
| Spec Presence | yes |
| Agentic Access | derived |
| Reversibility Documented | no |
| MCP Server | no |
| Auth Clarity | yes |
| Idempotency | no |
| Error Semantics | verified |
| OpenAPI Examples | partial |
| Rate Limit Signal | no |
| Event Surface Described | no |
| Agent Skills | derived |
| Well Known Catalog | no |
| Consent Identity | no |
| Agent Card | no |
| Dry Run Mode | no |

## Access

Self-serve signup — onboarding: self-serve, pricing: unknown, trial: no (confidence: medium).

## APIs (11)

- **Qualio Audit Trail API** — The Audit Trail API from Qualio — 1 operation(s) for audit trail.
- **Qualio Change Management API** — The Change Management API from Qualio — 2 operation(s) for change management.
- **Qualio Compliance Intelligence API** — The Compliance Intelligence API from Qualio — 11 operation(s) for compliance intelligence.
- **Qualio Design Controls API** — The Design Controls API from Qualio — 8 operation(s) for design controls.
- **Qualio Documents API** — The Documents API from Qualio — 12 operation(s) for documents.
- **Qualio Events API** — The Events API from Qualio — 4 operation(s) for events.
- **Qualio Resource Library API** — The Resource Library API from Qualio — 4 operation(s) for resource library.
- **Qualio Suppliers API** — The Suppliers API from Qualio — 4 operation(s) for suppliers.
- **Qualio Tags API** — The Tags API from Qualio — 1 operation(s) for tags.
- **Qualio Training API** — The Training API from Qualio — 2 operation(s) for training.
- **Qualio User Management API** — The User Management API from Qualio — 7 operation(s) for user management.

## MCP servers (1)

- **Qualio MCP Server**

## Agentic access (1)

- **Qualio Agentic Access** — 132 operations · 34 acting · 10 human-in-the-loop

## Security (3)

- **Qualio Authentication** — apiKey · 1 scheme
- **Qualio Domain Security** — TLSv1.3 · HSTS · DMARC
- **Qualio Trust Center** — ISO 9001, ISO 27001, ISO 27701

## Tags

Company, Quality Management, Life Sciences, Compliance, Document Control, QMS, Regulatory, Medical Devices

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Profiled by [API Evangelist](https://apievangelist.com) and published on [APIs.io](https://apis.io/providers/qualio/). Scores are computed from the provider's own public artifacts under a published rubric.
