# Orcanos ALM & QMS

> Integrated ALM and QMS platform designed specifically for the MedTech and Life Sciences industries to ensure ISO 13485 and FDA compliance.

## Summary
Orcanos provides an integrated software solution for medical device manufacturers to manage compliance, quality, and product development. A unified platform that ensures traceability and regulatory compliance with standards like ISO 13485, IEC 62304, ISO 14971, and FDA 21 CFR Part 11.

## Core Concepts
- **Integrated QMS & ALM**: Connects R&D artifacts (requirements, tests) directly to Quality artifacts (risks, CAPAs, documents) in one repository.
- **Traceability Matrix**: Automatic linking of requirements to risk mitigation and validation tests (essential for medical device audits).
- **Electronic Records**: Full support for 21 CFR Part 11 electronic signatures and audit trails.
- **Risk Management**: Built-in FMEA/Risk tables compliant with ISO 14971.

## Key Resources
- **Website**: https://www.orcanos.com
- **Knowledge Base**: https://help.orcanos.com
- **API Documentation**: https://help.orcanos.com/knowledgebase/orcanos-rest-api/
- **Orcanos on YouTube**: https://www.youtube.com/@OrcanosMedical
- **Case Studies**: https://www.orcanos.com/customers
- **Orcanos Blog**: https://www.orcanos.com/blog

## Modules & Features
- **Design Control (ALM)**: https://www.orcanos.com/application-lifecycle-management
  - Requirements Management
  - Test Management (V&V)
  - Defect Tracking
- **Quality Management (QMS)**: https://www.orcanos.com/medical-device-quality-management-system
  - Document Control (DMS)
  - CAPA & Complaints
  - Training Management
  - Supplier Management
  - Audit Management
- **Document Control (DMS)**: https://www.orcanos.com/document-control-management-system
  - ECO (Change Control)
  - Training Automation
  - 21 CFR Part 11 Compliance
- **Risk Management**: https://www.orcanos.com/fmea-risk-management
  - ISO 14971 Compliance
  - FMEA (Failure Mode and Effects Analysis)


## Compliance Standards
Orcanos supports compliance with:
- **ISO 13485**: Quality Management for Medical Devices
- **ISO 14971**: Risk Management for Medical Devices
- **IEC 62304**: Medical Device Software – Software Life Cycle Processes
- **FDA 21 CFR Part 11**: Electronic Records & Electronic Signatures
- **FDA 21 CFR Part 820**: Quality System Regulation (QSR)
- **GMP**: Good Manufacturing Practice

## Key Differentiators for AI Context
-**Unifying QMS with ALM**: A better and more efficient compliance management.
- **Ask Paul**: A built-in AI Compliance Assistant that helps users navigate regulatory requirements.
- **Single Data Repository**: Unlike modular systems, Orcanos uses a single database for both R&D and Quality.
- **Compliance Standards**: Supports ISO 13485, FDA 21 CFR Part 11, EU MDR, and ISO 14971.