Compliance Framework Overview
This document provides an overview of compliance frameworks supported by Supernal Coding. For detailed information, visit the specific framework documentation.
AI-Powered Compliance Architecture
Supported Compliance Frameworks
Supernal Coding provides comprehensive template requirements for the following compliance frameworks:
🏥 ISO 13485 Medical Device Compliance
Medical device quality management system requirements with design controls, risk management, and regulatory compliance.
Key Features:
- Quality Management System templates
- Design Controls (Clause 7.3) requirements
- Risk Management (ISO 14971) integration
- Post-market surveillance procedures
🇺🇸 FDA 21 CFR Part 11 Electronic Records
Electronic records and electronic signatures compliance for FDA-regulated industries.
Key Features:
- Computer System Validation (CSV) procedures
- Electronic signature implementation
- Audit trail requirements
- IQ/OQ/PQ qualification processes
🇪🇺 GDPR Data Protection Compliance
Comprehensive data protection requirements for processing EU residents' personal data.
Key Features:
- Data processing principles implementation
- Data subject rights management
- Privacy by design and by default
- Data breach notification procedures
🔒 SOC 2 Security Controls
Service organization security, availability, and processing integrity controls.
Key Features:
- Security trust service criteria
- Availability and reliability controls
- Processing integrity requirements
- Confidentiality and privacy measures
Getting Started
Quick Start
# Initialize project with specific framework
sc init --framework=iso13485
sc init --framework=fda21cfr11
sc init --framework=gdpr
sc init --framework=soc2
# Initialize with multiple frameworks
sc init --framework=iso13485,gdpr,soc2
Framework Selection Guide
| Framework | Best For | Key Benefits |
|---|---|---|
| ISO 13485 | Medical device software | FDA recognition, global market access |
| FDA 21 CFR Part 11 | Electronic records systems | FDA compliance, validation framework |
| GDPR | EU data processing | Privacy compliance, global data protection |
| SOC 2 | Service organizations | Customer trust, security assurance |
Related Documentation
- Requirement Template Format - Standard requirement structure
- CLI Commands - Available sc commands for compliance
- Validation Guide - Compliance validation processes
This framework overview provides the foundation for implementing compliant software development with Supernal Coding's AI-powered requirement generation and validation system.