Compliance Frameworks

Supernal Coding supports multiple compliance frameworks, providing comprehensive templates, validation rules, and implementation guidance for each. This document provides an overview of supported frameworks and their integration capabilities.

Supported Frameworks

🏥 ISO 13485 Medical Device Quality Management

Industry: Medical Device Manufacturing
Scope: Quality management systems for medical devices
Key Focus: Design controls, risk management, regulatory compliance

• Requirements Coverage: 14 core requirement templates
• Validation: Automated design control validation
• Evidence Generation: Clinical evaluation documentation
• Audit Support: FDA and notified body preparation

View ISO 13485 Framework →

🇺🇸 FDA 21 CFR Part 11 Electronic Records

Industry: Life Sciences, Pharmaceuticals
Scope: Electronic records and electronic signatures
Key Focus: Data integrity, audit trails, system validation

• Requirements Coverage: 14 electronic records requirements
• Validation: Computer system validation (CSV) processes
• Evidence Generation: Audit trail documentation
• Compliance Tools: Electronic signature validation

View FDA 21 CFR Part 11 Framework →

🇪🇺 GDPR Data Protection

Industry: Any organization processing EU personal data
Scope: Personal data protection and privacy
Key Focus: Data subject rights, privacy by design, consent management

• Requirements Coverage: 17 data protection requirements
• Validation: Privacy impact assessments (DPIA)
• Evidence Generation: Data processing records
• Rights Management: Automated data subject request handling

View GDPR Framework →

🔒 SOC 2 Security Controls

Industry: Technology service providers
Scope: Security, availability, processing integrity, confidentiality
Key Focus: Trust service criteria, security controls

• Requirements Coverage: 18 security control requirements
• Validation: Control effectiveness testing
• Evidence Generation: Security monitoring reports
• Audit Preparation: Type I and Type II readiness

View SOC 2 Framework →

Framework Comparison

Framework	Industry Focus	Primary Concern	Audit Frequency	Complexity
ISO 13485	Medical Devices	Product Safety	Annual	High
FDA 21 CFR Part 11	Life Sciences	Data Integrity	Inspection-based	Medium
GDPR	All Industries	Privacy Rights	Ongoing	Medium
SOC 2	Technology	Security Controls	Annual/Bi-annual	High

Multi-Framework Integration

Framework Overlap Analysis

Many organizations need to comply with multiple frameworks simultaneously. Supernal Coding provides intelligent overlap detection and unified compliance management:

// Example: Medical device company with multiple compliance needs
const complianceConfig = {
  primaryFrameworks: ['iso13485', 'fda21cfr11'],
  secondaryFrameworks: ['gdpr', 'soc2'],
  overlapOptimization: true,
  unifiedReporting: true,
};

// Automatic requirement mapping
const mappedRequirements =
  await complianceEngine.mapRequirements(complianceConfig);

// Unified compliance score
const overallScore =
  await complianceEngine.calculateUnifiedScore(mappedRequirements);

Common Control Areas

Several control areas are common across frameworks:

Access Control

• ISO 13485: User access to quality system
• FDA 21 CFR Part 11: System access controls
• GDPR: Access to personal data
• SOC 2: Logical access controls

Audit Trails

• ISO 13485: Quality system records
• FDA 21 CFR Part 11: Electronic record audit trails
• GDPR: Data processing logs
• SOC 2: System activity monitoring

Change Management

• ISO 13485: Design change controls
• FDA 21 CFR Part 11: System change controls
• GDPR: Privacy impact of changes
• SOC 2: Change management procedures

Implementation Strategies

Phased Implementation

graph LR
    A[Assessment] --> B[Planning]
    B --> C[Foundation]
    C --> D[Core Controls]
    D --> E[Advanced Features]
    E --> F[Optimization]

    subgraph "Phase 1: Foundation"
        C1[Document Management]
        C2[User Access]
        C3[Basic Audit Trails]
    end

    subgraph "Phase 2: Core Controls"
        D1[Risk Management]
        D2[Change Control]
        D3[Validation Processes]
    end

    subgraph "Phase 3: Advanced"
        E1[Automated Monitoring]
        E2[Real-time Dashboards]
        E3[Predictive Analytics]
    end

Framework Selection Criteria

Business Requirements

• Industry: What industry are you in?
• Geography: Where do you operate?
• Data Types: What types of data do you process?
• Customer Requirements: What do your customers require?

Technical Considerations

• System Architecture: Cloud, on-premise, hybrid?
• Data Volume: How much data do you process?
• Integration Needs: What systems need to integrate?
• Automation Level: How much automation do you want?

Resource Assessment

• Team Size: How many people will manage compliance?
• Budget: What's your compliance budget?
• Timeline: When do you need to be compliant?
• Expertise: What compliance expertise do you have?

Getting Started

Quick Start Guide

1. Assessment: Determine which frameworks apply to your organization
2. Prioritization: Rank frameworks by business criticality
3. Planning: Create implementation roadmap
4. Foundation: Set up core compliance infrastructure
5. Implementation: Deploy framework-specific controls
6. Validation: Test and validate compliance controls
7. Monitoring: Establish ongoing compliance monitoring

Framework-Specific Quick Starts

• ISO 13485 Quick Start
• FDA 21 CFR Part 11 Quick Start
• GDPR Quick Start
• SOC 2 Quick Start

Compliance Processes

Supernal Coding provides standardized processes that work across all frameworks:

Implementation Processes

Technical implementation guides for compliance controls:

• Security controls implementation
• Electronic signatures and audit trails
• Change management processes
• Data protection measures

Assessment Processes

Methodologies for evaluating compliance posture:

• Privacy impact assessments
• Risk assessments
• Gap analysis procedures
• Vendor assessments

Audit Processes

Preparation and management of compliance audits:

• Audit preparation checklists
• Evidence collection procedures
• Audit response management
• Continuous monitoring

Validation Processes

Validation and verification procedures:

• Computer system validation
• Process validation
• Testing protocols
• Verification procedures

Advanced Features

AI-Powered Compliance

• Requirement Generation: AI-assisted requirement creation
• Gap Analysis: Automated compliance gap detection
• Risk Assessment: AI-powered risk analysis
• Evidence Collection: Automated evidence gathering

Real-Time Monitoring

• Compliance Dashboards: Live compliance status monitoring
• Alert Systems: Real-time compliance alerts
• Trend Analysis: Compliance trend identification
• Predictive Analytics: Proactive compliance management

Integration Capabilities

• API Integration: RESTful API for system integration
• Webhook Support: Real-time event notifications
• CLI Tools: Command-line compliance management
• CI/CD Integration: Automated compliance validation

Support and Resources

Documentation

• Framework-specific implementation guides
• API documentation and examples
• Best practices and case studies
• Troubleshooting guides

Community

• User forums and discussions
• Framework-specific user groups
• Regular webinars and training
• Compliance expert network

Professional Services

• Implementation consulting
• Custom framework development
• Training and certification
• Ongoing support and maintenance

Related Documentation

• Compliance Overview - Introduction to compliance management
• Compliance Visualization - Visual compliance mapping
• Implementation Guides - Technical implementation
• API Reference - Integration documentation

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Supernal Coding's multi-framework approach enables organizations to efficiently manage compliance across multiple regulatory requirements while minimizing overhead and maximizing control effectiveness.