HelixOps Validation
DS DS-HELIX-001

Design Specification

HelixOps Quality Management System - GxP Validation Documentation

Version: Draft v0.1
Effective: January 2025
Status: Draft
Author
HelixOps Team
Reviewer
Architecture Lead
Approver
Quality Assurance

1. Introduction #

This Design Specification (DS) defines the technical architecture and implementation details for the HelixOps platform. It translates the functional specifications from FS-HELIX-001 into concrete technical designs.

Technical Scope

This document covers system architecture, database design, API specifications, security implementation, and deployment configuration.

2. System Architecture #

Three-Tier Architecture

Presentation
React 18 SPA
TanStack Query
Tailwind CSS
Application
Node.js / Express
TypeScript
Drizzle ORM
Data
PostgreSQL 15
Redis Cache
S3 Storage

Technology Stack

Layer Technology Version Purpose
Frontend React 18.3.x UI framework
Frontend TanStack Query 5.x Data fetching & caching
Frontend Tailwind CSS 3.4.x Styling
Backend Node.js 20 LTS Runtime environment
Backend Express 4.x HTTP framework
Backend TypeScript 5.x Type safety
Database PostgreSQL 15.x Primary database
ORM Drizzle 0.29.x Database access

3. Database Design #

The database schema is designed to support all HelixOps modules with proper normalization and referential integrity.

Core Entity Relationship

users 1:N risks
risks N:M controls
controls N:M frameworks

Risk Table Schema

schema/risks.sql sql
CREATE TABLE risks (
  id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
  title VARCHAR(255) NOT NULL,
  description TEXT,
  category VARCHAR(50) NOT NULL,
  status VARCHAR(20) DEFAULT 'Open',
  likelihood INTEGER CHECK (likelihood BETWEEN 1 AND 5),
  impact INTEGER CHECK (impact BETWEEN 1 AND 5),
  risk_score INTEGER GENERATED ALWAYS AS (likelihood * impact) STORED,
  treatment VARCHAR(20),
  owner_id UUID REFERENCES users(id),
  created_at TIMESTAMPTZ DEFAULT NOW(),
  updated_at TIMESTAMPTZ DEFAULT NOW(),
  created_by UUID REFERENCES users(id),
  updated_by UUID REFERENCES users(id)
);

Audit Log Table Schema

schema/audit_logs.sql sql
CREATE TABLE audit_logs (
  id UUID PRIMARY KEY DEFAULT gen_random_uuid(),
  timestamp TIMESTAMPTZ DEFAULT NOW() NOT NULL,
  user_id UUID NOT NULL REFERENCES users(id),
  action VARCHAR(20) NOT NULL,
  entity_type VARCHAR(50) NOT NULL,
  entity_id UUID,
  old_values JSONB,
  new_values JSONB,
  ip_address INET,
  user_agent TEXT,
  session_id VARCHAR(255)
);

-- Immutable audit log (no UPDATE/DELETE triggers)
CREATE INDEX idx_audit_timestamp ON audit_logs(timestamp);
CREATE INDEX idx_audit_user ON audit_logs(user_id);
CREATE INDEX idx_audit_entity ON audit_logs(entity_type, entity_id);

4. API Design #

The API follows RESTful conventions with consistent response formats and error handling.

Request Format
POST /api/risks
Content-Type: application/json
Authorization: Bearer <token>

{
  "title": "Data breach risk",
  "category": "Cybersecurity",
  "likelihood": 3,
  "impact": 5
}
Response Format
{
  "success": true,
  "data": {
    "id": "uuid-here",
    "title": "Data breach risk",
    "risk_score": 15,
    "created_at": "2025-01-22T..."
  }
}

API Endpoints Summary

Method Endpoint Description Auth
GET /api/risks List all risks Viewer+
POST /api/risks Create new risk Manager+
PATCH /api/risks/:id Update risk Manager+
DELETE /api/risks/:id Soft delete risk Admin
GET /api/audit-logs List audit logs Admin

5. Security Design #

Encryption at Rest
  • • AES-256 database encryption
  • • Encrypted backup storage
  • • Key rotation policy
Encryption in Transit
  • • TLS 1.3 required
  • • HSTS enabled
  • • Certificate pinning

Authentication Flow

User HelixOps OIDC Provider JWT Token Session

6. Deployment Architecture #

HelixOps is deployed on Replit with automated scaling and high availability configuration.

Infrastructure Components
3
App Instances
1
Load Balancer
2
DB Replicas
1
Redis Cluster

7. Performance Requirements #

Metric Target Measurement
Page Load Time <2 seconds (P95) Lighthouse CI
API Response Time <500ms (P95) APM monitoring
Database Query Time <100ms (P95) Query profiling
Concurrent Users 100 without degradation Load testing
Uptime 99.5% Synthetic monitoring

Document Approval

Author
Signature
HelixOps Team
Architecture
Architecture Lead
Signature
Tech Architect
Engineering
Quality Assurance
Signature
QA Manager
Quality Management

Electronic signatures are considered equivalent to handwritten signatures in accordance with 21 CFR Part 11 requirements.