🐳 Docker Ecosystem Dashboard
Understanding Docker Build, Compose, Hub, Containers, Images & Kubernetes
CSV/CSA Validation Perspective for GxP Environments
Docker Build
Creates Docker images from Dockerfile instructions. The foundation of containerization.
- Reads Dockerfile
- Creates layered images
- Caching for efficiency
- Multi-stage builds
Docker Compose
Orchestrates multi-container applications using YAML configuration files.
- Define services in YAML
- Manage dependencies
- Network configuration
- Volume management
Docker Hub
Cloud-based registry for storing and distributing Docker images globally.
- Public/Private repos
- Automated builds
- Image versioning
- Community images
Containers
Running instances of Docker images. Isolated, lightweight execution environments.
- Process isolation
- Runtime environment
- Resource limits
- Stateful execution
Images
Read-only templates containing application code, libraries, and dependencies.
- Layered filesystem
- Immutable templates
- Version control (tags)
- Shareable artifacts
Kubernetes
Container orchestration platform for automating deployment, scaling, and management.
- Auto-scaling
- Load balancing
- Self-healing
- Rolling updates
🔄 Docker Workflow & Relationships
⚖️ Docker vs Kubernetes Comparison
| Aspect | Docker | Kubernetes |
|---|---|---|
| Purpose | Containerization platform | Container orchestration system |
| Scope | Single host management | Multi-host cluster management |
| Complexity | Simple, easy to learn | Complex, steeper learning curve |
| Scaling | Manual or Docker Swarm | Automatic horizontal scaling |
| Use Case | Development, small deployments | Production, large-scale systems |
| Load Balancing | Basic (Docker Swarm) | Advanced, built-in |
| Self-Healing | Limited | Automatic restart & replacement |
| Relationship | Creates and runs containers | Orchestrates Docker containers |
✅ CSV/CSA Validation Framework for Containerized Systems
| Validation Phase | Docker/Container Activities | GxP Requirements | Key Documentation |
|---|---|---|---|
| URS (User Requirements) | Define system functionality, performance, security needs | 21 CFR Part 11, GAMP 5 Category 4/5 | URS, System Architecture |
| Risk Assessment | Identify critical vs non-critical containers/services | ISO 14971, ICH Q9, GAMP 5 | Risk Assessment Matrix, FMEA |
| FRS/Design Spec | Document Docker architecture, K8s config, network topology | ALCOA+ principles, Traceability | FRS, System Design, Network Diagrams |
| IQ (Installation) | Verify Docker Engine, K8s cluster, registry setup | Infrastructure qualification | IQ Protocol, Installation Records |
| OQ (Operational) | Test container deployment, scaling, failover, backups | Functional testing, worst-case scenarios | OQ Protocol, Test Scripts, Results |
| PQ (Performance) | Validate in production-like environment with real data | End-to-end workflow validation | PQ Protocol, User Acceptance Test |
| Change Control | Image versioning, container updates, K8s config changes | Impact assessment, revalidation triggers | Change Request, Impact Assessment |
| Audit Trail | Container logs, K8s events, Docker Hub pull history | 21 CFR Part 11 (e-signature, audit trail) | Log Management System, SIEM |
| Data Integrity | Immutable images, version control, access controls | ALCOA+ (Attributable, Legible, Contemporaneous…) | Data Integrity Plan, Access Matrix |
| Disaster Recovery | Image backups, persistent volume backups, cluster recovery | Business continuity, RTO/RPO | DR Plan, Backup Procedures, BCP |
| Periodic Review | Annual validation status check, security patches | Ongoing compliance, revalidation needs | Periodic Review Report, Validation Summary |
🔐 Key Validation Considerations for Docker/K8s in GxP
🎯 Image Management
- ✓ Immutable image tags (avoid “latest”)
- ✓ Private registry with access controls
- ✓ Image scanning for vulnerabilities
- ✓ SHA256 checksums for integrity
- ✓ Version control (semantic versioning)
📋 Configuration as Code
- ✓ Dockerfiles in version control (Git)
- ✓ K8s manifests versioned
- ✓ Infrastructure as Code (IaC)
- ✓ Change control integration
- ✓ Peer review for changes
🔒 Security & Access
- ✓ RBAC (Role-Based Access Control)
- ✓ Network policies & segmentation
- ✓ Secrets management (Vault, K8s secrets)
- ✓ Container runtime security
- ✓ Vulnerability scanning
📊 Monitoring & Logging
- ✓ Centralized logging (ELK, Splunk)
- ✓ Audit trail retention (21 CFR Part 11)
- ✓ Real-time monitoring (Prometheus)
- ✓ Alerting for critical events
- ✓ Performance metrics tracking
🔄 Change Management
- ✓ Rolling updates with validation
- ✓ Rollback procedures documented
- ✓ Blue-green deployments
- ✓ Canary releases for testing
- ✓ Impact assessment before changes
✅ Compliance & Documentation
- ✓ Validation Master Plan (VMP)
- ✓ System lifecycle documentation
- ✓ SOPs for container management
- ✓ Training records for operators
- ✓ Vendor assessment (Docker Inc.)
⚠️ Critical Success Factors for GxP Container Validation
1. Risk-Based Approach (GAMP 5 / ICH Q9)
Classify containers based on criticality. Not all containers need the same validation rigor. Front-end containers may be Category 3, while calculation engines are Category 5.
2. Immutable Infrastructure
Images should be immutable and never modified post-deployment. Changes require new image versions with full traceability.
3. Infrastructure Qualification
Docker Engine, Kubernetes cluster, and underlying infrastructure must be qualified as part of IQ. Document hardware specs, network architecture, and OS configurations.
4. Supplier Assessment
Docker Inc., cloud providers (AWS, Azure, GCP), and any third-party image sources must undergo supplier qualification per GAMP 5 Appendix M7.