Regulated Documentation & Cloud Evidence
Inspection-ready evidence set for VDC demo (AWS serverless)
Approved Records (PDF)
SOPs (8)
| Doc ID | Title | Version | Status | Effective Date | Owner/Role | Link (PDF) |
|---|---|---|---|---|---|---|
| SOP-001 | VDC System Governance and Validation | 1.0 | Approved | Feb-01-2026 | QA Manager | |
| SOP-002 | User Management and Access Control for VDC | 1.0 | Approved | Feb-01-2026 | QA Manager | |
| SOP-003 | Document Lifecycle and Workflow in VDC | 1.0 | Approved | Feb-01-2026 | Validation Lead | |
| SOP-004 | Change Control for VDC | 1.0 | Approved | Feb-01-2026 | QA Manager | |
| SOP-005 | Incident, Deviation, and CAPA Management for VDC | 1.0 | Approved | Feb-01-2026 | IT Manager | |
| SOP-006 | Training and Qualification for VDC | 1.0 | Approved | Feb-01-2026 | IT Manager | |
| SOP-007 | Periodic Review and Audit Trail Review for VDC | 1.0 | Approved | Feb-01-2026 | QA Manager | |
| SOP-008 | Data Retention, Backup and Restore for VDC | 1.0 | Approved | Feb-01-2026 | IT Manager |
Validation Package
| Doc ID | Title | Version | Status | Effective Date | Owner/Role | Link (PDF) |
|---|---|---|---|---|---|---|
| VDC-URS-001 | User Requirements Specification | 1.0 | Approved | Feb-01-2026 | Business Owner | |
| VDC-FS-001 | Functional Specification | 1.0 | Approved | Feb-01-2026 | Technical Lead | |
| VDC-RTM-001 | Requirements Traceability Matrix | 1.0 | Approved | Feb-01-2026 | Validation Lead |
Test Evidence
| Doc ID | Title | Version | Status | Effective Date | Owner/Role | Link (PDF) |
|---|---|---|---|---|---|---|
| VDC-IQ-001 | IQ Results | 1.1 | Approved | Feb-01-2026 | Validation Lead | |
| VDC-OQ-001 | OQ Results | 1.1 | Approved | Feb-01-2026 | Validation Lead | |
| VDC-PQ-001 | PQ Results | 1.1 | Approved | Feb-01-2026 | Validation Lead |
Test Reports
| Doc ID | Title | Version | Status | Effective Date | Owner/Role | Link (PDF) |
|---|---|---|---|---|---|---|
| TR-001 | VDC MFA Enforcement | 1.0 | Approved | Feb-01-2026 | Validation Lead | |
| TR-001 | VDC Document Deletion Prevention | 1.0 | Approved | Feb-01-2026 | Validation Lead | |
| TR-001 | VDC Role-Based Access | 1.1 | Approved | Feb-01-2026 | Validation Lead |
Risk & Governance
| Doc ID | Title | Version | Status | Effective Date | Owner/Role | Link (PDF) |
|---|---|---|---|---|---|---|
| VDC-RISK-001 | Risk Assessment / FMEA | 1.0 | Approved | Feb-01-2026 | Risk Manager | |
| VDC-VMP-001 | Validation Strategy / Plan | 1.0 | Approved | Feb-01-2026 | Validation Lead |
Audit Trail Samples
| Doc ID | Title | Version | Status | Effective Date | Owner/Role | Link (PDF) |
|---|---|---|---|---|---|---|
| VDC-AUDIT-001 | Sample Approval Report / Audit Log Export | 1.0 | Approved | Feb-01-2026 | System Administrator |
Supporting Content (Non-controlled)
Note: The content below is provided for reference and context. These are non-controlled documents and HTML pages.
Regulatory Guidance
Enterprise Case Studies
VDC Demo
Live AWS prototype demonstrating 21 CFR Part 11-style controls on a serverless AWS stack (workflow states, role separation, integrity controls, and auditability).
Access VDC Demo →Validated Document Control (VDC)
Live demo →Live AWS prototype that shows exactly how 21 CFR Part 11-style controls look on a serverless AWS stack (workflow states, role separation, integrity controls, and auditability).
Staying Compliant with the FDA
AuthorityPractical ways to interpret regulations and map them to concrete cloud controls (audit trails, identity, integrity, change control, validation strategy).