21 CFR Part 11 Compliance
Regulatory compliance built in from the ground up to ensure your GxP documentation meets the most rigorous standards.
Key Compliance Features
Docufen is designed from the ground up to meet the requirements of 21 CFR Part 11, ensuring your GxP documentation is completed with fully compliant data entries.
Electronic Signatures
Microsoft authentication and comprehensive user verification
Complete Audit Trails
Capturing all document actions, changes, and signatures
Data Integrity Controls
Ensuring content remains attributable, legible, contemporaneous, original, and accurate
Role-Based Access
Limiting system functionality based on authorised user roles
Documentation Error Elimination
Preventing common mistakes through compulsory reason-for-change and strike-through formatting
Automatic Logs Generation
Including audit logs, attachment tracking, and user (signature) logs
Validation Made Simple
Leverage our comprehensive validation package to demonstrate system compliance with all regulatory requirements.
Vendor Comprehensive Validation Package
Docufen provides a complete validation package with all necessary documentation to demonstrate that the system is fit for purpose and compliant with regulatory requirements.
| # | Doc ID | Document |
|---|---|---|
| 01 | VP-001 | Validation Plan |
| 02 | RS-001 | Requirement Specification |
| 03 | PRA-001 | Process Risk Assessment & Critical Thinking |
| 04 | FRA-001 | Functional Risk Assessment |
| 05 | CS-001 | Configuration Specification |
| 06 | IQ-001 | Installation Qualification Protocol |
| 07 | IQR-001 | Installation Qualification Report |
| 08 | OQ-001 | Operation Qualification Protocol (CSV) |
| 09 | OQR-001 | Operation Qualification Report (CSV) |
| 10 | RTM-001 | Requirements & Risks Trace Matrix |
| 11 | VR-001 | Validation Report |
Validation Strategy Overview
Our validation approach follows a streamlined, risk-based methodology aligned with GAMP 5 Second Edition principles.
- 1
Critical Thinking Application
Identifying what truly matters for patient safety, product quality, and data integrity
- 2
Risk-Based Approach
Concentrating validation efforts on high-risk functionalities through comprehensive risk assessments
- 3
Leveraging Vendor Documentation
Utilising supplier documentation to reduce validation burden
- 4
Scalable Validation
Tailoring the extent of validation activities to your organisation's specific risk profile
- 5
Continuous Compliance
Establishing a framework for maintaining validated state throughout the system lifecycle
GAMP 5 Second Edition Compliant
Docufen is categorised under GAMP 5 Category 3 as a Commercial Off-The-Shelf (COTS) product, significantly reducing your validation burden compared to configurable systems.
Regulatory Framework Alignment
Docufen addresses all key requirements of 21 CFR Part 11 and aligns with EU Annex 11 requirements.
Docufen's compliance features are designed to satisfy requirements under both 21 CFR Part 11 and EU Annex 11, making it ideal for organisations with global operations and ensuring consistent compliance across jurisdictions.
- Azure Cosmos DB security and encryption features
- Azure Blob Storage protections and redundancy
- Microsoft Single Sign-On with multifactor authentication
- End-to-end encryption for data in transit and at rest
Validation Support Network
While Docufen provides comprehensive validation documentation, we understand that implementation may require specialised expertise. We can recommend trusted GxP consulting partners who specialise in Computer System Validation (CSV).
- Integration of Docufen into your validation ecosystem
- Customisation of validation approach to your regulatory requirements
- Development of site-specific documentation (Change Control, Risk Assessment, PQ)
- Implementation of best practices for ongoing compliance management
These independent consultants offer the expertise needed to ensure your Docufen implementation meets your specific regulatory needs while maximising efficiency.