Implementation Timeline
From planning to go-live: your journey to digital GxP documentation
Typical Implementation Schedule
Most organisations are fully operational within 4-8 weeks
Step-by-Step Process
Each phase is designed to ensure successful adoption with minimal disruption
Discovery & Planning
Understanding your current documentation processes and planning the transition
System Configuration
Setting up Docufen to work with your existing documents and workflows
Document Migration
Transferring your Word documents to the Docufen platform
User Training
Training your team on the digital document completion process
Testing & Validation
Comprehensive testing and validation of the system with your documents
Go-Live & Support
Going live with full support and ongoing assistance
Validation Made Simple
Leverage our comprehensive validation package to demonstrate system compliance with all regulatory requirements.
| # | Doc ID | Document |
|---|---|---|
| 1 | VP-001 | Validation Plan |
| 2 | RS-001 | Requirement Specification |
| 3 | PRA-001 | Process Risk Assessment & Critical Thinking |
| 4 | FRA-001 | Functional Risk Assessment |
| 5 | CS-001 | Configuration Specification |
| 6 | IQ-001 | Installation Qualification Protocol |
| 7 | IQR-001 | Installation Qualification Report |
| 8 | OQ-001 | Operation Qualification Protocol (CSV) |
| 9 | OQR-001 | Operation Qualification Report (CSV) |
| 10 | RTM-001 | Requirements & Risks Trace Matrix |
| 11 | VR-001 | Validation Report |
Critical Thinking Application
Identifying what truly matters for patient safety, product quality, and data integrity
Risk-Based Approach
Concentrating validation efforts on high-risk functionalities through comprehensive risk assessments
Leveraging Vendor Documentation
Utilising supplier documentation to reduce validation burden
Scalable Validation
Tailoring the extent of validation activities to your organisation's specific risk profile
Continuous Compliance
Establishing a framework for maintaining validated state throughout the system lifecycle
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.
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).
Specialized Services:
- 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.
Minimizing Implementation Risk
Our proven approach reduces risk while ensuring regulatory compliance
Low Risk Implementation
Minimal disruption to existing processes with gradual adoption
Validation Support
Comprehensive validation package and expert guidance available
Scalable Approach
Start small with pilot documents and scale based on success
Risk-Based Validation
Tailoring the extent of validation activities to your organisation's specific risk profile
Keys to Successful Implementation
Technical Requirements
- Microsoft 365 environment with appropriate licenses
- Azure Active Directory for user authentication
- Standard web browsers (Chrome, Edge, Firefox)
- Network connectivity to cloud services
Organizational Readiness
- Executive sponsorship and change management support
- Dedicated project team with clear responsibilities
- User training and support plan
- Validation and compliance strategy