Docufen is a comprehensive web-based document completion system designed specifically for Food & Drug companies to handle all GxP Document categories electronically while maintaining full compliance with 21 CFR Part 11 regulations. This modern platform transforms how pharmaceutical and food manufacturing companies manage batch records, validation protocols, logbooks, and other critical GxP documentation through an intuitive digital workflow that eliminates the need for printing and wet ink signatures.

The system features a sophisticated document lifecycle management approach with distinct phases: Pre-Approval signatures, Execution with real-time data entry, and Post-Approval finalisation. Users can digitally complete forms with smart input tools, attach supporting documentation, add digital signatures with role-based authentication, and track document progress through customisable workflows.

The Value that Docufen Delivers:

1. Complete Digital Workflow Management: Provides end-to-end digital document processing from pre-approval through final approval, with built-in workflow tracking and stage management.
2. Intelligent Document Execution: Features smart data entry tools with pre-defined options, real-time validation, and context-aware input assistance that reduces errors and speeds completion.
3. Role-Based Digital Signatures: Implements secure, compliant digital signing with role verification (Author, Reviewer, Approver) ensuring proper authentication and audit trails.
4. Seamless Integration with Existing QMS/DMS: Connects with your current Quality Management Systems and Document Management Systems, preserving existing workflows while enhancing capabilities.
5. Real-Time Collaboration and Sharing: Enables multiple team members to collaborate on documents simultaneously with secure sharing capabilities and live document status updates.
6. Comprehensive Audit Trail and Compliance: Automatically generates complete audit trails, maintains document versioning, and ensures 21 CFR Part 11 compliance throughout the entire document lifecycle.
7. User-Friendly Interface with Minimal Training: Intuitive web-based interface requires minimal training, with guided workflows that make adoption quick and effective.
8. Flexible Document Type Support: Handles all GxP document categories with customisable templates and workflows, from simple batch records to complex validation protocols.
9. Cloud-Based Accessibility and Scalability: Web-based platform provides secure access from anywhere, with scalable architecture that grows with your organisation's needs.

Docufen is ideal for Food & Drug Manufacturing sites seeking a modern, comprehensive digital solution to transform their GxP documentation processes, ensuring regulatory compliance, eliminating paper-based inefficiencies, and establishing a foundation for digital transformation in quality operations.