Regulatory Compliance Assured: Docufen is designed to meet the requirements of 21 CFR Part 11, ensuring the way  your documentation is completed, is done with compliant data entries and is audit-ready.

• Validation Plan (VP): Outlines the strategy and steps for validating Docufen and its integration with your systems (QMS, VMS…).
• Requirements Specification (RS): Consolidates user, functional, and design requirements into one comprehensive document.
• Configuration Specification (CS): Describes how the system settings and operational parameters are configured to meet the specified requirements.
• Computer Systems Validation (CSV) Protocol: Ensures Docufen performs as intended in line with regulatory requirements.
• Requirements Trace Matrix (RTM): Maps requirements to validation tests to ensure all aspects are covered and compliant.

Docufen, categorised under GAMP 5 Category 3 as a Commercial Off-The-Shelf (COTS) product, is an application based on universal Good Documentation Practices with non-configurable document completion entries.

Docufen is a Microsoft 365 Certified Application. This certification demonstrates our commitment to the highest standards of security, compliance, and data protection. Docufen ensures your GxP documentation processes are not only pharmaceutically compliant, but also secure and reliable.