Docufen is a regulated document completion system that integrates with Microsoft Word to enable the electronic filling of GxP documents while ensuring compliance with 21 CFR Part 11 and ALCOA++ principles. This solution eliminates the need for printing and manual handling, reducing documentation errors and enhancing data integrity through a secure digital audit trail.
Funding
$130K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
In regulated industries, completing GxP documents often involves printing, manual filling, and scanning, leading to potential errors, data integrity issues, and inefficiencies in maintaining compliance with regulations like 21 CFR Part 11 and ALCOA++ principles. This manual process is time-consuming and increases the risk of non-compliance.
Solution
Docufen is a regulated document completion system (RDCS) that integrates directly with Microsoft Word, enabling users to complete GxP documents electronically while adhering to 21 CFR Part 11 and ALCOA++ guidelines. The system eliminates the need for printing and manual handling by providing a digital environment for completing documents with compliant data entries, such as digital signatures, text, and attachments. Docufen enhances data integrity through a secure digital audit trail and fingerprinting technology that verifies document authenticity. By integrating with existing Document Management Systems (DMS), Quality Management Systems (QMS), Manufacturing Execution Systems (MES), and Validation Management Systems (VMS), Docufen streamlines workflows and reduces the risk of documentation errors.
Target Audience
Docufen is designed for professionals in regulated industries, such as pharmaceuticals, biotechnology, and medical devices, who are responsible for creating, reviewing, and completing GxP documents.
Features
- Microsoft Word add-in for completing GxP documents electronically
- Compliant with 21 CFR Part 11 and ALCOA++ principles
- Secure digital signatures and audit trail
- Fingerprinting technology to verify document authenticity
- Integration with existing DMS, QMS, MES, and VMS systems
- Prevents common documentation errors through built-in Quality by Design
- Paper-like digital completion process