Execute GxP Documents
in Microsoft Word

Regulated Document Completion System

What is an RDCS?

An RDCS, GxP Software Category, is a system with built-in Quality by Design principles that prevent common documentation errors. It enables the completion of GxP documents with ALCOA++ and 21 CFR Part 11 compliant data entries such as digital signatures, text and attachments, with data integrity and digital GxP traceability.

What an RDCS is NOT

An RDCS is not a DMS, QMS, MES, or VMS. It does not replace your existing systems but enhances them by enabling the digital completion of the Word documents these systems generate, and sending the completed documents back to them. This eliminates the need to print, hand-fill, and scan Word documents into PDFs.

The Value an RDCS Delivers

The same old thing, just digital. Without the tedious paper admin tasks, you can now focus on high-value activities that improve patients’ lives.

Paper-Like Digital Completion

Replace manual document completion with typed digital entries retaining a familiar paper-like process that complements your existing documents and procedures.

Integrated Compliance

Built-in GDocP and 21 CFR Part 11 compliance with Quality by Design and ALCOA++ principles, provide regulatory assurance and data integrity.

Operational Continuity

Preserve existing workflows by seamlessly integrating with DMS, QMS, MES, and VMS systems, enhancing current processes without disruptive changes.

Cost Efficient Quality

Eliminate costs associated with paper-based documentation, including printing, distribution, page labelling, filing, scanning and storage inefficiencies.

User-Friendly Adoption

Use the familiar Microsoft Word interface to minimise the learning curve and accelerate user adoption, with an intuitive task pane to complete your existing documents.

Enhanced Data Accuracy

Prevent common documentation errors with built-in compliance, ensuring contemporaneous and traceable data entries while maintaining document integrity.

Productivity Gain

Increase productivity by reducing time spent on manual document handling, allowing you to focus on more critical tasks that add value to patients’ lives.

Regulatory Confidence

Show inspectors the same pages, only now digital with legible writing and reduced risks. Locate documents and eliminate audit search time. Show you are in control.

But wait. Can’t Word
Documents be tampered with?

Docufen is an add-in that runs inside Microsoft Word, securing your documents with a compliant 21 CFR Part 11 digital seal and audit trail. With fingerprinting technology, the add-in verifies with absolute confidence that a document has not been modified outside the use of Docufen, which logs all activities, ensuring the authenticity and integrity of your content.

GxP Software that feels like paper

Why print Word documents and complete them with a pen, when you can finish them where you start: in Word

Word Integration

Continue using Microsoft Word for all your existing GxP documents such as Batch Records, Forms, Logbooks, Validation Protocols etc.

Workflow Preservation

Keep existing workflows intact; Docufen replaces printing and manual completion. Compatible with QMS, DMS, and VMS.

Risk Reduction

With built-in Quality by Design and Good Documentation Practices, it eliminates common documentation errors.

Execute GxP Documents in Microsoft Word