Software for
digitization
and the automation
of your processes
PRAGMA4U® is the All-in-One platform for workflow management, quality control, documentation, training, and data reporting.
Designed for companies in the Pharma & Life Sciences, it adapts to your workflows and departments in a gradual and scalable manner, ensuring full compliance with FDA 21 CFR Part 11, EU Annex 11, and cGMP.
Installation and adoption guaranteed and certified by the PRAGMA4U Method®
Your company's experience at the service of every process
PRAGMA4U®’s predictive AI leverages historical data and corporate know-how to anticipate process workflows, while always leaving control in the operator’s hands.
Manual processes and disconnected systems They have a hidden cost very high.
Manual processes, information scattered across paper, Excel, and email, duplicate tasks, and difficulties in managing internal audits slow down work and increase the risk of errors and noncompliance.
A recent study estimated that the least efficient companies
lose up to 2 million euros for every 50 in revenue!
Sole24ore: “Lean and Operational Excellence: In Search of Lost Productivity”
What are the Benefits of digitization?
Reducing Human Errors
Efficiency and
Speed
Real-Time Visibility
Time and Cost Savings
Reducing Human Errors
Automation and the digitization of workflows drastically reduce the likelihood of manual errors.
Efficiency and Speed
Companies using the platform have seen a significant increase in the number of documents issued and a reduction in the time required to close out processes (e.g., from 10.5 days to 2 days to close out nonconformities).
Real-Time Visibility
Advanced dashboards provide management with real-time monitoring of operational performance, helping to identify bottlenecks.
What can you digitize and manage withPRAGMA4U®
Document Management
Digitize SOPs, forms, and regulatory documentation using:
- controlled versioning
- approval workflows
- electronic signatures
- Complete audit trails
Quality Management System
Manage in a single system:
- CAPA
- deviations
- change control
- nonconformity
- internal audits
- access management
Training and LMS
A GMP Learning Management System for:
- create and manage the entire training process
- Identify skills and qualifications
- Always be prepared for audits and inspections
Integrated regulatory compliance, FDA and Eudralex compliance
PRAGMA4U® is designed to ensure full compliance with FDA 21 CFR Part 11, EU Annex 11, and cGMP, guaranteeing data integrity, complete traceability, and documentation ready for audits and inspections.
Every action is recorded in an audit trail that cannot be modified and has been validated.
With The Platform and the PRAGMA4U® Method , you can gradually digitize your processes, reduce waste, and improve compliance.
This approach can also be applied to processes not included
in our Standard Solutions.
PRAGMA4U® is used in more than 20 countries
“PRAGMA4U® adapts to our system, not the other way around”
Lorenzo Pedrazzini – Deputy General Manager, Gammatom SRL
One history that goes way back
Further Information on the Digital Transformation
From document management to data traceability, explore our articles to improve your processes.
A single platform.
A single partner.
A Structured Approach
- Clear Errors
- Save Time
- Achieve Superior Performance
PRAGMA4U® combines consulting, technology, and operational supportto guide companies through their digital transformation, from process design to their implementation over time.
Request a demo and Discover thePRAGMA4U® Method