PRAGMA4U® PREDICTIVE AI

Predictive AI for Life Science Processes.

PRAGMA4U® streamlines the creation of your processes by drawing on your company’s history and leveraging your team’s expertise. Artificial intelligence makes suggestions; the operator decides—you remain in control.

SOPs and
Procedures

AI Proposal

Production Data

Activity History

THE HIDDEN COST

Every day, your team fills out the same fields.

Logbook entries, deviations, change control. Much of the data you enter today already exists in your company’s records. Yet every operator starts from scratch and writes in their own way.

This is evident in the long data entry times, inconsistent data across users and departments, and omissions that come to light during the audit.

Your company already has the know-how. PRAGMA4U® makes it available exactly when you need it.

What is PRAGMA4U® Predictive AI?

PRAGMA4U® Predictive AI is the artificial intelligence feature built into the platform that suggests field values when filling out regulated forms.

It analyzes the company’s history, identifies recurring patterns, and suggests the data point that best fits the context. Each suggestion is clearly highlighted and becomes part of the process only after the operator confirms it, within the validated PRAGMA4U® workflows.

HOW IT WORKS

How It Works, Step by Step

01

Start filling out the form

Open the process and enter the initial data into the configured fields, just as you do every day.

02

AI analyzes the context

As you continue to fill out the form, the AI analyzes the company’s history and identifies patterns and cases relevant to the context of the process.

03

Receive the AI's proposal

The suggested value is displayed directly in the field, highlighted and clearly marked as an AI-generated suggestion.

04

It's up to you

You can accept, modify, or replace the suggested value. The AI assists with the data-entry process without replacing the user’s verification.

05

Saved in the validated workflow

The confirmed data becomes part of the validated PRAGMA4U® workflow of PRAGMA4U®, and the AI suggestion is recorded in the audit trail.

BENEFITS

The Added Value for Regulated Processes

Time Savings

Faster data entry thanks to context-sensitive suggestions, which reduce repetitive tasks.

Data Consistency

Automatic standardization based on company history. A common language across users, shifts, and departments.

QA and Compliance Support

Fewer omissions and greater consistency in processes, to support review, audit, and continuous improvement activities.

TECHNOLOGY

Under the Hood: A Dual-Model Architecture

Under the Hood: A Dual-Model Architecture

PRAGMA4U® programmatically integrates two models with complementary roles into three configurations tailored to your privacy needs.

MAXIMUM SCALABILITY

Cloud​

Rapid provisioning, continuous updates, and highly scalable infrastructure.

MAXIMUM CONTROL

On-premises

LLM and Embedder run on your company’s servers. Data stays within the corporate network, with air-gapped security for the highest privacy requirements.

MAXIMUM SCALABILITY

Cloud​

Rapid provisioning, continuous updates, and highly scalable infrastructure.

MAXIMUM CONTROL

On-premises

LLM and Embedder installed on your company's servers. Data remains confined within the corporate network, with air-gapped security to meet the highest privacy requirements.

GXP COMPLIANCE

AI Designed for GxP Processes

Every architectural decision is designed to ensure that artificial intelligence remains verifiable and manageable over time, in accordance with the “human-in-the-loop” approach outlined in the European guidelines for the use of AI in pharmaceutical manufacturing.
The PRAGMA4U team also supports your company with validation, drawing on over twenty years of experience in the life sciences.
FOR WHOM

A benefit for Every Role

Silent Assistant

PRAGMA4U®’s AI works alongside the operator by following four clear rules

FAQ

Frequently Asked Questions About Predictive AI

No. Data is always saved by the operator. The AI-generated value remains a suggestion, highlighted with a green border, until the operator confirms it. Only then is the database updated through PRAGMA4U®’s validated workflows.

It depends on the configuration you choose. With an on-premises deployment, the LLM and Embedder reside on company servers within an isolated network. Cloud and hybrid configurations offer greater scalability and computing power, with the privacy level defined in consultation with you.

Separate setup and runtime environments, full traceability of every AI suggestion in the audit trail, and data persistence within validated workflows support the entire validation lifecycle. The S4BT team supports you at every stage.

Yes. The AI can be enabled, disabled, or bypassed at any time, while the primary process continues as usual.

From your company’s process history. Semantic search identifies the cases most similar to the one you’re completing, and the language model generates a suggestion based on that context. The richer and more established your process history, the more relevant the suggestions can become.

Bring your company's expertise to every form you fill out.

Discover predictive AI applied to real-world processes. In a dedicated demo, we’ll show you how it works, how to set it up, and how it fits into your validated workflows.