PRAGMA4U – All-in-One GxP Platform with Integrated AI

PRAGMA4U – All-in-One GxP Platform with Integrated AI
Product Description

PRAGMA4U – All-in-One GxP Platform with Integrated AI

PRAGMA4U is a flexible, modular, and scalable all-in-one platform that supports companies in managing processes, activities, and documentation in compliance with GxP regulations. 

The platform integrates Artificial Intelligence technology to assist users during data entry and document preparation, reducing both execution time and the risk of errors.

PRAGMA4U is designed to adapt to organizations of any size and enables companies to:

  • Automate, standardize, and track complex activities
  • Centralize process management and corporate know-how
  • Improve operational efficiency
  • Ensure continuous compliance with regulatory requirements

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S4BT | PRAGMA4U

  • Country/Region:
    Italy
  • Founded:
    2005
  • On CPHI since:
    2026
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
Contract Service
IT/Software solution provider
Primary activities
OTC
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Technology
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Categories
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Specifications
  • Details
    • QMS (Quality Management System) : Audit (Internal/External) - CAPA - 
      Change Control - Deviations/ Non-conformities -  Complaints - Supplier Management - Brand/Product/Artwork Management - Analytical Non-conformities/OOS - Archived counter samples​ - Stability samples - Controlled label printing
    • DMS (Document Management System)
    • LMS (Learning Management System)
    • Electronic Batch Record
    • Electronic Logbook 
    • User Access Management / Periodic User Review
    • HSE - Events/ Incidents

    Integrated Document Editor
    PRAGMA4U enables users to create, edit, and manage documents directly within the platform using predefined templates. All changes, reviews, and attachments remain fully traceable and version-controlled within a single regulated environment.

  • Selling Points
    AI 4U: PRAGMira

    PRAGMira brings Artificial Intelligence into GxP-regulated processes through a compliant and controlled approach, featuring defined intended use, governed access, human oversight, and secure data management.

    Integrated within PRAGMA4U, it learns from the platform context and provides relevant, process-driven suggestions that help users complete tasks faster and more accurately. Organizations benefit from greater process consistency, improved data governance, and stronger documentation.
  • Supplied from
    Italy
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Sales Markets
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S4BT | PRAGMA4U

  • Country/Region:
    Italy
  • Founded:
    2005
  • On CPHI since:
    2026
  • Certificates:
    1
  • Employees:
    100 - 249
Company types
Contract Service
IT/Software solution provider
Primary activities
OTC
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Technology
View company profile