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

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

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
Consultancy
IT/Software solution provider
Primary activities
Biopharmaceutical
Medical Devices
OTC
Pharmaceutical Company (generic finished products)
Pharmaceutical Company (innovator finished products)
Technology
View company profile
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

    WFM (Workflow Management System)


    Tailored solutions
    We listen to your needs and analyze your processes and your company’s context. We design the digital workflow in full compliance with relevant regulations. We also offer a validation service and support your company throughout the technology implementation process.

    .
  • 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.
More specifications Fewer specifications

S4BT | PRAGMA4U

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

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S4BT | PRAGMA4U resources (3)

  • S4BT - Website

    Brochure S4BT - Website

  • PRAGMA4U - Website

    Brochure PRAGMA4U - Website

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

    Video 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 activitiesCentralize process management and corporate know-howImprove operational efficiencyEnsure continuous compliance with regulatory requirements
    2026-08-24