S4BT - Solutions for Business and Technology

S4BT is an Italian company with over 100 professionals specializing in consulting services and GxP-compliant software solutions for the Pharmaceutical and Life Sciences industry. Since 1995, we have supported organisations in achieving operational excellence through technical expertise, regulatory compliance, and digital innovation. 

Our consulting services cover MS&T, Quality & Compliance, Computer System Validation, and Commissioning & Qualification. Through PRAGMA4U, our AI-enabled all-in-one GxP platform, we help companies automate processes, improve efficiency, centralize knowledge, and maintain continuous regulatory compliance.

MS&T Consulting Service

• Process validation

• Cleaning validation & requalification

• Packaging validation

• Continued Process Verification

• New product introduction

• Technology Transfer

• Continuous Manufacturing Line validation

• Artwork Management

• Packaging Engineering support

• Shipping validation

• MS&T Project Management

Computer System Validation

• Manufacturing and packaging system validation

• SCADA validation, optimization and control

• Laboratory instrument validation

• System requalification

• Data integrity analisys

• System audit trail review

• Access Management

• Digitalization and migration

• ERP validation

• IT/OT infrastructure design and validation

• Automation system validation

• Artificial intelligence design and Validation

Quality & Compliance

• Batch record review

• Master Data Operations

• QA on the floor

• Deviation Management & CAPA

• Change Management

• Sterility Quality Assurance

• External audit (GxP)

• Self inspection – Internal audit

• Moc inspection

• Training & Documentation Management

• Quality Project Management

Commissioning & Qualification

• Engineering support

• FAT and SAT support

• New equipment qualification

• Calibration service

• Utilities Qualification

• Environmental mapping

• HVAC monitoring and qualification

• Periodic Requalification

• Process Engineering support

• Engineering Project Management

PRAGMA4U - All-in-one Platform

> 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.

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.