IT & Computer System Validation

S4BT has twenty years’ experience in Computer System Validation (CSV).

We validate computer systems for new installations or upgrades in compliance with the reference regulations and guidelines, in particular CFR 21, Eudralex Vol.4.

Network monitoring tools, Firmware, COTS, Laboratory Computerised Systems, LIMS, ERP, SCADA, Spreadsheets, Custom software, etc.

We also provide consulting for:

  • CFR 21 part 11/EU Gap Analysis
  • Annex 11
  • Supplier Software Selection
  • Drafting of Administration SOPs
  • Periodic Audit Trail Review
  • Network infrastructure qualification
S4BT - Computer system validation
S4BT - computer system validation

Data Integrity

S4BT has been working in Data Integrity for many years and offers a consulting services based on the latest methodologies for the implementation of a corporate data integrity plan, starting from a careful analysis of the compliance of systems managing electronic and printed data with the principles of data integrity.

We support all system assessments (with a preliminary check on compliance with 21 CFR Part 11/Annex 11) and document packages relating to GMPs.

We also bring our knowledge and experience of Data Integrity to the table. We provide training courses tailored to all company levels, from basic to advanced, mainly for individuals involved in Data Governance and Quality Management.


Some of Our Projects


Why choose S4BT for CSV and Data Integrity

Complete document package (ITA-EN) that meets the most critical regulatory conditions
Risk-based approach based on Quality Risk Management principles
Internal network of multidisciplinary skills for an integrated approach with the qualification of plant, systems, utilities
Full compliance with FDA and EMA regulations and guidelines and other specific standards
Twenty years of experience in Computer System Validation
Projects supervised by PMP-certified project managers
Highly specialised training on CSV and Data Integrity
Client support during every phase of the validation process, from URS to system implementation

What they say about us


Request more information

Fill out the form and tell us about your requirements.
One of our consultants will contact you as soon as possible.


An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes


Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes