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

CONSULTING AND TRAINING

Data Integrity Compliance

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.

OUR EXPERIENCE

Some of Our Projects

Implementation and validation of warehouse management systems, and integration with the ERP system

Assessment of the control system for filling/packaging machines

Assessment and Remediation of the Company Information System

BENEFITS

Why choose S4BT for CSV and
Data Integrity Compliance

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

OUR CLIENTS

What they say about us

I asked S4BT for help at a difficult time on a validation activity that had never been performed before, and I got the right support despite the tight deadlines of the request. My level of satisfaction is very good and I would like to work with S4BT again in the future because once I had entrusted the task, all I had to do was review the documents/tests done, being sure of their competence. I would like to point out one activity that struck me in particular: the validation of the data logger (which had never been done before), made difficult by the number of exceptions and the flaws in the system.

CLIENTS