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:
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.
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.
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
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