- + 39 0773.694245
- Mon → Fri: 9.00 a.m. – 5.00 p.m.
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We offer an innovative outsourcing service for the execution of Process, Packaging & Cleaning Validation activities in pharmaceutical companies.
S4BT has twenty years of experience in Computer System Validation (CSV). We validate computer systems for new installations or upgrades in compliance with reference regulations and guidelines.
S4BT has twenty years of experience in Computer System Validation (CSV). We validate computer systems for new installations or upgrades in compliance with reference regulations and guidelines.
We offer a bespoke consulting service for pharmaceutical, API, medical device, biotech, and pharmaceutical-related companies.
We manage instrument calibration, revamping projects, and the qualification and re-qualification of equipment, systems, and utilities with our own (LAT, SIT, EA) certified scientific instrumentation.
We offer a bespoke consulting service for pharmaceutical, API, medical device, biotech, and pharmaceutical-related companies.
We manage instrument calibration, revamping projects, and the qualification and re-qualification of equipment, systems, and utilities with our own (LAT, SIT, EA) certified scientific instrumentation.
TOGETHER IS BETTER.
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