We offer a tailor-made consulting service for pharmaceutical companies, APIs, medical devices, biotechnology and pharmaceutical satellite activities.
We deal with instrument calibration, revamping projects, and qualification and re-qualification of equipment, systems and utilities with our own (LAT, SIT, EA) certified scientific instrumentation.
We handle the preparation of the qualification document package through the direct application of Quality Risk Management principles:
Our consulting services include the implementation of ,periodic testing of qualification and requalification protocols and of manufacturing equipment, and support in the execution of FAT and SAT during commissioning.
Thanks to our team of Qualification Engineers , we can satisfy the most critical regulatory conditions, ensuring full compliance with international guidelines and GMP standards, particularly those of the FDA and EMA.
PMP-certified project managers supervise the projects, ensuring their completion on-time and on-budget. We monitor the process and constantly update the client, to facilitate co-operation and achievement of the shared goal.
Our twenty years of experience with SMEs in the sector have made us a reliable partner, capable of supporting our customers with high workloads, in preparation for inspections, or for support with skills.
Systems for the production, distribution and storage of:
HVAC systems and controlled contamination areas:
The work of the S4BT consultants positively influenced the activities they addressed for our company, both with regard to the possibility of comprehensive and complete compliance with FDA observations and in the improvement of maintenance activities in some controlled contaminated areas. I thoroughly enjoyed working with the S4BT consultants and I remain highly satisfied. I would like to work with them again in the future, because they have the right combination of skill, professionalism, flexibility and co-operation. Excellent work on environmental controls and thermal monitoring, as well as on IQ/OQ activities.
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