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Client: an important chemical-pharmaceutical multinational engaged in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices.
Sector: chemical-pharmaceutical
Objective: to develop new pharmaceutical processes for new formulations.
The client company is a leading global chemical-pharmaceutical company,
engaged for decades in the development of new medicines and the introduction of cutting-edge
technologies and innovative health management practices. The Client saw the need for dedicated and focussed analytical support for the creation of tests and analyses, in order to develop new pharmaceutical processes for new formulations.
For the project in question, the Client co-operated closely with the S4BT Lab consultants, who focussed mainly on the analytical part, conducting:
The results of the analyses conducted provided the necessary information, satisfying the requirements of the Client, who thus obtained valuable support for the development of new pharmaceutical
processes.
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Pharmaceutical Company
An international pharmaceutical contract manufacturer specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.
Digital Company
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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