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Client: The client company is one of the leading chemical-pharmaceutical companies in the world,
engaged for decades in the development of new medicines and in the introduction of cutting-edge
technologies and innovative ways of managing health.
Sector: chemical-pharmaceutical
Objective: to carry out stress testing and stability studies on certain formulations (in order to obtain available data on the onset of impurities and on the setting of specification limits).
The client chose to cooperate with the S4BT Laboratory consultants, who focused on:
The project allowed the client to further strengthen a production approach oriented towards quality and continuous improvement, in compliance with ICH guidelines and internal policies.
The study has proved effective and invaluable and has been used in the client’s facilities all over the world.
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Pharmaceutical Company
An international pharmaceutical organisation specialising in the clinical and commercial development and production of pharmaceutical products with a high degree of toxicity.
Digital Company
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Petshop Company
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Conditioner Company
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Card Rental
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Expedition 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